Effectiveness of behavioral graded activity after first-time lumbar disc surgery: short term results of a randomized controlled trial.

Behavioral approaches to treating patients following lumbar disc surgery are becoming increasingly popular. The treatment method is based on the assumption that pain and pain disability are not only influenced by somatic pathology, if found, but also by psychological and social factors. A recent study highlighted the effectiveness of cognitive-behavioral interventions, as compared to no treatment, for chronic low back patients. However, to the authors' knowledge, there is no randomized controlled trial that evaluates a behavioral program for patients following lumbar disc surgery. The purpose of this study was to assess the effectiveness of a behavioral graded activity (BGA) program compared to usual care (UC) in physiotherapy following first-time lumbar disc surgery. The BGA program was a patient-tailored intervention based upon operant therapy. The essence of the BGA is to teach patients that it is safe to increase activity levels. The study was designed as a randomized controlled trial. Assessments were carried out before and after treatment by an observer blinded to treatment allocation. Patients suffering residual symptoms restricting their activities of daily living and/or work at the 6 weeks post-surgery consultation by the neurosurgeon were included. The exclusion criteria were: complications during surgery, any relevant underlying pathology, and any contraindication to physiotherapy or the BGA program. Primary outcome measures were the patient's Global Perceived Effect and the functional status. Secondary measures were: fear of movement, viewing pain as extremely threatening, pain, severity of the main complaint, range of motion, and relapses. Physiotherapists in the BGA group received proper training. Between November 1997 and December 1999, 105 patients were randomized; 53 into the UC group and 52 into the BGA group. The unadjusted analysis shows a 19.3% (95% CI: 0.1 to 38.5) statistically significant difference to the advantage of the UC group on Global Perceived Effect. This result, however, is not robust, as the adjusted analyses reveal a difference of 15.7% (95% CI: -3.9 to 35.2), which is not statistically significant. For all other outcome measures there were no statistically significant or clinically relevant differences between the two intervention groups. In general, the physiotherapists' compliance with the BGA program was satisfactory, although not all treatments, either in the BGA or the UC group, were delivered exactly as planned, resulting in less contrast between the two interventions than had been planned for. There was one re-operation in each group. The BGA program was not more effective than UC in patients following first-time lumbar disc surgery. For Global Perceived Effect there was a borderline statistically significant difference to the advantage of the UC group. On functional status and all other outcome measures there were no relevant differences between interventions. The number of re-operations was negligible, indicating that it is safe to exercise after first-time disc surgery.

Rehabilitation after lumbar disc surgery.

BACKGROUND: Although several rehabilitation programs, physical fitness programs or protocols regarding instruction for patients to return to work after lumbar disc surgery have been suggested, little is known about the efficacy and effectiveness of these treatments. There are still persistent fears of causing re-injury, re-herniation, or instability. OBJECTIVES: The objective of this systematic review was to evaluate the effectiveness of active treatments that are used in the rehabilitation after first-time lumbar disc surgery. SEARCH STRATEGY: We searched the MEDLINE, EMBASE and Psyclit databases up to April 2000 and the Cochrane Controlled Trials Register 2001, Issue 3. SELECTION CRITERIA: Both randomized and non-randomized controlled trials on any type of active rehabilitation program after first-time disc surgery were included. DATA COLLECTION AND ANALYSIS: Two independent reviewers performed the inclusion of studies and two other reviewers independently performed the methodological quality assessment. A rating system that consists of four levels of scientific evidence summarizes the results. MAIN RESULTS: Thirteen studies were included, six of which were of high quality. There is no strong evidence for the effectiveness for any treatment starting immediately post-surgery, mainly because of lack of (good quality) studies. For treatments that start four to six weeks post-surgery there is strong evidence (level 1) that intensive exercise programs are more effective on functional status and faster return to work (short-term follow-up) as compared to mild exercise programs and there is strong evidence (level 1) that on long term follow up there is no difference between intensive exercise programs and mild exercise programs with regard to overall improvement. For all other primary outcome measures for the comparison between intensive and mild exercise programs there is conflicting evidence (level 3) with regard to long-term follow-up. Furthermore, there is no strong evidence for the effectiveness of supervised training as compared to home exercises. There was also no strong evidence for the effectiveness of multidisciplinary rehabilitation as compared to usual care. There is limited evidence (level 3) that treatments in working populations that aim at return to work are more effective than usual care with regard to return to work. Also, there is limited evidence (level 3) that low-tech and high-tech exercises, started more than 12 months post-surgery are more effective in improving low back functional status as compared to physical agents, joint manipulations or no treatment. Finally, there is no strong evidence for the effectiveness of any specific intervention when added to an exercise program, regardless of whether exercise programs start immediately post-surgery or later. None of the investigated treatments seem harmful with regard to re-herniation or re-operation. REVIEWER'S CONCLUSIONS: There is no evidence that patients need to have their activities restricted after first time lumbar disc surgery. There is strong evidence for intensive exercise programs (at least if started about 4-6 weeks post-operative) on short term for functional status and faster return to work and there is no evidence they increase the re-operation rate. It is unclear what the exact content of post-surgery rehabilitation should be. Moreover, there are no studies that investigated whether active rehabilitation programs should start immediately post-surgery or possibly four to six weeks later.

Behavioral-graded activity compared with usual care after first-time disk surgery: considerations of the design of a randomized clinical trial.

OBJECTIVE: To present the design of a trial on the effectiveness of a behavioral-graded activity model. DESIGN: Randomized clinical trial. PATIENTS: Patients undergoing first-time lumbar disk surgery who still have low-back pain at the 6-week neurosurgical consultation. INTERVENTIONS: A patient-tailored behavioral-graded activity program that is based on operant therapy. The key elements of this program are baseline measurements, goal-setting, and time-contingency. This program is compared with usual care in physiotherapy, which is pain-contingent. OUTCOME MEASURES: Primary measures are the patient's global impression of the effect and their functional status. Secondary measures are kinesiophobia, catastrophizing, pain, main complaint, range of motion, and relapses. The direct and indirect costs will also be assessed. The effect measures are rated before randomization and 3, 6, and 12 months later. DISCUSSION: Several trials have been conducted on the effectiveness of behavioral treatments. Subjects were always patients with chronic low-back pain. In this trial, we apply such a treatment in patients after first-time disk surgery in a primary care setting.