Shock-Waves to Treat Fibromyalgia Pain

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Fibromyalgia Pain Syndrome (FPS) 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. It bears some similarities with another, more localised clinical condition : the Myofascial Pain Syndrome (MPS), which results in pain caused by, amongst others, muscular trigger points. Lately, FPS and MPS have both been classified as belonging to a new, larger entity : Central Sensitivity Syndromes (CSS), in which a strong and chronic peripheral sensitive stimulus (like musculoskeletal pain) is believed to induce, after some time, an enhanced response of the central nervous system (CNS) towards that same stimulus, with the result that the stimulus will be felt more powerfully (central sensitization, CS). This is secondary to neuroplastic changes in the CNS, which are reversible to some extent. Since shock-waves are effective to treat pain in MPS (by eliminating trigger points and thus restoring muscle and tissue function), and since MPS and FPS could be linked by a common pathophysiologic mechanism (CSS), the investigators hypothesize that shock waves could be beneficial in treating pain in FPS. Two groups of 20 participants will be prospectively compared over a three month's period. One group will receive shock-waves on painful muscular areas weekly for 12 weeks, the other group will not receive any shock-waves. The investigators intend to study if there is any difference in pain and quality of life after the end of the three months.

Official Title
-----------------
Treating Fibromyalgia Pain With Shock-Waves: a Randomized Study

Conditions
-----------------
Myofascial Pain Syndrome, Central Sensitization, Fibromyalgia, MSK: Chronic Pain Syndromes (E.G. Fibromyalgia)

Intervention / Treatment
-----------------
* Device: shock-waves


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A / Shock-waves<br>Will receive shock-waves | Device: shock-waves<br>* Application of shock-waves (radial and focused)<br>|
| No Intervention: B / Nothing<br>Will not receive shock-waves | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain VAS | Horizontal visual analog scale for pain (pain intensity) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Interference scale of the Body Pain Index (BPI) | Questionnaire reflecting interference of pain in quality of life | 12 weeks | 
| Patient Global Impression of Change scale (PGIC) | Questionnaire reflecting effects of intervention (or non-intervention)from the participant's point of view | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trigger Point Pain, Myofascial, shock-waves, extracorporeal shock-wave treatment (ESWT), pain, trigger point, referred pain