Acronyms
- ACP - American College of Physicians
- ACR - American College of Radiology
- APS - American Pain Society
- BMJ - British Medical Journal
- LBP - Low back pain
- MRI - Magnetic resonance imaging
- NSAID - Nonsteroidal anti-inflammatory drugs
- OBS - Observational study
- PT - Physical therapy
- RCT - Randomized controlled trial
- RD - Radiofrequency denervation
- TENS - Transcutaneous electrical nerve stimulation
OVERVIEW
- Low back pain, one of the most common complaints in primary care, affects up to 84% of people at some point in their lives and is chronic in 23% of the population. It is estimated that over 300 billion dollars is spent annually in the U.S. on LBP and neck pain, making spine disorders the number one healthcare expenditure. [1,75]
TERMS AND DEFINITIONS
- Spine anatomy
- The spine is divided into six areas: cervical vertebrae, thoracic vertebrae, lumbar vertebrae, sacrum, and coccyx. Vertebrae are round bones separated by cartilage discs with extensions in the back that form a ring around the spinal cord. The intervertebral discs provide cushioning and allow the spine to bend.
- Disc protrusion
- Disc protrusions (also called bulging discs, slipped discs, and herniated discs) occur when a cartilage disc protrudes from underneath a vertebra. The disc may touch or encroach on the spinal cord or a nerve root, sometimes producing pain. Protrusions may occur to one side or be broad-based, where the entire face of the disc is involved.
- Disc extrusion
- Disc extrusions (also called ruptured discs) occur when the annulus fibrosus tears and the gel-like nucleus pulposus extrudes through it
- Disc sequestration
- Disc sequestration occurs when a portion of the gel-like nucleus pulposus extrudes and then separates from the main disc
- Radiculopathy
- Radiculopathy is pain from nerve root compression, which may be caused by a herniated disc or vertebral bony malformations. Symptoms of radiculopathy include pain and/or weakness in the distribution of the affected nerve (see sciatica).
- Schmorl's node
- Schmorl's nodes are herniations of the nucleus pulposus into the vertebra above or below the discs. They are common, occurring in up to 70% of the population, and often found incidentally on spine imaging. Their association with back pain is unclear. [65]
- Sciatica
- The sciatic nerve, which contains sensory and motor fibers, originates from the L4 - S3 nerve roots and runs down the back of the leg. Herniated discs in the lower spine pressing on sciatic nerve roots can cause pain, weakness, tingling, and/or numbness in the leg, a condition called sciatica. Symptom distribution depends on the affected nerve, as described below.
- L4 nerve - the hip, thigh, inner knee, and calf
- L5 nerve - buttocks, outer thigh, anterior calf, and top of foot
- S1 nerve - buttocks, posterior leg and calf, and side of foot
- Spondylolysis
- Spondylolysis is stress fractures in the pars interarticularis, joints that articulate with the adjacent vertebral bodies. See spondylolysis review for more.
- Spondylosis
- Spondylosis is degenerative changes of the discs and vertebral bodies that occur with age. Radiologic signs of spondylosis include osteophyte formation (bone spurs), disc space narrowing, bulging or herniated discs, and bony sclerosis.
- Spondylolisthesis
- Spondylolisthesis is a condition where one vertebral body is displaced forward in relation to the one below it. There are two types of spondylolisthesis. Degenerative spondylolisthesis occurs when osteoarthritic changes in the pars interarticularis joint create laxity, allowing the vertebral body above to move forward. Spondylolytic spondylolisthesis is caused by stress fractures in the pars interarticularis, which allow slippage. See spondylolisthesis review for more.
- Spondylitis
- Spondylitis is vertebral body inflammation. Causes may be infectious or autoimmune (e.g., ankylosing spondylitis).
TYPES OF LBP
LBP Cases in Primary Care | |
---|---|
Etiology | Prevalence |
Nonspecific LBP | 70% |
Age-related degenerative changes of the spine | 10% |
Disc disease | 4% |
Compression fracture | 4% |
Spinal stenosis | 3% |
Spondylolisthesis | 2% |
Cancer | 0.7% |
Inflammatory arthritis (e.g., ankylosing spondylitis) |
0.3% |
All other | 6% |
- Nonspecific LBP (70 - 80% of LBP cases)
- Overview
- Nonspecific LBP, also referred to as musculoskeletal back pain, mechanical low back pain, and lumbar strain, is by far the most common cause of LBP, accounting for 70 - 80% of cases
- Pathology
- Nonspecific LBP is back pain with no identifiable pathology (e.g., fracture, herniated disc)
- Symptoms
- Nonspecific low back pain often presents as a general aching across the lower back that is worsened by prolonged standing and/or physical activity
- Risk factors
- Family history
- Obesity
- Occupational factors (work-related lifting, carrying, pushing, pulling, walking, standing, etc.)
- Psychological factors
- Physical activity / Deconditioning
- Smoking [1,5-16]
- Treatment
- Disc disease (4% of LBP cases)
- Pathology
- Disc disease is caused by spinal cord or nerve root compression from a herniated disc (see disc protrusion illustration)
- Symptoms
- Symptoms, which may occur suddenly or progress gradually, include pain, numbness, tingling, and/or weakness in the distribution of the affected nerve (see sciatica)
- Risk factors
- No definitive risk factors have been identified [17]
- Treatment
- Spinal stenosis (3% of LBP cases)
- Pathology
- Spinal stenosis is narrowing of the lumbar canal due to degenerative changes, including disc disease, ligamentum flavum thickening, osteoarthritic bone and joint disease, and spondylolisthesis. Collectively, these changes exert pressure on the spinal cord, producing symptoms (see spinal stenosis illustration)
- Symptoms
- Spinal stenosis causes pain and weakness in the buttocks, thighs, and lower legs that are worsened by prolonged walking or standing and relieved by leaning over or sitting (neurogenic claudication). [3]
- Risk factors
- Advanced age - age > 60 years is the most important risk factor
- History of chronic steroid use
- Paget's disease
- History of disc or spine disorders (e.g., disc disease, spondylolisthesis) [3]
- Treatment
- Compression fractures (4% of LBP cases)
- Pathology
- Vertebral compression fractures are collapsed vertebrae, which may occur acutely from mild trauma (e.g., sneezing, lifting small objects) or develop gradually over time. In some cases, they are asymptomatic and discovered incidentally on imaging. The most common vertebrae affected are T8 through T12, L1, and L4. See vertebral compression fracture illustration.
- Symptoms
- Acute fractures may cause sudden back pain, while slowly progressive ones may be asymptomatic or present with gradually worsening pain. Compressed vertebrae can lead to kyphosis (hunched-over posture) and loss of height.
- Risk factors
- Advanced age - > 65 for men and 75 for women
- Females
- History of chronic steroid use
- Osteoporosis
- Trauma
- Very thin or frail
- White or Asian race [18]
- Treatment
- Other causes
- Cancer - cancer, including bony metastasis, should be considered in patients with a history of malignancy or concerning symptoms (e.g., unexplained weight loss)
- Infection - risk factors for infectious spondylitis include IV drug abuse, recent bacterial infection, surgery, organ transplant recipient, and immunosuppression
- Cauda equina syndrome - cauda equina syndrome is a rare but serious condition involving severe compression of the nerves leaving the bottom of the spinal cord. Symptoms include inability to urinate or control bowel movements, loss of sensation around the rectum, and leg weakness. Causes include lower spine tumors and massive midline disc herniation. It is a medical emergency requiring prompt surgery to prevent permanent disability. [4]
- Ankylosing spondylitis - ankylosing spondylitis is a chronic inflammatory spine condition marked by vertebral body fusion and reduced flexibility. It typically presents in younger patients (< 30 years old) and is more common in men. More than 90% of affected patients have the HLA-B27 haplotype. Bony growth within spinal ligaments (syndesmophytes) and sacroiliitis are typical X-ray findings. [2]
DIAGNOSIS
- History
- Most LBP etiologies can be determined from the medical history. General aching and soreness across the lower back that is worse with prolonged standing or activity is typical of nonspecific LBP. Pain, numbness, and/or tingling that radiates into the lower extremities is consistent with disc disease. Spinal stenosis should be considered in older patients with buttocks, hip, thigh, and/or leg symptoms. Frail elderly patients with sudden or gradual pain in a specific region of the back should be evaluated for vertebral compression fractures. In certain cases (e.g., fever, IV drug abuser, history of cancer, trauma), other etiologies should be considered.
- Physical exam
- The most useful exam is the straight leg raise (straight leg raise video), which can help distinguish between nonspecific LBP and disc disease. In studies, it has a sensitivity of 92% and a specificity of 28%, which means a negative test is helpful in ruling out disc disease but a positive test doesn't mean it is likely. Other exam findings, including lower extremity reflexes and motor strength, are mostly nonspecific, highlighting the importance of the medical history. [21]
- Imaging
- Imaging for LBP is controversial, as it accounts for considerable healthcare expenditures and oftentimes has little impact on treatment decisions. Regardless of the etiology, LBP often improves, and early imaging has not been found to affect outcomes. Furthermore, many abnormalities found on imaging, including herniated discs, spondylolisthesis, spondylolysis, and canal stenosis, are present in people without back or leg pain, making it difficult at times to know if findings are incidental or causal (see MRI findings in patients without pain). [25,66]
- LBP imaging recommendations from the ACP and APS are provided below. ACR red flag findings that may indicate a serious underlying condition favoring imaging are also listed, although, in studies, they perform poorly as predictors of serious etiologies.
