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| Name | Class |
|---|---|
| Velux Fonden | OTHER |
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The purpose of this study is to compare patients with low back pain (LBP) and Modic Changes from The Backcenter Funen, Ringe:
To compare the effect of two types of non-operative treatments:
A. exercise and advice to be physically active
B. restitution and advice not to overload the spine
To investigate if the results of the treatment are influenced by gender, age, smoking, and physical load.
The clinical experience is that many patients with Modic changes have relatively severe and persistent LBP, which typically appears to be resistant to treatment. Furthermore, a retrospective study at The Backcenter Funen, Ringe, shows that patients with MC fail to improve engaging physical activity. This is unfortunate, because the typical rehabilitation for patients with persistent LBP is back exercises and information about keeping physically active. This means that this relatively large subgroup of patients with Modic changes probably does not improve with the rehabilitation tools used today.
A randomised controlled trial has therefore been designed to study the specific subgroup of patients with Modic changes. In this study we will compare the present "state-of-the art" rehabilitation approach to persistent LBP (namely to exercise and keep active) with a new concept (restitution). The justification for this is that restitution reduces mechanical stress on the vertebrae and therefore would allow heeling of the possible micro fractures in Modic changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and advise to stay active | Active Comparator | The exercise group received exercises for the stabilising muscles in the low back and abdomen together with dynamic exercises, exercises for postural instability and light physical fitness training. |
|
| Rest and use of flexible lumbar belt | Experimental | The rest group was instructed to avoid hard physical activity and to rest twice daily for one hour, by lying down |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Back exercise: At home every day. In groups once a week. Duration 10 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is actual LBP, as measured with an "11 point box scale". | 10 weeks and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| General Health, as measured with the EQ-5D (EuroQol) | 10 weeks and 12 months | |
| General improvement, as measured with two global instruments a 7-point transition question and an assessment score consisting of a "bothersomeness index" | 10 weeks and 12 months |
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Inclusion Criteria:
Primary inclusion criteria for receiving MRI
Secondary inclusion criteria for receiving MRI
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus Manniche, Prof.Dr.Med. | Spine Centre of Southern Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Centre of Southern Denmark | Middelfart | 5500 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22376791 | Derived | Jensen RK, Leboeuf-Yde C, Wedderkopp N, Sorensen JS, Manniche C. Rest versus exercise as treatment for patients with low back pain and Modic changes. A randomized controlled clinical trial. BMC Med. 2012 Feb 29;10:22. doi: 10.1186/1741-7015-10-22. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Restitution | Other | Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks. |
|
| Physical functions measured with "Roland Morris Disability Questionnaire" | 10 weeks and 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |