Objective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of d

http://www.immpact.org/static/publications/Turk%20et%20al.,%202003.pdf

Core outcome domains for chronic pain clinical trials: IMMPACT recommendations.

Interpreting the Clinical Importance of Treatment Outcomes in Chronic Pain Clinical Trials: IMMPACT Recommendations

http://www.immpact.org/static/publications/Dworkin%20et%20al.,%202005.pdf

Topical Review and RecommendationsCore outcome measures for chronic pain clinical trials: IMMPACT recommendations

Recommendation 1: Clinicians should conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories: nonspecific low back pain, back pain potentially associated with radiculopathy or spinal stenosis, or back pain potentially associated with another specific spinal cause. The history should include assessment of psychosocial risk factors, which predict risk for chronic disabling back pain (strong recommendation, moderate-quality evidence). Recommendation 2: Clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain (strong recommendation, moderate-quality evidence). Recommendation 3: Clinicians should perform diagnostic imaging and testing for patients with low back pain when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination (strong recommendation, moderate-quality evidence). Recommendation 4: Clinicians should evaluate patients with persistent low back pain and signs or symptoms of radiculopathy or spinal stenosis with magnetic resonance imaging (preferred) or computed tomography only if they are potential candidates for surgery or epidural steroid injection (for suspected radiculopathy) (strong recommendation, moderate-quality evidence). Recommendation 5: Clinicians should provide patients with evidence-based information on low back pain with regard to their expected course, advise patients to remain active, and provide information about effective self-care options (strong recommendation, moderate-quality evidence). Recommendation 6: For patients with low back pain, clinicians should consider the use of medications with proven benefits in conjunction with back care information and self-care. Clinicians should assess severity of baseline pain and functional deficits, potential benefits, risks, and relative lack of long-term efficacy and safety data before initiating therapy (strong recommendation, moderate-quality evidence). For most patients, first-line medication options are acetaminophen or nonsteroidal anti-inflammatory drugs. Recommendation 7: For patients who do not improve with selfcare options, clinicians should consider the addition of nonpharmacologic therapy with proven benefits—for acute low back pain, spinal manipulation; for chronic or subacute low back pain, intensive interdisciplinary rehabilitation, exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy, or progressive relaxation (weak recommendation, moderate-quality evidence).

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Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society

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Chapter 4. European guidelines for the management of chronic nonspecific low back pain.

STUDY DESIGN A randomized controlled multicenter study with a 2-year follow-up by an independent observer. OBJECTIVES To determine whether fusion of the lower lumbar spine could reduce pain and diminish disability more effectively when compared with nonsurgical treatment in patients with severe chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA The reported results after fusion surgery on patients with CLBP vary considerably, and the evidence of treatment efficacy is weak in the absence of randomized controlled studies. PATIENTS AND METHODS A total of 294 patients referred to 19 spinal centers from 1992 through 1998 were randomized blindly into four treatment groups. Patients aged 25-65 years with CLBP for at least 2 years and with radiologic evidence of disc degeneration at L4-L5, L5-S1, or both were eligible to participate in the study. The surgical group (n=222) included three different fusion techniques, not analyzed separately in this study. Patients in the nonsurgical group (n=72) were treated with different kinds of physical therapy. The surgical group comprised 49.5% men, and the mean age was 43 years. The corresponding figures for the nonsurgical group were 48.6% and 44 years. The patients had suffered from low back pain for a mean of 7.8 and 8.5 years and been on sick leave due to back pain for a mean of 3.2 and 2.9 years, respectively. The Visual Analogue Scale (VAS) was used to measure pain. The Oswestry Low Back Pain Questionnaire, the Million Score and the General Function Score (GFS) were used to measure disability. The Zung Depression Scale was used to measure depressive symptoms. The overall result was assessed by the patient and by an independent observer. Records from the Swedish Social Insurance were used to evaluate work disability. Patients who changed groups were included in the analyses of significance according to the intention-to-treat principle. RESULTS At the 2-year follow-up 289 of 294 (98%) patients, including 25 who had changed groups, were examined. Back pain was reduced in the surgical group by 33% (64 to 43), compared with 7% (63 to 58) in the nonsurgical group (P=0.0002). Pain improved most during the first 6 months and then gradually deteriorated. Disability according to Oswestry was reduced by 25% (47 to 36) compared with 6% (48 to 46) among nonsurgical patients (P=0.015), according to Million by 28% (64 to 46) compared with 8% (66 to 60) (P=0.004), and accordingtoGFS by 31% (49 to 34) compared with 4% (48 to 46) (P=0.005). The depressive symptoms, according to Zung, were reduced by 20% (39 to 31) in the surgical group compared with 7% (39 to 36) in the nonsurgical group (P=0.123). In the surgical group 63% (122/195) rated themselves as "much better" or "better" compared with 29% (18/62) in the nonsurgical group (P<0.0001). The "net back to work rate" was significantly in favor of surgical treatment, or 36% vs. 13% (P=0.002). The early complication rate in the surgical group was 17%. CONCLUSION Lumbar fusion in a well-informed and selected group of patients with severe CLBP can diminish pain and decrease disability more efficiently than commonly used nonsurgical treatment.

