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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to evaluate the analgesic effects of a 6 weeks osteopathic treatment on patients with fibromyalgia.
An osteopathic treatment could have a positive and durable effect on pain and quality of life on patients with fibromyalgia.
This technique, in addition to the standard treatment in a multidisciplinary care center, could be efficient by releasing muscle tension.
This is a 24 months multicenter (2 recruiting centers, 1 care center), randomized, and placebo-controlled study. The purpose is to evaluate the analgesic efficacy of a 6 weeks osteopathic treatment compared to a 6 week standard treatment on patients with fibromyalgia. It includes 6 osteopathic/standard sessions of 20 minutes (of one week apart), a follow-up at 3 months, 6 months and 12 months.
The primary aim of this study is to evaluate the pain after each osteopathic session, at the end of the 6 weeks treatment, and after each visit, judging by the patient's pain measured by a numeric scale (EVA).
The secondary aims of this study, based on clinical exams and questionnaires are to evaluate the quality of life, the patient activity and the sleep improvement after osteopathic treatment, and to investigate if osteopathic medicine improves fatigue, comorbidities, and decrease additional visits and medical investigations.
This study will also allow to identify the profile of the osteopathic treatment responders patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteopathy + | Experimental | 75 patients will make 6 osteopathic sessions |
|
| Osteopathy - | Active Comparator | 75 patients will make 6 factitious osteopathic sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic treatment | Procedure | osteopathic sessions of 20 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pain during the 6 weeks of osteopathic treatment | The assessment will be on the declarative of the patient. He will report every week the intensity of pain measured by a numeric scale (0 to 100). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Questionnaires: Fibromyalgia Impact Questionnaire (FIQ) and SF-36 (Short Form health survey) | 6 weeks after osteopathic treatment |
| Quality of life | Questionnaires: FIQ and SF-36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Serge PERROT, PU-PH | + 33 1.42.34.84.49 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel-Dieu Hospital | Paris | ÃŽle-de-France Region | 75004 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33948127 | Result | Coste J, Medkour T, Maigne JY, Perez M, Laroche F, Perrot S. Osteopathic medicine for fibromyalgia: a sham-controlled randomized clinical trial. Ther Adv Musculoskelet Dis. 2021 Apr 16;13:1759720X211009017. doi: 10.1177/1759720X211009017. eCollection 2021. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| Factitious osteopathic treatment |
| Procedure |
6 factitious osteopathic sessions of 20 minutes |
|
| 3 months after osteopathic treatment |
| Quality of life | Questionnaires: FIQ and SF-36 | 6 months after osteopathic treatment |
| Quality of life | Questionnaires: FIQ and SF-36 | 1 year after osteopathic treatment |
| Fatigue | Questionnaires: multidimensional fatigue inventory (MFI) scale | 6 weeks after osteopathic treatment |
| Fatigue | Questionnaires: MFI scale | 3 months after osteopathic treatment |
| Fatigue | Questionnaires: MFI scale | 6 months after osteopathic treatment |
| Fatigue | Questionnaires: MFI scale | 1 year after osteopathic treatment |
| Pain | Questionnaires: Brief Pain Inventory (BPI) | 6 weeks after osteopathic treatment |
| Pain | Questionnaires: BPI | 3 months after osteopathic treatment |
| Pain | Questionnaires: BPI | 6 months after osteopathic treatment |
| Pain | Questionnaires: BPI | 1 year after osteopathic treatment |
| D009422 |
| Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |