Fibromyalgia Clinical Trial
— SWPW-FPSOfficial title:
Treating Fibromyalgia Pain With Shock-Waves: a Randomized Study
Fibromyalgia pain syndrome is a common debilitating condition which associates mainly
generalised pain, emotional distress and cognitive symptoms. The etiology is unknown, and no
specific treatment exists so far.
Lately, shock-waves have been used successfully to treat painful skeletal muscle, tendons and
fascia, the investigators therefore hypothesize that shock-waves could be useful in
alleviating Fibromyalgia pain.
Two similar groups of participants bearing the condition will be prospectively compared.
The first group will benefit from the application of shock-waves weekly for 12 weeks, the
second will not.
The investigators intend to study if there is any difference in pain and quality of life
between the two groups at the end of the three months.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | November 20, 2018 |
Est. primary completion date | November 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - American College of Rheumatology 2011 diagnostic criteria for Fibromyalgia met - Aged between 18 and 65 years - Informed Consent Form signed Exclusion Criteria: - Known skeletal pathologies such as osteoarthritis of major joints and / or vertebrae, inflammatory states involving bones, joints, tendons or muscles, or previous heavy trauma directly causing the pain - Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, carcinoma, cardiovascular disease, pulmonary insufficiency, etc.), - Coagulopathies, anticoagulant or corticosteroid based medication, thrombosis. - Psychological distress, psychosis, dementia - Known or suspected non-compliance, drug or alcohol abuse, - Pregnancy - Enrolment of the investigator, his/her family members, employees and other dependent or vulnerable persons |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr Yves JACOT, MD | Projet Suisse d'Assistance Medicale |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | American College of Rheumatology (ACR) diagnostic criteria 2011 for Fibromyalgia | Serves to assess if participants in intervention arm still meet the diagnostic criteria for Fibromyalgia at the end of the study | 12 weeks | |
Primary | Pain VAS | Horizontal visual analog scale for pain (pain intensity) | 12 weeks | |
Secondary | Apparent change in successive Pain Body Maps over time | Participants will be distributed successive body map models where they are asked to draw the precise location and extension of the areas where they experience pain. The maps completed at every given time will then be compiled for each group (by computer). The final compiled pictures will be visually compared between each group. So far, it is not planned to do measurements (such as surface, etc...), the maps will serve mainly illustrate differences in pain extension between the two groups. |
12 weeks | |
Secondary | Interference scale of the Body Pain Index (BPI) | Questionnaire reflecting interference of pain in quality of life | 12 weeks | |
Secondary | Patient Global Impression of Change scale (PGIC) | Questionnaire reflecting effects of intervention (or non-intervention)from the participant's point of view | 12 weeks |
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