2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group.

When measuring treatment effect in chronic low back pain with multi-item outcome instruments, it is necessary, both for clinical decision-making and research purposes, to understand the clinical importance of the outcome scores. The aims of the present study were three-fold. Firstly, it aimed to estimate the minimal clinically important difference of three multi-item outcome instruments (the Oswestry Disability Index, the General Function Score and the Zung Depression Scale) and of the visual analogue scale (VAS) of back pain. Secondly, it aimed to estimate the error of measurement of these instruments; and its third aim was to describe the clinical meaning of score change. The study population consisted of 289 patients treated surgically or non-surgically in a randomised controlled trial. The minimal clinically important difference was estimated with patient global assessment as the external criterion. It was compared with the standard error of measurement of the instruments. The individual items of the instruments were compared for score changes related to improvement and deterioration. The standard error of measurement of the Oswestry Disability Index, the General Function Score and the Zung Depression Scale was 4, 6 and 3 units, respectively. The 95% tolerance interval was 10, 16 and 8 units, respectively. The minimal clinically important difference was 10, 12 and 8–9 units, respectively, thus not significantly exceeding the tolerance interval. The minimal clinically important difference of VAS back pain was 18–19 units, well exceeding the 95% tolerance interval, which was 15 units. Improvement after treatment for chronic low back pain tends to occur to a greater extent in sleep disturbance, ability to do usual things and psychological irritability, but to a lesser extent in the ability to sit, stand and lift. We conclude that the VAS of back pain is responsive enough to detect the minimal clinically important difference, whereas the smallest acceptable score changes of the Oswestry Disability Index, the General Function Score and the Zung Depression Scale may require an increase to exceed the 95% tolerance interval when used for clinical decision making and for power calculation. Despite improvement after treatment, the ability to sit, stand and lift, remain notable problems.

The clinical importance of changes in outcome scores after treatment for chronic low back pain

Study design A multicenter randomized study with a 2-year follow-up period and an independent observer was conducted. Objective To compare three commonly used surgical techniques to achieve lumbar fusion primarily in terms of their ability to reduce pain and decrease disability in patients with severe chronic low back pain. Summary of background data Lumbar fusion can be used to reduce pain and decrease disability in patients with chronic low back pain, and different surgical techniques are available. The reported results after fusion surgery vary considerably, but most studies are retrospective and/or performed on heterogeneous patient groups. Spine surgeons commonly use the techniques presented in this report. However, in the absence of randomized trials it is difficult to know whether any one of them is better than the others for these patients. Methods From 1992 through 1998, 294 patients referred to 19 spinal centers were blindly randomized into four treatment groups: three surgical groups (n = 222) and one nonsurgical group (n = 72). The sociodemographic and clinical characteristics did not differ among the groups. Eligibility included patients 25 to 65 years of age with therapy-resistant chronic low back pain that had persisted for at least 2 years and radiologic evidence of disc degeneration (spondylosis) at L4-L5, L5-S1, or both. Only patients randomized to one of three surgical groups were analyzed in the current study: Group 1 (posterolateral fusion; n = 73), Group 2 (posterolateral fusion combined with variable screw placement, an internal fixation device; n = 74), and Group 3 (posterolateral fusion combined with variable screw placement and interbody fusion; n = 75). The "circumferential fusion" in Group 3 was performed either as an anterior lumbar interbody fusion (n = 56) or as a biomechanically similar posterior lumbar interbody fusion (n = 19). The groups were composed of 51%, 58%, and 40% men respectively, and the respective mean ages were 44, 43, and 42 years. The patients had experienced low back pain for at least 2 years (mean, approximately 8 years). They had been on sick leave for approximately 3 years. Pain was measured by a visual analog scale, and disability was assessed by the Oswestry Low Back Pain Questionnaire, the Million Visual Analogue Score, and the General Function Score. Depressive symptoms were measured by the Zung Depression Scale. The global overall rating of the result was assessed by the patient and an independent observer after 2 years. Hospitalization data including operation time, blood loss, blood transfusion, and days of hospitalization in connection with surgery were reported, along with complications and the fusion rate. Records from the Swedish Social Insurance Board providing information on sick leave and economic compensation for Swedish residents were used to evaluate the patients' work status. Results An independent observer examined 201 (91%) of 222 patients after 2 years, after 18 "group changers" and 3 dropouts had been excluded from the analyses. All surgical techniques were found to reduce pain and decrease disability substantially, but no significant differences were found among the groups. In all three groups, the patients rated the overall outcome similarly, as did the independent observer. The more demanding techniques in Groups 2 and 3 consumed significantly more resources in terms of operation time, blood transfusions, and days in hospital after surgery. The early complication rate was 6% in Group 1, 16% in Group 2, and 31% in Group 3. The fusion rate, as evaluated by plain radiograph, was 72% in Group 1, 87% in Group 2, and 91% in Group 3. Conclusions All the fusion techniques used in the study could reduce pain and improve function in this selected group of patients with severe chronic low back pain. There was no obvious disadvantage in using the least demanding surgical technique of posterolateral fusion without internal fixation.