- ACP/APS recommendations for LBP imaging
- Clinicians should not routinely order radiological studies for nonspecific low back pain
- Clinicians should order radiological studies when severe or progressive neurological deficits are present or when serious underlying conditions are suspected
- Clinicians should order an MRI (preferred) or CT scan in patients with persistent (> 4 weeks) low back pain and signs and symptoms of disc disease only if they are potential candidates for surgery or epidural spinal injections [20]
- ACR LBP "red flag" findings that may indicate a serious underlying condition
- History of cancer
- Unexplained weight loss
- Immunosuppression
- Urinary infection
- Intravenous drug use
- Prolonged use of corticosteroids
- Back pain not improved with conservative management
- History of significant trauma
- Minor fall or heavy lift in a potentially osteoporotic or elderly individual
- Prolonged use of steroids
- Acute onset of urinary retention or overflow incontinence
- Loss of anal sphincter tone or fecal incontinence
- Saddle anesthesia
- Global or progressive motor weakness in the lower limbs
- Prior back surgery [24]
MRI findings in 98 people (average age 42 years) with no LBP | |
---|---|
MRI finding | % of people |
Disc bulge | 52% |
Disc protrusion | 27% |
Schmorl's nodule | 19% |
Disc extrusion | 1% |
MRI findings in 67 people without LBP | ||||
---|---|---|---|---|
Age range | Herniated disc | Bulging disc | Degenerative disc | Spinal stenosis |
20 - 39 years (N=35) |
21% | 56% | 34% | 1% |
40 - 59 years (N=18) |
22% | 50% | 59% | 0% |
60 - 80 years (N=14) |
36% | 79% | 93% | 21% |
- Imaging studies
- X-ray - X-rays are useful for identifying bony abnormalities, including vertebral compression fractures, degenerative changes, spondylolysis, and spondylolisthesis
- MRI - MRI provides images of the bones, ligaments, nerve roots, and spinal cord, making it the preferred study for evaluating disc disease and spinal stenosis
- CT scan - CT scans allow visualization of the bones, spinal cord, and discs. Bone images are superior to MRI, while disc and spinal cord images are inferior.
- CT myelogram - CT myelogram is a CT scan where contrast is infused around the spinal cord to improve visualization of the canal. It is sometimes ordered when metallic hardware, which can distort MRI images, is present from previous surgeries.
- Nerve conduction studies (NCS) and electromyography (EMG) - NCS and EMG measure nerve and muscle electrical activity in the arms and legs. Rarely, they are used to detect disc disease in the lower extremities.
PROGNOSIS / NATURAL COURSE
- Nonspecific LBP
- Most people with acute nonspecific LBP will improve within a few weeks to several months. Recurrence within a year is seen in up to 73% of patients, while chronic LBP (> 3 months) develops in 10 - 15%. [1,4,26]
- Factors associated with continued pain and/or disability
- Worrying and health anxiety
- Claims for compensation/disability
- Minimal or no exercise in leisure time
- More intense pain
- Longer duration of pain
- Fear/avoidance of physical activity
- Doubt over returning to work [27]
- Disc disease
- Most people who experience disc disease symptoms recover in 3 - 5 months. In one review, 60% of patients with disc disease had a marked decrease in leg and back pain by 2 months. At one year, pain persisted in 20 - 30% of patients. [30] In another study, 36% of patients with sciatica showed major improvement in 2 weeks, and 73% showed reasonable to major improvement after 12 weeks. [29]
- Disc abnormalities on imaging also improve in most patients. The table below shows the natural course of disc disease on MRI in 154 patients (average age 45 years) with sciatica who were followed for 14 months. All patients were treated conservatively (i.e., no surgery).
Change in Disc Disease Findings on MRI over 14 Months in 154 Symptomatic Patients | |||
---|---|---|---|
Finding | Improved | Unchanged | Worse |
Bulging disc (bulge > 50% of vertebral rim) |
21% | 67% | 12% |
Broad-based disc protrusion (herniation of 25 - 50% of disc circumference) |
80% | 20% | 0% |
Focal disc protrusion (herniation of < 25% of disc circumference) |
65% | 23% | 12% |
Disc extrusion | 78% | 14% | 8% |
Disc sequestration | 75% | 25% | 0% |
- Spinal stenosis
- A study in the journal Spine followed 49 patients with spinal stenosis for 3 years. Patients were given aggressive nonsurgical treatment (e.g., steroid injections, physical therapy, medications). After an average follow-up of 33 months, the following was seen:
- Nine patients (18%) received surgery because they did not improve. Of these patients, 78% had severe stenosis on MRI versus 38% in those not receiving surgery.
- In patients who did not receive surgery, 65% had improvement in their pain, 18% were worse, and 17% were the same. For functional outcomes, 40% had improvement, 25% were worse, and 35% were the same. [34]
- Vertebral compression fractures
- Vertebral compression fractures typically cause acute back pain that improves over a period of 3 months. Chronic pain will develop in 40% of patients. [37]
TREATMENT | Nonspecific LBP
- Overview
- Nonspecific LBP is treated with exercises, stretching, medications like NSAIDs, acetaminophen, muscle relaxers, and perhaps, most importantly, time, as most nonspecific LBP improves within a month. Long-term prevention involves core muscle strengthening since weak abdominal and lower back muscles play a significant role. Many patients are referred for physical therapy, which may benefit patients with poor exercise habits. However, evaluating the effects of physical therapy in trials is difficult since the control group is unblinded, preventing correction for a placebo effect.
- A study comparing early physical therapy to usual care is reviewed below. Studies enrolling patients with nonspecific LBP evaluating TENS units and duloxetine are also reviewed. Core strengthening exercises for LBP are available here - low back pain workout
RCT
Early Physical Therapy vs Usual Care for Nonspecific LBP, JAMA (2015) [PubMed abstract]
- A trial in the JAMA enrolled 220 patients with LBP symptoms for less than 16 days
Main inclusion criteria
- Pain between 12th rib and buttocks
- ODI score ≥ 20
- Symptom duration < 16 days
- No pain or numbness distal to the knees in the past 72 hours
Main exclusion criteria
- Prior lumbar surgery
- Any other LBP treatment in the past 6 months
- Clinical signs of nerve root compression (e.g. hyporeflexia)
Baseline characteristics
- Average age 37 years
- Average BMI - 29
- Average ODI score - 41
- NSAID therapy - 66%
- Opiate therapy - 27%
Randomized treatment groups
- Group 1 (108 patients) - Early physical therapy (4 sessions over 3 weeks starting within 72 hours of randomization)
- Group 2 (112 patients) - Usual care
- All participants were given a copy of The Back Book
Primary outcome: Change in the Oswestry Disability Index (ODI) score at 3 months. The ODI score ranges from 0 - 100 with higher scores indicating
greater disability. The minimum clinically important difference was predetermined to be 6 points.
Results
Duration: 1 year | |||
Outcome | Physical therapy | Usual | Comparisons |
---|---|---|---|
Change in ODI at 3 months | -34.5 | -31.3 | difference -3.2, 95% CI [-5.9 to -0.47], p=0.02 |
Change in ODI at 4 weeks | -30 | -26.6 | difference -3.5, 95% CI [-6.8 to -0.08], p=0.045 |
Change in ODI at 1 year | -34.1 | -32.1 | difference -2.0, 95% CI [-5.0 to 1.0], p=0.19 |
|
Findings: Among adults with recent-onset LBP, early physical therapy resulted in statistically significant improvement in disability, but the improvement was modest and did not achieve the minimum clinically important difference compared with usual care.
TREATMENT | Disc disease
- Overview
- Disc disease may be treated conservatively (e.g., physical therapy, medications, spine injections) or surgically. Three studies comparing conservative therapy to surgery are reviewed below, along with a study evaluating the effects of epidural injections.
