Table 2.

Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: A prospective randomized controlled study. Brox et al 2006. Pain.

Study Design	Randomized controlled trial.
Patients	60 patients, age 25–60.
Inclusion Criteria	Low back pain lasting longer than 1 year after previous surgery for disc herniation, score of at least 30 on the Oswestry Disability Index, degeneration at L4-L5 and/or L5-S1 (spondylosis) on X-ray.
Exclusion Criteria	Widespread myofascial pain or comorbid medical issues, spinal stenosis with neurologic signs, recurrent disc hernation or lateral recess stenosis with radiculopathy, previous spine fracture or fusion, generalized disc degeneration, medical abuse.
Treatments Compared	Lumbar fusion with posterior transpedicular screws vs. cognitive intervention (lecture) and exercises (3 daily physical exercise sessions for 3 weeks).
Loss to Follow-Up	3% loss to follow up at 1 year.
Outcome Measures	Primary: Oswestry Disability Index (ODI) Secondary: Questionnaires, pain index, use of and type of pain medication, General Function Score, Hopkins Symptom Check List-25 (emotional distress measure), Fear-Avoidance Belief Questionnaire, Global Back Disability Question (function), work status, treatment beliefs and expectancies, Prolo Scale (functional status part), radiographic assessment of fusion.
Findings	No significant difference in the primary outcome of ODI. At 1 year, in the fusion group, ODI decreased from 47 to 38 and after cognitive intervention and exercises, ODI decreased from 45 to 32 (p = 0.43). The mean difference between treatments was −9.7 (−21.7, 1.7; p = 0.09) in favor of cognitive intervention, after adjusting for gender and treatment preference. The surgery group did not improve significantly in the secondary outcome measures other than back pain. Fear-avoidance for physical activity and fingertip-floor distance improved in the conservatively managed group.
Strengths	Randomized controlled trial, assessed many secondary outcome measures.
Weaknesses	Lack of true control group, small size, large variations between patients.
Bottom Line	Provides evidence suggesting that lumbar fusion did not show significant benefit over cognitive intervention and exercises in patients with chronic low back pain after previous disc herniation surgery.