Chronic low back pain and fusion: a comparison of three surgical techniques: a prospective multicenter randomized study from the Swedish lumbar spine study group.

Study design Systematic review and meta-regression. Objectives To compare the efficacy and safety of balloon kyphoplasty and vertebroplasty for the treatment of vertebral compression fractures, and to examine the prognostic factors that predict outcome. Summary of background data A previous systematic review of vertebroplasty by Levine et al in 2000 identified seven case series studies and no controlled studies. Methods A number of electronic databases were searched through March 1, 2004. Citation searches of included studies were undertaken and contact was made with experts in the field. No language restrictions were applied. All controlled and uncontrolled studies were included with the exception of case reports. Prognostic factors responsible for pain relief and cement leakage were examined using meta-regression. Results The following studies were included: balloon kyphoplasty (three nonrandomized comparative studies against conventional medical therapy and 13 case series), vertebroplasty (one nonrandomized comparative study against conventional medical care and 57 cases series), balloon kyphoplasty versus vertebroplasty (one nonrandomized comparative study). The majority of studies were undertaken in older women with osteoporotic vertebral compression fractures with long-term pain that was refractory to medical treatment. At this time, there is no good quality direct comparative evidence of balloon kyphoplasty versus vertebroplasty. From indirect comparison of case series evidence, the procedures appear to provide similar gains in pain relief while for balloon kyphoplasty there is better documentation of gains in patient functionality and quality of life. The level of cement leakage and number of reported adverse events (pulmonary emboli and neurologic injury) in balloon kyphoplasty was significantly lower than for vertebroplasty. These findings were confirmed by meta-regression analysis. Conclusions There is Level III evidence to support balloon kyphoplasty and vertebroplasty as effective therapies in the management of patients with symptomatic osteoporotic vertebral compression fractures refractory to conventional medical therapy. Although there was a good ratio of benefit to harm for both procedures, balloon kyphoplasty appears to offer the better adverse event profile. These conclusions need to be updated on the basis of the findings of ongoing randomized controlled trials.

Balloon kyphoplasty and vertebroplasty for vertebral compression fractures: a comparative systematic review of efficacy and safety.

This systematic review updates the understanding of the evidence base for balloon kyphoplasty (BKP) in the management of vertebral compression fractures. Detailed searches of a number of electronic databases were performed from March to April 2006. Citation searches of included studies were undertaken and no language restrictions were applied. All controlled and uncontrolled studies were included with the exception of case reports. Prognostic factors responsible for pain relief and cement leakage were examined using meta-regression. Combined with previous evidence, a total of eight comparative studies (three against conventional medical therapy and five against vertebroplasty) and 35 case series were identified. The majority of studies were undertaken in older women with osteoporotic vertebral compression fractures with long-term pain that was refractory to medical treatment. In direct comparison to conventional medical management, patients undergoing BKP experienced superior improvements in pain, functionality, vertebral height and kyphotic angle at least up to 3-years postprocedure. Reductions in pain with BKP appeared to be greatest in patients with newer fractures. Uncontrolled studies suggest gains in health-related quality of life at 6 and 12-months following BKP. Although associated with a finite level of cement leakage, serious adverse events appear to be rare. Osteoporotic vertebral compression fractures appear to be associated with a higher level of cement leakage following BKP than non-osteoporotic vertebral compression fractures. In conclusion, there are now prospective studies of low bias, with follow-up of 12 months or more, which demonstrate balloon kyphoplasty to be more effective than medical management of osteoporotic vertebral compression fractures and as least as effective as vertebroplasty. Results from ongoing RCTs will provide further information in the near future.

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Peter Fritzell

Papers

2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group.

The clinical importance of changes in outcome scores after treatment for chronic low back pain

Chronic low back pain and fusion: a comparison of three surgical techniques: a prospective multicenter randomized study from the Swedish lumbar spine study group.

Balloon kyphoplasty and vertebroplasty for vertebral compression fractures: a comparative systematic review of efficacy and safety.

Balloon kyphoplasty in the management of vertebral compression fractures: an updated systematic review and meta-analysis.