RCT
SPORT trial - Open Discectomy vs Nonoperative Treatment for Lumbar Disc Herniation, JAMA (2006) [PubMed abstract]
- The SPORT trial enrolled 501 patients with lumbar disc herniation
Main inclusion criteria
- Herniation confirmed by imaging
- Symptoms for ≥ 6 weeks that did not respond to nonoperative treatment
- Radicular symptoms
- Positive straight leg raise or neurologic deficit
Main exclusion criteria
- Prior lumbar surgery
- Cauda equina syndrome
- Inflammatory spondyloarthropathy
Baseline characteristics
- Average age 42 years
- Less than 6 months since onset - 78%
- Received PT - 67%
- Taking opioid - 40%
- Received epidural injection - 42%
- Herniation level: L2 to L4 - 7% | L4/5 - 34% | L5/S1 - 59%
- Herniation type: Protruding - 26% | Extruded - 66% | Sequestered - 7%
Randomized treatment groups
- Group 1 (245 patients) - Surgical open discectomy
- Group 2 (256 patients) - Nonoperative treatment
- Nonoperative treatment was not standardized but typically included medications, injections, physical therapy, and education
- Surgery was to be performed within 6 months of enrollment
Primary outcome: Change in SF-36 score (bodily pain and physical function scale, 0 - 100, higher scores indicate less severe symptoms) and
Oswestry Disability Index (ODI) score (range 0 - 100, lower scores indicate less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years
Results
Duration: 2 years | |||
Outcome | Discectomy | Conservative | Comparisons |
---|---|---|---|
Decrease in ODI at 1 year | 30.6 | 27.4 | diff 3.2, 95%CI [-7.8 to 1.3] |
Decrease in ODI at 2 years | 31.4 | 28.7 | diff 2.7, 95%CI [-7.4 to 1.9] |
Increase in SF-36 bodily pain at 1 year | 39.7 | 36.9 | diff 2.8, 95%CI [-2.3 to 7.8] |
Increase in SF-36 bodily pain at 2 years | 40.3 | 37.1 | diff 3.2, 95%CI [-2.0 to 8.4] |
|
Findings: Patients in both the surgery and the nonoperative treatment groups improved substantially over a 2-year period. Because of the large numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis
RCT
Microdiscectomy vs Conservative Treatment for Severe Sciatica, NEJM (2007) [PubMed abstract]
- A trial in the NEJM enrolled 283 patients with severe sciatica
Main inclusion criteria
- 18 - 65 years of age
- Disc herniation confirmed by imaging
- Incapacitating radicular syndrome for 6 - 12 weeks
Main exclusion criteria
- Cauda equina syndrome
- Previous spine surgery
- Bony stenosis
- Spondylolisthesis
- Muscle paralysis
- Insufficient strength to move against gravity
- prior episode within previous 12 months
Baseline characteristics
- Average age 42 years
- Average duration of sciatica - 9.46 weeks
- Muscle weakness - 68%
- Average Roland Disability Score - 16.4
- Average VAS (leg pain) - 65
- Level of herniation: L3/4 - 4% | L4/5 - 44% | L5/S1 ∼ 52%
Randomized treatment groups
- Group 1 (141 patients) - Surgical microdiscectomy
- Group 1 (142 patients) - Conservative treatment
- Conservative treatment was not standardized and included education, medications, and physical therapy as needed
- If sciatica persisted for > 6 months in Group 2, microdiscectomy was offered. Patients in Group 2 with progressive leg pain or neurologic deficits were offered surgery earlier than 6 months.
Primary outcome: Measures on the Roland Disability Questionnaire (RDQ) (scale 0 - 23 with higher scores indicating worse functional status),
the 100 mm visual-analogue scale (VAS) for leg pain (0 is no pain, 100 is worst pain), and a 7-point Likert self-rating scale of global perceived recovery during the first year after randomization
Results
Duration: 1 year | |||
Outcome | Discectomy | Conservative | Comparisons |
---|---|---|---|
RDQ score at 26 weeks | 4.0 | 4.8 | diff 0.8, 95%CI [-0.5 to 2.1] |
RDQ score at 52 weeks | 3.3 | 3.7 | diff 0.4, 95%CI [-0.9 to 1.7] |
VAS for leg pain at 8 weeks | 10.2 | 27.9 | diff 17.7, 95%CI [12.3 to 23.1] |
VAS for leg pain at 26 weeks | 8.4 | 14.5 | diff 6.1, 95%CI [2.2 to 10] |
VAS for leg pain at 52 weeks | 11 | 11 | diff 0, 95%CI [-4 to 4] |
|
Findings: The 1-year outcomes were similar for patients assigned to early surgery and those assigned to conservative treatment with eventual surgery if needed, but the rates of pain relief and of perceived recovery were faster for those assigned to early surgery.
- RCTMicrodiskectomy vs Conservative Treatment for Sciatica Lasting 4 - 12 Months, NEJM (2020) [PubMed abstract]
- Design: Randomized controlled trial (N=128 | length = 6 months) in patients with unilateral radiculopathy for 4 to 12 months and findings on MRI of posterolateral herniation of the disk between L4 and L5 or L5 and S1 on the appropriate side, with compression of the corresponding nerve root
- Treatment: Microdiskectomy vs Conservative treatment for a minimum of 6 months
- Primary outcome: Leg pain intensity score on the visual analogue scale (ranging from 0 to 10, with higher scores indicating a greater intensity of pain) at 6 months after randomization
- Results:
- Baseline leg pain intensity score: Microdiskectomy - 7.7, Conservative therapy - 8.0
- Primary outcome: Microdiskectomy - 2.8, Conservative therapy - 5.2 (p<0.001)
- In the Microdiskectomy group, 12.5% of patients did not receive surgery. In the Conservative therapy group, 97% of patients were continuing to receive nonsurgical care at 6 months.
- Findings: In this single-center trial involving patients with sciatica lasting more than 4 months and caused by lumbar disk herniation, microdiskectomy was superior to nonsurgical care with respect to pain intensity at 6 months of follow-up.
RCT
Epidural injections vs Sham Injections for Sciatica, BMJ (2011) [PubMed abstract]
- A trial in the BMJ enrolled 116 patients with symptoms of disc disease for at least 12 weeks
Main inclusion criteria
- Unilateral sciatica for ≥ 12 weeks
- Age 20 - 60 years
- Leg pain worse than back pain
Main exclusion criteria
- Severe pain
- History of spinal injection or surgery
- BMI > 30
- Treatment with NSAIDs
Baseline characteristics
- Average age 42 years
- Average BMI 26.4
- Disc herniation ∼ 65%
- Disc sequestration ∼ 33%
Randomized treatment groups
- Group 1 (40 patients) - Sham injections (2 mls of saline injected subcutaneously)
- Group 2 (39 patients) - Caudal epidural saline injection (30 ml of saline)
- Group 3 (37 patients) - Caudal epidural steroid injection (40 mg triamcinolone in 29 ml of saline)
- All 3 groups received 2 injections 2 weeks apart
Primary outcome: Change in score on the Oswestry Disability Index (ODI) at 6, 12, and 52 weeks. The ODI scale ranges from 0 - 100 with
higher scores indicating more severe symptoms.
Results
Duration: 52 weeks | ||||
Outcome | Sham | Saline | Steroid | Comparisons |
---|---|---|---|---|
Mean baseline ODI | 26.3 | 31.4 | 32.5 | N/A |
|
Findings: Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy
- Summary
- Surgical studies for disc disease are hampered by high crossover rates, which bias the study towards the null, and a lack of sham procedure in the control group, leaving participants unblinded and susceptible to a placebo effect. It is difficult to draw meaningful conclusions from the three studies above, as they all suffered from these weaknesses.
- Steroid injections were not superior to saline or sham injections in the epidural injection trial. A study in patients with spinal stenosis (see LESS trial) also found they offer no real benefit. The BMJ 2025 spine procedure guidelines do not recommend epidural injections for radiculopathy.
- Patients with disc disease should consider its natural course before undergoing surgical treatment.
TREATMENT | Spinal stenosis
- Overview
- Spinal stenosis may be treated surgically or conservatively (e.g., physical therapy, medications, injection). Surgical treatment starts with a laminectomy, which relieves pressure in the spinal canal (laminectomy illustration). Other decompressive procedures, including discectomy and foraminotomy, may also be performed. Lastly, spinal fusion, binding two vertebral bodies together with rods, screws, and a bone graft (spinal fusion illustration), is often performed. Theoretically, spinal fusion stabilizes the anatomy and reduces the risk of nerve impingement, particularly in patients with spondylolisthesis.
- Studies evaluating spinal stenosis therapies, including surgery vs. conservative therapy, laminectomy with and without fusion, epidural steroids, and spinal cord stimulators, are reviewed below.
RCT
SPORT trial - Surgery vs Conservative Therapy for Spinal Stenosis, NEJM (2008) [PubMed abstract]
- The SPORT trial enrolled 289 patients with spinal stenosis without spondylolisthesis
Main inclusion criteria
- Neurogenic claudication or radicular leg symptoms for ≥ 12 weeks
- Lumbar spinal stenosis on imaging at ≥ 1 level
Main exclusion criteria
- Spondylolisthesis
- Lumbar instability on X-ray
Baseline characteristics
- Average age 66 years
- Symptoms > 6 months - 57%
- Neurogenic claudication - 79%
- Mean SF-36 score (bodily pain) - 32
- Average ODI score - 43
- Levels with moderate-to-severe stenosis: 1 - 38% | 2 - 29% | ≥ 3 - 21%
Randomized treatment groups
- Group 1 (138 patients) - Surgical decompressive laminectomy
- Group 2 (151 patients) - Conservative treatment
- Conservative treatment was not standardized but was to include physical therapy, education, and NSAIDs
Primary outcome: Average change from baseline on the SF-36 score (bodily pain and physical function scale, 0 - 100, higher scores indicate less severe symptoms) and
modified Oswestry Disability Index (ODI) score (range 0 - 100, lower scores indicate less severe symptoms) at 6 weeks, 3 months, 6 months, and 1 and 2 years
Results
Duration: 2 years | |||
Outcome | Surgery | Conservative | Comparisons |
---|---|---|---|
Increase in SF-36 bodily pain at 6 months | 21 | 16 | diff 4.9, 95%CI [-1.2 to 10.9] |
Increase in SF-36 bodily pain at 1 year | 23 | 17.5 | diff 5.5, 95%CI [-0.7 to 11.7] |
Increase in SF-36 bodily pain at 2 years | 23.4 | 15.6 | diff 7.8, 95%CI [1.5 to 14.1] |
Decrease in ODI at 6 months | 14.6 | 13.7 | diff 0.9, 95%CI [-5.9 to 4.1] |
Decrease in ODI at 1 year | 14.9 | 12.7 | diff 2.2, 95%CI [-7.4 to 2.9] |
Decrease in ODI at 2 years | 16.4 | 12.9 | diff 3.5, 95%CI [-8.7 to 1.7] |
|
Findings: In the combined as-treated analysis, patients who underwent surgery showed significantly more improvement in all primary outcomes than did patients who were treated nonsurgically
RCT
Surgery vs Conservative Treatment for Spinal Stenosis, Spine (2007) [PubMed abstract]
- A trial published in the journal Spine enrolled 94 patients with spinal stenosis
Main inclusion criteria
- Symptoms of spinal stenosis
- Spinal stenosis on imaging
- Symptoms for > 6 months
Main exclusion criteria
- Severe stenosis with intractable pain and progressive neurologic dysfunction
- Spondylolysis and spondylolytic spondylolisthesis
- Previous spinal stenosis surgery
Baseline characteristics
- Average age 62 years
- Average length of symptoms - 15 years
- Daily pain during the last month - 77%
- Degenerative spondylolisthesis - 42%
- Average ODI score - 34.5
Randomized treatment groups
- Group 1 (50 patients) - Surgical decompressive laminectomy and fusion if indicated
- Group 2 (44 patients) - Conservative treatment (physical therapy, NSAIDs, and education)
Primary outcome: Score on the Oswestry Disability Index (ODI) (scale 0 – 100 with lower scores indicating less severe
symptoms) at 6, 12, and 24 months
Results
Duration: 2 years | |||
Outcome | Surgery | Conservative | Comparisons |
---|---|---|---|
Primary outcome (6 months) | 20.7 | 28.3 | diff 7.6, 95%CI [1.3 to 13.9] |
Primary outcome (1 year) | 18.9 | 30.2 | diff 11.3, 95%CI [4.3 to 18.4] |
Primary outcome (2 years) | 21.2 | 29 | diff 7.8, 95%CI [0.8 to 14.9] |
|
Findings: Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these differences persist.
RCT
Swedish Spinal Stenosis Study (SSSS) - Laminectomy + Fusion vs Laminectomy Alone in Spinal Stenosis, NEJM (2016) [PubMed abstract]
- The SSSS enrolled 247 patients with spinal stenosis with and without spondylolisthesis
Main inclusion criteria
- Age 50 - 80 years
- Neurogenic claudication lasting ≥ 6 months
- 1 - 2 stenotic segment between L2 and the sacrum on MRI
Main exclusion criteria
- Spondylolysis
- Degenerative scoliosis
- Stenosis caused by herniated disc
- Stenosis not caused by degenerative changes
Baseline characteristics
- Average age 67 years
- Spondylolisthesis present (defined as ≥ 3 mm slippage) - 55%
- Average slippage in patients with spondylolisthesis - 7.4 mm
- Average ODI score - 42
Randomized treatment groups
- Group 1 (123 patients) - Surgical decompressive laminectomy + spinal fusion
- Group 2 (124 patients) - Surgical decompressive laminectomy
- The surgical method used was left to the discretion of the treating physician
- Patients were not blinded to the procedure they received
- Patients were stratified based on the presence of spondylolisthesis
- The primary analysis was a per-protocol analysis. Ten patients in the fusion group did not receive fusion and were not counted. Four patients in the laminectomy group did not receive laminectomy and were not counted. Five patients were lost to follow-up and not counted.
- Patients included in the final analysis: Group 1 - 111, Group 2 - 117
Primary outcome: Score on the Oswestry Disability Index (ODI) score (range 0 - 100, lower scores
indicate less severe symptoms) at 2 years. Analysis was per-protocol.
Results
Duration: 2 years | |||
Outcome | Fusion | No fusion | Comparisons |
---|---|---|---|
Primary outcome (absence of spondylolisthesis) | 29 | 27 | p=0.70 |
Primary outcome (spondylolisthesis present) | 25 | 21 | p=0.11 |
Average length of hospital stay | 7.4 days | 4.1 days | p<0.001 |
|
Findings: Among patients with lumbar spinal stenosis, with or without degenerative spondylolisthesis, decompression surgery plus fusion surgery did not result in better clinical outcomes at 2 years and 5 years than did decompression surgery alone.
RCT
SLIP trial - Laminectomy + Fusion vs Laminectomy Alone in Spinal Stenosis with Spondylolisthesis, NEJM (2016) [PubMed abstract]
- The SLIP trial enrolled 66 patients who had spinal stenosis and spondylolisthesis
Main inclusion criteria
- Spondylolisthesis of 3 to 14 mm (Grade I)
- Spinal stenosis
- Neurogenic claudication
Main exclusion criteria
- Lumbar instability on X-ray
- Lumbar instability based on history
- Previous lumbar surgery
Baseline characteristics
- Average age 67 years
- Female sex - 80%
- Average degree of spondylolisthesis ∼ 6.0 mm
- Average SF-36 score - 33
Randomized treatment groups
- Group 1 (35 patients) - Surgical decompressive laminectomy
- Group 2 (31 patients) - Surgical decompressive laminectomy + posterolateral instrumented fusion
- Patients were not blinded to the procedure they received
Primary outcome: Change in the SF-36 physical-component summary score at 2 years after surgery. SF-36 score includes general health
and vitality, physical functioning, role–physical, and bodily pain measures (range 0 - 100 with higher scores indicating better quality of life). The minimal clinically important
difference was predetermined to be 5 points.
Results
Duration: 2 years | |||
Outcome | No fusion | Fusion | Comparisons |
---|---|---|---|
Increase in SF-36 at 2 years | 9.5 | 15.2 | diff 5.7, 95%CI [0.1 to 11.3], p=0.046 |
Increase in SF-36 at 4 years | 7.4 | 14.1 | diff 6.7, 95%CI [1.2 to 12.3], p=0.02 |
Decrease in ODI at 2 years | 17.9 | 26.3 | diff -8.5, 95%CI [-17.5 to 0.5], p=0.06 |
Average length of hospital stay | 2.6 days | 4.2 days | p<0.001 |
Major complications | 2 patients | 1 patient | N/A |
Reoperation after 4 years | 34% | 14% | p=0.05 |
Findings: Among patients with degenerative grade I spondylolisthesis, the addition of lumbar spinal fusion to laminectomy was associated with slightly greater but clinically meaningful improvement in overall physical health-related quality of life than laminectomy alone
RCT
NORDSTEN-DS trial - Decompression + Fusion vs Decompression Alone in Spinal Stenosis with Spondylolisthesis, NEJM (2021) [PubMed abstract]
- The NORDSTEN-DS trial enrolled 267 patients with spinal stenosis and degenerative spondylolisthesis
Main inclusion criteria
- Spinal stenosis
- Degenerative spondylolisthesis (≥ 3 mm) solely at the stenotic level
- Neurogenic claudication or radicular radiating pain in the lower limbs
- No response to ≥ 3 months of conservative treatment
Main exclusion criteria
- Age > 80 years
- Foraminal stenosis of grade 3
- Previous surgery at level of spondylolisthesis
- Former fracture or fusion
- Degenerative scoliosis > 20°
Baseline characteristics
- Average age 66 years
- Female sex - 69%
- Average ODI score - 39
- Spondylolisthesis level L4/L5 - 84%
- Average degree of spondylolisthesis - 7.4 mm
Randomized treatment groups
- Group 1 (133 patients): Decompression surgery alone (No fusion)
- Group 2 (129 patients): Decompression + Fusion (Fusion)
- For patients who were assigned to undergo decompression without fusion, a posterior decompression that preserved the midline structures (supraspinous–interspinous ligament complex) was used
- For patients who were assigned to undergo decompression + fusion, an optional technique for posterior decompression (with or without preservation of midline structures) was used, followed by implantation of pedicle screws with rods and bone grafting across the level of spondylolisthesis, with optional use of an intervertebral fusion device
Primary outcome: Reduction in the score on the Oswestry Disability Index (ODI), version 2.0, of 30% or greater from baseline to 2-year follow-up. The ODI comprises 10 questions with a total score ranging from 0 (no impairment)
to 100 (maximum impairment).
