NCT05706103 Exercise Therapy for Recurrent Low Back Pain: Unraveling the Puzzle of Peripheral Muscle and Central Brain Changes (B670201420984)
| NCT ID | NCT05706103 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Low Back Pain, Recurrent |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2021-01-04 |
| Primary Completion | 2025-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Exercise therapy has been shown to be effective in decreasing pain and improving function for patients with recurrent low back pain (LBP). Research on the mechanisms that trigger and/or underlie the effects of exercise therapy on LBP problems is of critical importance for the prevention of recurring or persistence of this costly and common condition. One factor that seems to be crucial within this context is the dysfunction of the back muscles. Recent pioneering results have shown that individuals with recurring episodes of LBP have specific dysfunctions of these muscles (peripheral changes) and also dysfunctions at the cortical level (central changes). This work provides the foundation to take a fresh look at the interplay between peripheral and central aspects, and its potential involvement in exercise therapy. The current project will draw on this opportunity to address the following research questions: What are the immediate (after a single session) and the long-term effects (after 18 repeated sessions) of exercise training on: (1) back muscle structure; (2) back muscle function; (3) the structure of the brain; (4) and functional connectivity of the brain. This research project also aims to examine whether the effects are dependent on how the training was performed. Therefore a specific versus a general exercise program will be compared.
Eligibility Criteria
Inclusion Criteria: * History of non-specific recurrent LBP with the first onset being at least 6 months ago * At least 2 episodes of LBP/year, with an 'episode' implying pain lasting a minimum of 24 hours which is preceded and followed by at least 1 month without LBP * Minimum LBP intensity during episodes should be ≥2/10 on a numeric rating scale (NRS) from 0 to 10 * During remission the NRS intensity for LBP should be 0. * LBP should be of that severity that it limits activities of daily living * LBP should be of that severity that a (para)medic has been consulted at least once regarding the complaints * Flexion pattern of LBP Exclusion Criteria: * Chronic LBP (i.e. duration remission \<1 month) * Subacute LBP (i.e. first onset between 3 and 6 months ago) * Acute (i.e. first onset \<3 months ago) LBP * Specific LBP (i.e. LBP proportionate to an identifiable pathology, e.g. lumbar radiculopathy) * Patients with neuropathic pain * Patients with chronic widespread pain as defined by th