LOW BACK PAIN (LBP)





























  • Reference [4]
Prevalence of LBP Causes Seen in Primary Care
Etiology of LBP 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
(ankylosing spondylitis, etc.)
0.3%
All other 6%









Steps to Determining the Cause of LBP
STEP 1 - Categorize LBP into 1 of 3 categories
  • Nonspecific LBP
  • Disc Disease and spinal stenosis
  • Other causes [20]
STEP 2 - Evaluate for disc disease
  • Symptoms
    • Symptoms of disc disease include pain that radiates across the buttocks and down a leg (sciatica). Weakness in the affected leg may also occur.
    • The pain from disc disease may occur suddenly or it may be gradual
  • Physical exam
    • Disc disease may be obvious in some cases, and it may be difficult to detect in others
    • A number of physical exam findings can be used to help determine if disc disease is present
    • The utility of these findings is discussed below - see physical exam tests for disc disease
STEP 3 - If disc disease is suspected, evaluate for spinal stenosis
  • Risks
    • The most important risk factor for spinal stenosis is advanced age (> 60 years old)
    • In younger patients, spinal stenosis will be much less likely
  • Symptoms and physical exam
    • A review in the JAMA evaluated the accuracy of physical exam findings and symptoms in predicting spinal stenosis
    • The review looked at studies where exam findings and symptoms were compared to definitive measures (CT, MRI, etc.)
    • The following findings were most helpful:
      • Neurogenic claudication (pain with walking or standing that is relieved when bending forward) - sensitivity 82%, specificity 78%
      • Absence of pain when seated - sensitivity 47%, specificity 94%
      • Wide-based gait (walking with feet spread apart) - sensitivity 42%, specificity 97%
STEP 4 - In certain patients, consider other causes of back pain
  • Elderly, frail patients with osteoporosis - consider vertebral compression fractures
  • Cancer history - consider cancer recurrence or metastasis to the spine
  • Younger patients with decreased range of motion and stiffness - consider ankylosing spondylitis
  • Bowel and bladder symptoms - consider cauda equina syndrome
  • Fever and/or IV drug user - consider infection











  • Reference [22]
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%

  • Reference [23]
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%


  • Average age of the cohort was 45 years
  • Reference [40]
Natural Course of Disc Disease over 14 Months in 154 Symptomatic Patients
Finding Improved Unchanged Worse
Bulging disc 21% 67% 12%
Broad-based disc protrusion 80% 20% 0%
Focal disc protrusion 65% 23% 12%
Disc extrusion 78% 14% 8%
Disc sequestration 75% 25% 0%













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 < 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
  • There was no significant difference in pain scores at any time point

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.






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]
  • At two years, 45% of patients assigned to the nonoperative group had received surgery
  • At two years, 40% of patients assigned to the surgery group had not received surgery
  • Surgical complications occurred in 5% of patients and were typically minor

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
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]
  • Patients in the discectomy group underwent surgery at an average of 2.2 weeks from randomization
  • At one year, 39% of patients assigned to conservative treatment had received surgery. These patients received surgery at an average of 18.7 weeks.
  • At one year, 11% of patients assigned to the surgery group had not received surgery
  • Surgical complications occurred in 1.6% of all surgical patients [32]

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.
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
  • For the Sham group, the average change in the ODI was -4.7 at 6 weeks, -11.4 at 12 weeks, and -14.3 at 52 weeks
  • Saline minus Sham ODI score differences were as follows: -0.5 at 6 weeks, +1.4 at 12 weeks, and -1.9 at 52 weeks (all nonsignificant)
  • Steroid minus Sham ODI score differences were as follows: -2.9 at 6 weeks, +4.0 at 12 weeks, and +1.9 at 52 weeks (all nonsignificant)
  • None of the comparisons at any time point were statistically significant. Analyses were adjusted for differences in baseline values.
  • Analyses adjusted for duration of leg pain, back pain, and sick leave were also nonsignificant
  • There were no serious complications from the injections

Findings: Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy





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]
  • At two years, 43% of patients assigned to conservative treatment had received surgery
  • At two years, 33% of patients assigned to the surgery group had not received surgery
  • In patients who received surgery, 11% also had a fusion performed. Intraoperative and postoperative complications occurred in 9% and 12% of patients, respectively. [35]

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
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]
  • In the surgery group, ten patients received lumbar fusion. Nine of these patients had degenerative spondylolisthesis.
  • At two years, walking distance had improved significantly in both groups and there was no significant difference between the groups
  • Measures of leg pain and low back pain were significantly better in the surgical group throughout the trial
  • At two years, 9% of patients assigned to the conservative therapy had received surgery
  • At two years, 8% of patients assigned to the surgery group had not received surgery
  • There were 8 operative complications and 4 postoperative complications in the patients treated with surgery. None led to morbidity or mortality. [36]

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.
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
  • There was no significant difference between the groups for measures of leg and back pain and the 6-minute walk test
  • 138 patients completed 5 years of follow-up. There was no significant difference between the groups for the ODI score at 5 years (Group 1 - 27, Group 2 - 28, p=0.86).
  • After an average follow-up of 6.5 years, 22% of patients in the fusion had undergone additional lumbar spine surgery compared to 21% in the No Fusion group
  • Surgical complications were similar between the groups

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
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
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
  • Serious adverse events requiring hospitalization and/or surgery occurred in 5 patients in the Steroid group and 4 patients in the Sham group
  • Morning cortisol suppression (< 10 mcg/dl) was significantly greater in the Steroid group than in the Sham group at 3 weeks (60% vs 42%) and 6 weeks (53% vs 38%)

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





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]
  • There was no significant difference between groups in other outcomes including pain at night, pain at rest, physical functioning, quality of life, and perceived improvement
  • 82% of participants had one vertebral body treated and 18% had two treated
  • Adverse events were generally minor and did not differ between groups [38]

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
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
  • Improvement in function as measured by the Roland-Morris Disability Questionnaire was significantly better in the vertebroplasty group at 1, 3, and 6 months
  • In subgroup analysis, patients with non-thoracolumbar fractures and patients with fractures > 3 weeks old did not have a significant benefit from vertebroplasty at Day 14
  • There were no significant adverse events related to the procedure
  • At Day 14, 54% of patients in the control group correctly guessed that they had received a sham procedure while 80% of the vertebroplasty group correctly guessed that they had received the procedure

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.
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






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





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
  • At 6, 9, and 12 months, there was no significant difference in pain scores between the groups

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.











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
  • At one month, 23 patients in the epidural group had a negative outcome and left the study compared to 39 patients in the gabapentin group
  • Within one year of enrollment, 13% of patients in the epidural group proceeded to surgery compared to 15% in the gabapentin group (p=0.73)
  • There was no significant difference in adverse events

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







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
  • Nausea, dizziness, and dry mouth were reported significantly more in the duloxetine group

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.





Prednisone taper 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
  • There was no significant difference in pain (measured with a 10-point scale: 0 none, 10 worst) between groups at 3 and 52 weeks
  • In the prednisone group, 75% of subjects correctly identified their randomization group compared to 53% in the placebo group (p=0.001)

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.





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
  • There was no significant difference in adverse events between the groups

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.