SWPW-FPS: Shock-Waves to Treat Fibromyalgia Pain

Sponsor

Dr Yves JACOT, MD (Other)

Overall Status

Unknown status

CT.gov ID

NCT03088215

Collaborator

Projet Suisse d'Assistance Medicale (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Myofascial Pain Syndrome MSK: Chronic Pain Syndromes (E.G. Fibromyalgia) Central Sensitization	Device: shock-waves	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treating Fibromyalgia Pain With Shock-Waves: a Randomized Study

Anticipated Study Start Date :

Oct 20, 2017

Anticipated Primary Completion Date :

Nov 20, 2018

Anticipated Study Completion Date :

Nov 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A / Shock-waves Will receive shock-waves	Device: shock-waves Application of shock-waves (radial and focused)
No Intervention: B / Nothing Will not receive shock-waves

Arm

Intervention/Treatment

Experimental: A / Shock-waves

Will receive shock-waves

Device: shock-waves

Application of shock-waves (radial and focused)

No Intervention: B / Nothing

Will not receive shock-waves

Outcome Measures

Primary Outcome Measures

Pain VAS [12 weeks]
Horizontal visual analog scale for pain (pain intensity)

Secondary Outcome Measures

Apparent change in successive Pain Body Maps over time [12 weeks]
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.
Interference scale of the Body Pain Index (BPI) [12 weeks]
Questionnaire reflecting interference of pain in quality of life
Patient Global Impression of Change scale (PGIC) [12 weeks]
Questionnaire reflecting effects of intervention (or non-intervention)from the participant's point of view

Other Outcome Measures

American College of Rheumatology (ACR) diagnostic criteria 2011 for Fibromyalgia [12 weeks]
Serves to assess if participants in intervention arm still meet the diagnostic criteria for Fibromyalgia at the end of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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