Results
Duration: 2 years | |||
Outcome | No fusion | Fusion | Comparisons |
---|---|---|---|
Primary outcome | -20.6 | -21.3 | diff 0.7, 95%CI [-2.8 to 4.3] |
Reoperation | 12.5% | 9.1% | diff 3.4%, 95%CI [-4.6 to 11.5] |
|
Findings: In this trial involving patients who underwent surgery for degenerative lumbar
spondylolisthesis, most of whom had symptoms for more than a year, decompression alone was noninferior to decompression with instrumented fusion over a period of 2 years. Reoperation occurred somewhat more often in the decompression alone group than in the fusion group.
RCT
LESS trial - Epidural Steroid + Lidocaine Injections vs Lidocaine Injections for Spinal Stenosis, NEJM (2014) [PubMed abstract]
- The LESS trial enrolled 400 patients with lumbar spinal stenosis and moderate-to-severe leg pain and disability
Main inclusion criteria
- ≥ 50 years old
- Lumbar spinal stenosis on MRI or CT
- Pain rating of ≥ 5 (scale 0 - 10 with 10 the worst)
Main exclusion criteria
- Spondylolisthesis requiring surgery
- History of lumbar surgery
Baseline characteristics
- Average age 68 years
- Average BMI 30
- Average RMDQ score - 15.9
- Average leg pain score - 7.2
Randomized treatment groups
- Group 1 (200 patients): Fluoroscopic-guided spinal epidural injection of glucocorticoid + lidocaine
- Group 2 (200 patients): Fluoroscopic-guided spinal epidural injection of lidocaine
- Interlaminar (282 patients) or transforaminal (118 patients) approaches were allowed
- Patients could receive a repeat injection at 3 weeks if they wished (about 39% in each group did)
Primary outcome: Difference in the change from baseline in the Roland–Morris Disability Questionnaire (RMDQ, in which scores range from 0 to 24, with higher scores indicating greater physical disability)
and the rating of the intensity of leg pain (on a scale from 0 to 10 with 0 being no pain and 10 being worst pain) at six weeks
Results
Duration: 6 weeks | |||
Outcome | Steroid+Lido | Lidocaine | Comparisons |
---|---|---|---|
Decrease in RMDQ score (6 weeks) | 4.2 | 3.1 | diff -1.0, 95%CI [-2.1 to 0.1], p=0.07 |
Decrease in leg pain score (6 weeks) | 2.8 | 2.6 | diff -0.2, 95%CI [-0.8 to 0.4], p=0.48 |
Decrease in RMDQ score (3 weeks) | 4.4 | 2.6 | diff -1.8, 95%CI [-2.8 to -0.9], p<0.001 |
Decrease in leg pain score (3 weeks) | 2.9 | 2.2 | diff -0.6, 95%CI [-1.2 to -0.1], p=0.02 |
Adverse events | 21.5% | 15.5% | p=0.08 |
|
Findings: In the treatment of lumbar spinal stenosis, epidural injection of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injection of lidocaine alone
- RCTSpinal Cord Burst Stimulation vs Placebo Stimulation for Chronic Radicular Pain, JAMA (2022) [PubMed abstract]
- Design: Randomized, placebo-controlled, crossover trial (N=50 | length = 12 months) in patients with ≥ 6 months of radicular pain (average ≥ 5 on 10 point scale) after ≥ 1 decompressive or fusion procedure(s) for degenerative lumbar spine disease
- Treatment: All patients were implanted with a pulse generator connected to electrodes with leads that travel into the epidural space posterior to the spinal cord dorsal columns. Patients then received two 3-month periods of spinal cord burst stimulation and two 3-month periods of placebo stimulation in random order.
- Primary outcome: Change from baseline in the self-reported Oswestry Disability Index (ODI; range, 0 points [no disability] to 100 points [maximum disability]; the minimal clinically important difference was 10 points) score between periods with burst stimulation and placebo stimulation.
- Results:
- Mean baseline ODI score was 44.7
- Primary outcome (change in ODI): Stimulation periods -10.6, Placebo periods -9.3 (p=0.32)
- Findings: Among patients with chronic radicular pain after lumbar spine surgery, spinal cord burst stimulation, compared with placebo stimulation, after placement of a spinal cord stimulator resulted in no significant difference in the change from baseline in self-reported back pain–related disability.
- Summary
- Surgery vs conservative treatment - the SPORT trial had too many crossovers to draw meaningful conclusions. The much smaller Spine study, which had few crossovers, found that surgery was superior to conservative therapy for pain and disability over two years.
- Laminectomy/decompression +/- fusion - the SLIP trial (N=66) found a small improvement with the addition of spinal fusion to decompressive surgery. The larger SSS Study and NORDSTEN-DS trial found no additional benefit with fusion. Overall, spinal fusion does not appear to enhance decompressive surgery, even in patients with significant spondylolisthesis.
- Epidural steroids - after six weeks, epidural injection of steroid and lidocaine was not superior to lidocaine only in the LESS trial. Steroid was significantly better at three weeks, which may be related to systemic absorption and unrelated to placement around the spinal cord; suppressed cortisol levels, which were observed in the steroid group, support this assumption. Given the cost and potential risk of such procedures (e.g., the deadly meningitis outbreak of 2012), steroid epidural injections should not be given for spinal stenosis. The BMJ 2025 spine procedure guidelines do not recommend epidural injections for radicular or axial spine pain.
- Spinal cord stimulators - spinal cord stimulators have become more popular in recent years, and pain management doctors often promote them. The stimulator study found they did not improve radicular pain after spinal decompression surgery.
TREATMENT | Vertebral compression fractures
- Overview
- Most vertebral compression fractures are treated conservatively with pain medications and short periods of bed rest. Rarely, fractures may cause focal neurologic symptoms and spinal instability requiring surgery. Vertebroplasty, a procedure where an acrylic cement is injected through a needle into the compressed vertebra to stabilize the fracture, is sometimes performed for pain control. A variant of vertebroplasty called balloon kyphoplasty uses an inflatable balloon to heighten the vertebrae before the cement is injected. Early on, many unblinded studies comparing vertebroplasty to conservative treatment found it improved pain. However, blinded studies comparing it to a sham procedure, including the three reviewed below, have not shown a definitive benefit.
RCT
Vertebroplasty vs Sham Procedure for Vertebral Compression Fractures, NEJM (2009) [PubMed abstract]
- A trial in the NEJM enrolled 78 patients with unhealed osteoporotic compression fractures and symptoms for less than 12 months
Main inclusion criteria
- Presence of back pain for ≤ 12 months
- Presence of one or two recent vertebral fractures
- Vertebral compression fracture on MRI with bone edema
Main exclusion criteria
- > 2 recent vertebral fractures
- Previous vertebroplasty
- Spinal cancer
- Neurological complications
- Osteoporotic vertebral collapse of greater than 90%
- Bony fragments impinging on the spinal cord
- Fracture through or destruction of the posterior wall
Baseline characteristics
- Average age 76 years
- Median duration of back pain - 9.25 weeks
- Previous fracture - 50%
- Average pain score - 7.2
- Fracture severity: Mild - 27% | Moderate - 49% | Severe - 24%
Randomized treatment groups
- Group 1 (38 patients) - Vertebroplasty
- Group 2 (40 patients) - Sham vertebroplasty
Primary outcome: Change in overall pain (over the course of the previous week) at 3 months. Pain was measured on a scale
of 0 to 10, with 10 being the maximum imaginable pain and 0 being no pain.
Results
Duration: 6 months | |||
Outcome | Vertebroplasty | Sham | Comparisons |
---|---|---|---|
Decrease in pain score at 3 months | 2.6 | 1.9 | adjusted diff 0.6, 95%CI [−0.7 to 1.8] |
Decrease in pain score at 1 month | 2.3 | 1.7 | adjusted diff 0.5, 95%CI [−0.8 to 1.7] |
Decrease in pain score at 6 months | 2.4 | 2.1 | adjusted diff 0.1, 95%CI [−1.2 to 1.4] |
|
Findings: We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment
RCT
VAPOUR Trial - Vertebroplasty vs Sham Procedure for Vertebral Compression Fractures, Lancet (2016) [PubMed abstract]
- The VAPOUR trial enrolled 120 patients with one or two osteoporotic vertebral fractures that were less than 6 weeks old
Main inclusion criteria
- Age > 60 years
- Back pain for < 6 weeks
- Pain score (0 - 10) of ≥ 7
- MRI or CT confirmed fracture(s)
Main exclusion criteria
- Chronic back pain requiring opiates
- Substantial fracture retropulsion
- Neurological complications
- More than 2 fractures
Baseline characteristics
- Average age 80 years
- Average duration of fracture - 2.6 weeks
- Average pain score - 8.6
- Fracture severity: Mild - 10% | Moderate - 20% | Severe - 70%
- Number of fractures treated: One - 86% | Two - 13%
- Fracture site: T4-T10 - 29% | T11-L2 - 61% | L3-L5 - 15%
Randomized treatment groups
- Group 1 (61 patients) - Vertebroplasty
- Group 2 (59 patients) - Sham vertebroplasty
Primary outcome: Proportion of patients achieving a numeric rated scale (NRS) pain score of < 4 on Day 14 after the intervention. The NRS
pain scale runs from 0 - 10 with 0 being no pain and 10 being maximum pain.
