Shock-Waves to Treat Fibromyalgia Pain (SWPW-FPS)

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.

Study Overview

• Status: Unknown
• Conditions: Fibromyalgia; Central Sensitization; Myofascial Pain Syndrome; MSK: Chronic Pain Syndromes (E.G. Fibromyalgia)
• Intervention / Treatment: Device: shock-waves

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Yves JACOT, MD; Phone Number: 004179 703 24 72; Email: yves.jacot@cmvesenaz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr Yves JACOT, MD
• Collaborators: Projet Suisse d'Assistance Medicale
• Investigators: Study Director: Dr Yves JACOT, MD

Study record dates

Study Major Dates

• Study Start (Anticipated): October 20, 2017
• Primary Completion (Anticipated): November 20, 2018
• Study Completion (Anticipated): November 20, 2018

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: pain; trigger point; Trigger Point Pain, Myofascial; shock-waves; extracorporeal shock-wave treatment (ESWT); referred pain
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Chronic Pain; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes
• Other Study ID Numbers: SWPW-FPS - v1.0 - 07/03/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No