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Behavioral graded activity following first-time lumbar disc surgery: 1-year results of a randomized clinical trial [with consumer summary]
Ostelo RW, de Vet HC, Vlaeyen JW, Kerckhoffs MR, Berfelo WM, Wolters PM, van den Brandt PA
Spine 2003 Aug 15;28(16):1757-1765
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

STUDY DESIGN AND OBJECTIVES In a randomized clinical trial, the effectiveness of behavioral graded activity was assessed as compared to usual care provided by physiotherapists for patients after first-time lumbar disc surgery (n = 105). SUMMARY OF BACKGROUND DATA Little is known about the effectiveness of rehabilitation programs following lumbar disc surgery. Most programs focus on biomechanical aspects, whereas psychosocial factors are hardly addressed. The aim of the behavioral graded activity program, which is an operant treatment, is to alter psycho-social factors such as fear of movement and pain catastrophizing, which might subsequently lead to improved functional status and higher rates of recovery. Behavioral treatments for patients following lumbar disc surgery have not yet been assessed in a randomized clinical trial. METHODS Inclusion criteria: age between 18 and 65 years; first-time lumbar disc surgery; restrictions in normal activities of daily living. Exclusion criteria: surgical complications and confirmed and relevant underlying diseases. Outcome assessment took place at 6 and 12 months after randomization. RESULTS Six months after randomization, 62% of the patients had recovered following usual care versus 65% of the patients following behavioral graded activity. After 12 months, 73% and 75%, respectively, had recovered. Differences between intervention groups, 3% and 2% respectively, after 6 and 12 months are not statistically significant. Furthermore, there were no differences between the two groups regarding functional status, pain, pain catastrophizing, fear of movement, range of motion, general health, social functioning or return to work. After 1 year, 4 of the behavioral graded activity cases had undergone another operation versus 2 of usual care cases. CONCLUSION Both fear of movement and pain catastrophizing seem to be unaffected by either treatment in these patients. It is concluded that treatment principles derived from theories within the field of chronic low back pain might not apply to these patients. After 1 year of follow-up, there were no statistically significant or clinically relevant differences between the behavioral graded activity program and usual care as provided by physiotherapists for patients following first-time lumbar disc surgery.
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