Results
Duration: 6 months | |||
Outcome | Vertebroplasty | Sham | Comparisons |
---|---|---|---|
Primary outcome (day 14) | 44% | 21% | diff 23%, 95%CI [6 - 39], p=0.011 |
Primary outcome (1 month) | 51% | 18% | diff 33%, 95%CI [17 - 50], p=0.0002 |
Primary outcome (3 months) | 55% | 33% | diff 22%, 95%CI [4 - 41], p=0.023 |
Primary outcome (6 months) | 69% | 47% | diff 22%, 95%CI [3 - 40], p=0.027 |
|
Findings: Vertebroplasty is superior to placebo intervention for pain reduction in patients with acute osteoporotic spinal fractures of less than 6 weeks' in duration. These findings will allow patients with acute painful fractures to have an additional means of pain management that is known to be effective.
RCT
VERTOS IV - Vertebroplasty vs Sham Procedure for Acute Vertebral Compression Fracture, BMJ (2018)
[PubMed abstract]
- The VERTOS IV trial enrolled 180 patients with osteoporotic vertebral fractures and pain for less than 9 weeks
Main inclusion criteria
- Age ≥ 50 years
- 1 - 3 vertebral compression fractures
- Pain for up to 6 weeks
- Pain score (0 - 10) ≥ 5
- T-score ≤ -1 on DEXA
- ≥ 15% vertebral height loss
- Bone edema on MRI
Main exclusion criteria
- Severe cardiopulmonary morbidity
- Suspected malignancy
- Untreated coagulopathy
Baseline characteristics
- Average age - 75 years
- Median # of days with back pain until procedure - 40
- Median # of days since fracture diagnosis until procedure - 12
- Multiple fractures treated - 23%
- Average pain score (0 - 10) - 7.8
- Fracture type: Mild - 30% | Moderate - 44% | Severe - 25%
Randomized treatment groups
- Group 1 (90 patients): Vertebroplasty
- Group 2 (86 patients): Sham vertebroplasty
Primary outcome: Mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months
Results
Duration: 12 months | |||
Outcome | Vertebroplasty | Sham | Comparisons |
---|---|---|---|
Average VAS score (1 day) | 5.24 | 4.82 | diff –0.43 (–1.17 to 0.31) |
Average VAS score (1 week) | 4.38 | 4.27 | diff –0.11 (–0.85 to 0.63) |
Average VAS score (1 month) | 3.32 | 3.73 | diff 0.41 (–0.33 to 1.15) |
Average VAS score (3 months) | 2.69 | 2.90 | diff 0.21 (–0.54 to 0.96) |
Average VAS score (6 months) | 3.02 | 3.41 | diff 0.39 (–0.37 to 1.15) |
Average VAS score (12 months) | 2.72 | 3.17 | diff 0.45 (–0.37 to 1.24) |
Findings: Percutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months’ follow-up among patients with acute osteoporotic vertebral compression fractures
- Bracing
- Hard and soft bracing are sometimes used to treat compression fractures. A small study (N=60) found hard and soft bracing did not improve outcomes in patients with osteoporotic compression fractures. [PMID 25471910]
- Summary
- The VAPOUR trial found a benefit with vertebroplasty, while the other two did not. One hypothesis for the conflicting results is that most subjects in the VAPOUR trial were treated within three weeks of fracture diagnosis, while the length between fracture and treatment was longer in the negative trials. The authors of the VERTOS trial also note that more than 80% of participants in the VERTOS sham group believed they had received the intervention compared to 54% in the VAPOUR trial. These differences in placebo effect may have contributed to the contradictory results.
- In conclusion, vertebroplasty may be of some benefit in patients with acute fractures (< 3 weeks), but its effects are not overwhelming
TREATMENT | TENS units
- Overview
- Transcutaneous electrical nerve stimulation (TENS) units are placed over the lower back where they deliver a mild electrical current via skin electrodes. A study comparing TENS units to sham units in people with chronic LBP (see below) found they had no effect on functional status. Another study published in 1990 found they did not improve back pain. [PMID 2140432]
RCT
TENS vs Sham TENS for Chronic Low Back Pain, European Journal of Pain (2011) [PubMed abstract]
- A trial in The European Journal of Pain enrolled 236 patients who had consulted a pain center during the previous week for chronic LBP
Main inclusion criteria
- Chronic LBP (≥ 3 months)
- Pain score (0 - 100) ≥ 40
Main exclusion criteria
- Previous treatment with TENS
- Surgery for radiculopathy within past 3 months
- Bilateral radiculopathy
- Ongoing medical-legal dispute
- Other non-medication treatment planned (e.g. physical therapy)
Baseline characteristics
- Average age 53 years
- Radiculopathy symptoms present - 59%
- Median length of pain - 36.5 months
- Prior surgery for disc disease - 36%
- Median RMDQ score - 15
Randomized treatment groups
- Group 1 (117 patients) - TENS unit
- Group 1 (119 patients) - Sham TENS unit
- The TENS unit was to be applied 4 times a day for 60 minutes for 3 months
- Study treatment was single-blind
Primary outcome: Percent of patients who have improvement of ≥ 4 points on the Roland–Morris Disability Questionnaire (RMDQ) at 6 weeks.
The RMDQ measures functional status and it has a scale of 0 - 24 with higher scores indicating greater disability.
Results
Duration: 6 weeks | |||
Outcome | TENS | Sham TENS | Comparisons |
---|---|---|---|
Primary outcome (6 weeks) | 30% | 24.3% | RR 1.23, 95%CI [0.80 - 1.89], p=0.351 |
Primary outcome (3 months) | 26.4% | 25% | RR 1.05, 95%CI [0.67 - 1.65], p=0.816 |
Median RMDQ score at 6 weeks | 12 | 13 | N/A |
≥ 50% improvement in lumbar pain | 25% | 6.7% | p=0.0003 |
≥ 50% improvement in radicular pain | 33.8% | 15% | p=0.0148 |
Findings: There was no functional benefit of TENS in the treatment of patients with chronic LBP
Treatment | Radiofrequency denervation
- Overview
- It is hypothesized that nonspecific back pain may originate from irritated nerves surrounding intervertebral discs and facet and sacroiliac joints. Radiofrequency denervation (RD) is a procedure where a needle is placed using fluoroscopic or ultrasound guidance in the area of nerve endings thought to be causing pain. The needle is then heated, theorectically killing the pain-conducting nerve. Treatment areas are determined from lidocaine injections that elicit a positive response. The study below found no effect of RD in patients with chronic LBP thought to be related to RD-treatable nerve endings. The study was unblinded, allowing for a placebo effect in the RD group. Even so, RD had no meaningful effect.
RCT
Radiofrequency Denervation vs None for Chronic Low Back Pain, JAMA (2017) [PubMed abstract]
- A study in the JAMA enrolled 681 people with chronic low back pain
Main inclusion criteria
- Age 18 - 70 years
- Pain thought to be from facet joint, sacroiliac joint, and/or intervertebral disc
- No improvement after conservative measures
Main exclusion criteria
- BMI > 35
- Work-related disability claims
- Anticoagulant therapy
- Severe psychological problems
Baseline characteristics
- Average age 51 years
- Average BMI - 27
- Length of LBP ∼ 30 months
- Average pain score - 7.1
Randomized treatment groups
- Group 1 (125 patients): Radiofrequency denervation (RD)
- Group 2 (126 patients): None
- All participants received physical therapy
- RD was performed within one week of the first exercise session. Patients could receive up to 3 treatments.
- Participants with suspected isolated facet joint pain or isolated sacroiliac joint pain received a diagnostic anesthetic block prior to randomization and were only randomized if the diagnostic block was positive
- Participants with a suspected combination of sources of pain were randomized based on participant history and physical examination prior to receiving the diagnostic blocks
- Results were presented in 3 groups based on patient symptoms: facet joint only, sacroiliac joint only, or a combination
Primary outcome: Pain intensity, measured on an 11-point numerical rating scale (NRS; a score of 0 indicates no
pain; 10 indicates worst pain imaginable) 3 months after the intervention. A clinically important difference was defined as ≥ 2 points.
Results
Duration: 12 months | |||
Outcome | RD | None | Comparisons |
---|---|---|---|
Primary outcome (facet joint) | 5.01 | 5.44 | p=0.55 |
Primary outcome (sacroiliac joint) | 4.77 | 5.45 | p=0.03 |
Primary outcome (combination) | 4.77 | 5.94 | p=0.01 |
|
Findings: In 3 randomized clinical trials of participants with chronic low
back pain originating in the facet joints, sacroiliac joints, or a combination of facet joints,
sacroiliac joints, or intervertebral disks, radiofrequency denervation combined with a
standardized exercise program resulted in either no improvement or no clinically important
improvement in chronic low back pain compared with a standardized exercise program alone.
