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Clinical trial

Development of Clinical Prediction Rules for Rehabilitation in Chronic Nonspecific Low Back Pain Patients

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Last updated:10th Feb 2014

This project concerns the rehabilitation of nonspecific chronic low back pain patients (CLBP), in particular conservative rehabilitation by means of exercise therapy. Exercise therapy covers a broad spectrum of different kind of therapy approaches in daily practice. For example stabilization therapy, isometric muscle training, general exercises to improve general fitness... In the European guidelines and the Belgian report on chronic low back pain of the "Federaal Kenniscentrum voor de gezondheidszorg (KCE)" supervised exercise therapy and multidisciplinary rehabilitation (bio-psycho-social) are recommended, due to the high level of evidence. The content or type of exercises are not specified. An important recommendation of the European guideline is the need for development of tools to improve the classification and identification of specific clinical sub-groups of low back pain patients to determine the effectiveness of specific exercise interventions.

Consequently, we will investigate three active rehabilitation approaches for back pain: stabilization therapy, general active exercise therapy and isometric training devices, well known in Flanders and described in international peer reviewed journals. For each type of exercise therapy a clinical prediction rule (CPR) will be determined. Recent systematic reviews show the lack of CPR for exercise therapy in low back pain patients. The methodology to develop a validated and applicable CPR contains 3 different phases: 1. derivation phase, 2. validation phase, 3. impact phase.

Phase 2: validation phase. The CPR will be applied in a new but comparable test group to confirm findings of phase. The RCT design with 3 treatment groups (stabilization therapy/ general active exercise therapy/ isometric training devices) that was accomplished in phase 1 will be repeated. The prediction rule will be applied after at random assignment of the patients to an intervention group. Within each intervention group treatment success will be compared between "matched treatment subgroup" and "unmatched treatment subgroup" according to the phase 1 prediction rules for each of the three intervention types.

Phase 3: Impact analysis. Patient satisfaction will be analyzed (SF36, patient satisfaction questionnaire, return to work). Work field will be informed on completed CPR and changes in therapists behavior will be evaluated.

Our scientific goal is to: Develop a validated CPR that is applicable in nonspecific CLBP resulting in a better choice of active rehabilitation therapy, tailor fit for each individual patient.

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Study start date 2014-02-10

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