Table 1.

Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Brox, et al. 2003. Spine.

Study Design	Single blind randomized study.
Patients	64 total patients age 25–60.
Inclusion Criteria	Low back pain for greater than 1 year and evidence of disc degeneration at L4-L5 and/or L5-S1 on radiographic examination. Also: age 25–60, score of at least 30 on the Oswestry Disability Index.
Exclusion Criteria	Widespread myofascial pain, spinal stenosis with neurologic signs, recurrent disc herniation or lateral recess stenosis with radiculopathy, inflammatory disease, previous spinal fracture or spine surgery, pelvic pain, generalized disc degeneration on imaging, medical illness that excluded either interventions, medical abuse, reluctance to accept either treatments.
Treatments Compared	Lumbar fusion with posterior transpedicular screws and post-operative physical therapy vs. cognitive intervention (including a lecture to promote comprehension that ordinary activities are not detrimental to the spine) and 3 daily exercise sessions for 3 weeks.
Loss to Follow-Up	There was 3% loss to follow up.
Outcome Measures	Primary: Oswestry Disability Index (ODI) Secondary: Questionnaire: pain index, use of pain medications, General Function Score, Hopkins Symptom Check List-25 (emotional distress), Waddel’s Fear-Avoidance Belief Questionnaire (FABQ), life satisfaction score, Global Back Disability rating (overall function), work status, Prolo Scale (overall functional and economic status). Fingertip-floor distance measurement, isokinetic trunk muscle (extension) test, back muscle size and density (measured by a radiologist).
Findings	At 1 year, the ODI decreased from 41 to 26 after surgery and 42 to 30 after cognitive & exercise intervention. Mean difference between the groups was 2.3 (−6.7 to 11.4, p = 0.33), which was neither clinically relevant nor significant. Fear-avoidance beliefs and fingertip-floor distance had better outcomes after conservative treatment, while leg pain decreased more with surgery. Other outcome measures were not different. The ODI difference between patients who adhered to their assigned treatment was 1.3. There was no difference between groups in return to work status. Patients’ overall ratings were not significantly different.
Strengths	Randomized, single blinded study that assessed many secondary outcome measures which took into account global function, work status, psychological well-being, spine motion, strength, and medication usage.
Weaknesses	Small size of the study, large variations between patients (wide confidence intervals), lack of “no treatment” group to assess natural history of the disease.
Bottom Line	Provides good evidence that at 1 year there was equal improvement in patients who were randomized to instrumented lumbar fusion or to cognitive intervention and exercise. Furthermore, the cognitive intervention and exercise also reduced fear-avoidance beliefs.