The findings do not support the use of radiofrequency denervation to treat chronic low back
pain from these sources.
BMJ SPINE PROCEDURE RECOMMENDATIONS
- The British Medical Journal (BMJ) published recommendations in 2025 on procedures for chronic (≥ 3 months) spine pain not caused by cancer or an inflammatory arthropathy. [PMID 39971339] The authors included four people living with chronic spine pain, 10 clinicians with experience managing chronic spine pain, and eight methodologists. The evidence reviewed encompassed studies comparing interventions to usual care or sham procedures. Based on their review, the following recommendations were made.
- Axial spine pain: For cervical, lumbar, or sacroiliac axial spine pain, the panel strongly recommends AGAINST the following procedures:
- Joint radiofrequency ablation with or without joint targeted injection of local anesthetic plus steroid
- Epidural injection of local anesthetic, steroids, or their combination
- Joint-targeted injection of local anesthetic, steroids, or their combination
- Intramuscular injection of local anesthetic with or without steroids
- Radicular pain: For cervical or lumbar radicular pain, the panel strongly recommends AGAINST the following procedures:
- Dorsal root ganglion radiofrequency with or without epidural injection of local anesthetic or local anesthetic plus steroids
- Epidural injection of local anesthetic, steroids, or their combination
MEDICATIONS FOR LBP
- Nonsteroidal anti-inflammatory drugs (NSAIDs)
- NSAIDs are widely prescribed to help alleviate LBP. In trials, they have been found to be effective. [51]
- Opioids
- Opioids are not generally recommended for acute low back pain, while their use in chronic pain is controversial. A trial (N=347) in patients with acute neck and/or low back pain found that oxycodone was no better than placebo for pain relief at 6 weeks. [PMID 37392748] Another study in patients given naproxen for acute nonspecific LBP found that the addition of oxycodone was no better than placebo or cyclobenzaprine for functional status at one week. [PMID 26501533]
- Acetaminophen (Tylenol®)
- Acetaminophen is widely available and often used to treat LBP. A large trial (N=1652) in patients with acute LBP found that it did not shorten recovery time compared to placebo. [PMID 25064594]
- Muscle relaxants
- Carisoprodol (Soma®)
- Carisoprodol, a controlled substance that has abuse potential, has been shown to be effective for LBP in trials [54]
- Cyclobenzaprine (Flexeril®)
- In trials, cyclobenzaprine's effects on LBP have been mixed. A meta-analysis found that it had a modest short-term benefit compared to placebo. [PMID 11434793] A study in patients given naproxen for acute nonspecific LBP found that the addition of cyclobenzaprine was no better than placebo or oxycodone for functional status at one week. [PMID 26501533]
- Metaxalone (Skelaxin®)
- A study comparing the addition of metaxalone, baclofen, tizanidine, or placebo to ibuprofen in patients presenting to the ER with acute nonspecific LBP found none of the drugs were significantly better than placebo. See muscle relaxer study for more.
- Methocarbamol (Robaxin®)
- A study comparing the addition of methocarbamol, orphenadrine, or placebo to naprosyn in patients presenting to the ER with nonspecific LBP found that neither muscle relaxer improved outcomes compared to placebo. See orphenadrine vs methocarbamol for LBP for more.
- Tizanidine (Zanaflex®)
- A study comparing the addition of tizanidine, metaxalone, baclofen, or placebo to ibuprofen in patients presenting to the ER with acute nonspecific LBP found none of the drugs were significantly better than placebo. See muscle relaxer study for more.
- Benzodiazepines
- A study comparing the addition of valium or placebo to naproxen in patients presenting to the ER with acute nonspecific LBP found that valium was no better than placebo at improving pain and function over 3 months of follow-up. [PMID 28187918]
RCT
Gabapentin vs Epidural Steroid Injections for Sciatica, BMJ (2015) [PubMed abstract]
- A study in the BMJ enrolled 145 patients at military treatment facilities with radicular leg pain (sciatica) from either a herniated disc or spinal stenosis
Main inclusion criteria
- Leg pain score ≥ 4/10 or 3/10 if the leg pain ≥ back pain
- Symptoms for > 6 weeks and < 4 years
- MRI findings of herniated disc or spinal stenosis
Main exclusion criteria
- Previous failed therapy with gabapentin or pregabalin
- Epidural steroid injection within last 3 years
- Neurogenic claudication
- Previous lumbar surgery
- Active litigation
- Psychiatric illness
Baseline characteristics
- Average age 42 years
- Herniated disc ∼ 87.5% | Spinal stenosis ∼ 12.5%
- Symptoms for > 3 months ∼ 82%
- Treatment with opioids - 16%
- Average pain score - 5.4
- Transforaminal injection approach ∼ 84%
Randomized treatment groups
- Group 1 (73 patients) - Epidural steroid injection (60 mg methylprednisolone + 1 mL of 0.25% bupivacaine) + placebo pills
- Group 2 (72 patients) - Sham injection + gabapentin (target dose 1800 - 3600 mg/day)
- Gabapentin was dosed 3 times a day and titrated over 15 - 24 days
- Tramadol and NSAIDs could be prescribed on an "as needed" basis as rescue medications (or opioids could be increased by up to 20% for those taking opioids), but no other co-interventions were permitted
- Patients with a negative outcome at one month left the study and were not included in the 3 month follow-up
Primary outcome: Average change from baseline on a leg pain score (scale 0 - 10 with 0 indicating no pain and 10 worst pain) at one and three months. Score reflects the average pain
experienced during the week before follow-up.
Results
Duration: 3 months | |||
Outcome | Epidural | Gabapentin | Comparisons |
---|---|---|---|
Decrease in leg pain score (one month) | 2.2 | 1.7 | diff 0.4, 95%CI [−0.3 to 1.2], p=0.25 |
Decrease in leg pain score (three months) | 2.0 | 1.6 | diff 0.3, 95%CI [−0.5 to 1.2], p=0.43 |
|
Findings: Although epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people
- RCTPregabalin vs Placebo for Acute and Chronic Sciatica, NEJM (2017) [PubMed abstract]
- Design: Randomized placebo-controlled trial (N=209 | length = 8 weeks) in patients with sciatica for at least 1 week and less than 1 year
- Treatment: Pregabalin titrated to a maximum of 600 mg/day vs Placebo for 8 weeks
- Primary outcome: Leg-pain intensity score on a 10-point scale (with 0 indicating no pain and 10 the worst possible pain) at 8 weeks
- Results:
- Primary outcome: Pregabalin - 3.7, Placebo - 3.1 (p=0.19)
- Findings: Treatment with pregabalin did not significantly reduce the intensity of leg pain associated with sciatica and did not significantly improve other outcomes, as compared with placebo, over the course of 8 weeks. The incidence of adverse events was significantly higher in the pregabalin group than in the placebo group.
- RCTPregabalin vs Diphenhydramine for Neurogenic Claudication in Spinal Stenosis, Neurology (2015) [PubMed abstract]
- Design: Randomized controlled crossover trial (N=29 | length = 33 days) in patients with spinal stenosis and neurogenic claudication
- Treatment: Pregabalin 150 mg twice daily vs Diphenhydramine 12.5 mg twice daily. Patients received each treatment for 13 days before crossing over to the other treatment with a 7 day washout period in between.
- Primary outcome: Time to first moderate pain symptom (Numeric Rating Scale (0 - 10) score ≥ 4) during a 15-minute treadmill test
- Results:
- Primary outcome: No significant difference was found between pregabalin and active placebo for the time to first moderate pain symptom (p=0.61)
- Findings: Pregabalin was not more effective than active placebo in reducing painful symptoms or functional limitations in patients with neurogenic claudication associated with lumbar spinal stenosis
RCT
Duloxetine vs Placebo for Nonspecific LBP, The Journal of Pain (2010) [PubMed abstract]
- A trial in the The Journal of Pain enrolled 401 patients with chronic LBP
Main inclusion criteria
- Pain restricted to the low back or with radiation to proximal lower limb only
- Pain present on most days for ≥ 6 months
Main exclusion criteria
- Findings of radiculopathy or spinal stenosis
- Grade 3 or 4 spondylolisthesis
- > 1 back surgery and 1 occurring within 12 months
- Active disability claim or back-related litigation
- Serious psychiatric diagnosis
- BMI > 40
Baseline characteristics
- Average age 54 years
- Average duration of LBP - 8.5 years
- Female sex - 61%
- Average weight - 173 lbs
- Average BPI 24-hour pain score - 5.80
Randomized treatment groups
- Group 1 (203 patients) - Placebo once daily for 12 weeks
- Group 2 (198 patients) - Duloxetine 60 mg once daily for 12 weeks
- Patients were allowed to use ibuprofen, acetaminophen, or naproxen as needed for up to 3 consecutive days and no more than 20 total days
Primary outcome: Reduction in pain severity as measured by the Brief Pain Inventory (BPI) 24-hour average pain ratings. The BPI
24-hour average pain rating is a scale that ranges from 0 (no pain) to 10 (worst possible pain).
