Shock-Waves to Treat Fibromyalgia Pain

Fibromyalgia Clinical Trial

— SWPW-FPS  

Official title:

Treating Fibromyalgia Pain With Shock-Waves: a Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03088215
• Other study ID #: SWPW-FPS - v1.0 - 07/03/2017
• Status: Not yet recruiting
• Phase: N/A
• First received: March 10, 2017
• Last updated: October 6, 2017
• Start date: October 20, 2017
• Est. completion date: November 20, 2018

Study information

• Verified date: October 2017
• Source: Projet Suisse d'Assistance Medicale
• Contact: Dr Yves JACOT, MD
• Phone: 004179 703 24 72
• Email: yves.jacot[@]cmvesenaz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Central Sensitization
• Chronic Pain
• Fibromyalgia
• MSK: Chronic Pain Syndromes (E.G. Fibromyalgia)
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

Device:
• shock-waves
Application of shock-waves (radial and focused)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr Yves JACOT, MD	Projet Suisse d'Assistance Medicale

Outcome

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