Results
Duration: 12 weeks | |||
Outcome | Placebo | Duloxetine | Comparisons |
---|---|---|---|
Primary outcome (decrease in BPI) | 1.75 | 2.4 | p<0.001 |
Drug discontinuation due to side effects | 5.4% | 15.2% | p=0.002 |
|
Findings: This study provides clinical evidence of the efficacy and safety of duloxetine at a fixed dose of 60 mg once daily in the treatment of chronic
low back pain (CLBP). As of December 2009, duloxetine has not received regulatory approval for the treatment of CLBP.
RCT
Prednisone vs Placebo for Sciatica, JAMA (2015) [PubMed abstract]
- A trial in the JAMA enrolled 269 adults with acute sciatica
Main inclusion criteria
- Pain for ≤ 3 months
- Leg pain extending below the knee in a nerve root distribution
- Herniated disc confirmed by MRI
- ≥ 30 point score on the Oswestry Disability Index (ODI)
Main exclusion criteria
- Previous lumbar surgery
- Oral or epidural steroid treatment in the prior 3 months
- Diabetes
- Substantial or progressive motor loss
- Ongoing litigation or workers compensation claim
Baseline characteristics
- Average age 46 years
- Average time from pain onset to randomization - 30 days
- Positive straight leg raise - 88% of patients
- Average ODI score - 51
Randomized treatment groups
- Group 1 (181 patients) - Prednisone taper (60 mg for 5 days, 40 mg for 5 days, 20 mg for 5 days)
- Group 2 (88 patients) - Placebo
- NSAIDS were not allowed during the 3 weeks after randomization
Primary outcome: Change in score on the Oswestry Disability Index (ODI) at 3 weeks after randomization. ODI is a measure of disability
that has a scale of 0 - 100 with higher scores indicating greater disability.
Results
Duration: 52 weeks | |||
Outcome | Prednisone | Placebo | Comparisons |
---|---|---|---|
Decrease in ODI at 3 weeks | 19 | 13.3 | diff 6.4 points, 95%CI [1.9 to 10.9], p=0.006 |
Decrease in ODI at 52 weeks | 37.8 | 30.4 | diff 7.4 points, 95%CI [2.2 to 12.5], p=0.005 |
Insomnia | 25.7% | 10.2% | p=0.003 |
Nervousness | 18.4% | 8% | p=0.03 |
Increased appetite | 22.3% | 10.2% | p=0.02 |
|
Findings: Among patients with acute radiculopathy due to a herniated lumbar disk, a short course of oral steroids, compared with placebo, resulted in modestly improved function and no improvement in pain.
RCT
Glucosamine vs Placebo for Degenerative Lumbar Osteoarthritis, JAMA (2010) [PubMed abstract]
- A study in the JAMA enrolled 250 patients with chronic LBP and degenerative spine changes on MRI scans
Main inclusion criteria
- Age > 25 years
- Nonspecific chronic LBP for ≥ 6 months
- MRI findings indicating degenerative process
- Score ≥ 3 on the RMDQ
Main exclusion criteria
- Symptomatic intervertebral disc herniation or spinal stenosis
- Previous lumbar surgery or fracture
- Use of glucosamine within 1 year
Baseline characteristics
- Average age 48.5 years
- Average duration of LBP - 13.3 years
- Facet changes on MRI - 62%
- Disc height loss on MRI - 69%
- Average BMI - 25
- Average RMDQ score - 9.5
Randomized treatment groups
- Group 1 (125 patients) - Glucosamine 1500 mg a day for 6 months
- Group 2 (125 patients) - Placebo for 6 months
- Patients were free to use other therapies and medications during the trial (excluding glucosamine during the first 6 months)
- After 6 months, patients could use open-label glucosamine if they chose to do so
Primary outcome: Difference in pain-related disability measured with the Roland Morris Disability Questionnaire (RMDQ) at
6 weeks, 3 months, 6 months, and 1 year. The RMDQ scale goes from 0 - 24 with higher scores indicating greater disability.
Results
Duration: 1 year | |||
Outcome | Glucosamine | Placebo | Comparisons |
---|---|---|---|
Primary outcome (6 weeks) | 7.0 | 7.1 | diff -0.1, 95%CI [-1.3 to 1.0], p=0.82 |
Primary outcome (3 months) | 5.8 | 6.5 | diff -0.7, 95%CI [-1.8 to 0.5], p=0.24 |
Primary outcome (6 months) | 5.0 | 5.0 | diff 0.0, 95%CI [-1.1 to 1.2], p=0.72 |
Primary outcome (1 year) | 4.8 | 5.5 | diff -0.8, 95%CI [-2.0 to 0.4], p=0.50 |
Using other medications for LBP at 6 months | 27.2% | 34.4% | p=0.39 |
|
Findings: Among patients with chronic LBP and degenerative lumbar OA, 6-month treatment with oral glucosamine compared with placebo did not result in reduced pain-related disability after the 6-month intervention and after 1-year follow-up.
SPONDYLOLYSIS AND SPONDYLOLISTHESIS
- Pathology
- Spondylolysis
- Spondylolysis is a fracture(s) in the pars interarticularis, joints that articulate with the adjacent vertebral bodies. In children and young adults, it is believed to be caused by repetitive stress and is seen more frequently in athletes who engage in sports requiring frequent and extensive spine motion (e.g., gymnasts, figure skaters, dancers, divers).
- Spondylolisthesis
- Spondylolisthesis is a condition where one vertebral body is displaced forward in relation to the one below it. There are two types of spondylolisthesis. Degenerative spondylolisthesis occurs when osteoarthritic changes in the pars interarticularis joint create laxity, allowing the vertebral body above to move forward. Spondylolytic spondylolisthesis is caused by stress fractures in the pars interarticularis, which allow slippage (see spondylolisthesis illustration). Younger patients are affected by spondylolytic spondylolisthesis, while older patients typically have degenerative spondylolisthesis. [72,74]
- Spondylolisthesis is expressed as a percentage using the Meyerding method, which takes the anterior-posterior length of the upper vertebra's overhanging part and divides it by the anterior-posterior diameter of the lower vertebra's top surface. The ratio is then multiplied by 100 and expressed as a percent, which can be used to assign a grade as below. [72,74]
- Grade I: ≤ 25%
- Grade II: 26 - 50%
- Grade III: 51 - 75%
- Grade IV: 76 - 100%
- Grade V: 100% (spondyloptosis)
- Spondylolisthesis in children and young adults typically occurs at the L5 - S1 level, and slippage is usually mild, with 79% being Grade I, 20% being Grade II, and 1% being Grade III. Degenerative spondylolisthesis most often affects the L4 - L5 level, with an average slippage of 14%.
- Prevalence
- Children and young adults
- Spondylolysis is present in 4% of 6-year-olds and 6% of 14-year-olds. Spondylolisthesis is not seen in unilateral spondylolysis but is present to some degree in 50 - 74% of patients with bilateral defects.
- Older patients
- A study that reviewed CT scans (N=188) from an unselected population of U.S. adults (average age 52 years) found the following:
- Lumbar spondylolysis was present in 16.5% of males and 5% of females
- Spondylolisthesis was present in 20.7% of patients
- Spondylolytic spondylolisthesis was present in 8.2% of patients
- Degenerative spondylolisthesis was present in 7.7% of men and 21.3% of women
- Prevalence of degenerative spondylolisthesis by age was as follows:
- < 40 years: 0%
- 40 - 49 years: 2.1%
- 50 - 59 years: 10.8%
- 60 - 69 years: 41.7%
- ≥ 70 years: 16.7% [72,73,76]
- Symptoms
- Children and young adults
- Most patients are asymptomatic, while 10% may develop LBP worsened by activity, particularly lumbar hyperextension.
- Older patients
- Most patients are asymptomatic, unless they develop significant spinal stenosis
- Natural course
- Children and young adults
- Most cases of isolated spondylolysis heal spontaneously. Bilateral defects are less likely to heal than unilateral ones, and concomitant spondylolisthesis makes fracture resolution unlikely. Over time, spondylolytic spondylolisthesis rarely progresses, with only 4 - 5% of patients experiencing worsening in longitudinal studies. [72,76]
- Older patients (> 40 years)
- Spondylolisthesis progression is more common in older patients. A study following 145 patients with degenerative spondylolisthesis for 10 years found that the condition progressed in 34% of patients. However, progression did not correlate with increased symptoms, and only 15% of patients were ever treated surgically. [74]
- Treatment
- Children and young adults
- Most patients can be managed conservatively, and those who are asymptomatic (i.e., spondylolysis is discovered incidentally) can continue their current level of physical activity. There is no consensus on how to manage symptomatic patients, with a mix of bracing, activity modification, and physical therapy often being used. Regardless of treatment, prognosis is good, with more than 90% of patients returning to athletic competition. Rarely, surgery may be required for severe cases (e.g., grade 3 or 4 spondylolisthesis, progressive neurologic symptoms). [76]
- Older patients (> 40 years)
- Degenerative spondylolisthesis can cause and/or worsen spinal stenosis. See spinal stenosis treatment for more. [74]
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