Shock-Waves to Treat Fibromyalgia Pain

NCT ID: NCT03088215

Last Updated: 2017-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-20
• Study Completion Date: 2018-11-20

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.

Conditions

Fibromyalgia; Myofascial Pain Syndrome; MSK: Chronic Pain Syndromes (E.G. Fibromyalgia); Central Sensitization

Keywords

Trigger Point Pain, Myofascial; shock-waves; extracorporeal shock-wave treatment (ESWT); pain; trigger point; referred pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A / Shock-waves

Will receive shock-waves

Group Type: EXPERIMENTAL

shock-waves

Intervention Type: DEVICE

Application of shock-waves (radial and focused)

B / Nothing

Will not receive shock-waves

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

shock-waves

Application of shock-waves (radial and focused)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Projet Suisse d'Assistance Medicale

OTHER

Sponsor Role: collaborator

Dr Yves JACOT, MD

OTHER

Sponsor Role: lead

Responsible Party

Dr Yves JACOT, MD

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dr Yves JACOT, MD

Role: STUDY_DIRECTOR

Central Contacts

Dr Yves JACOT, MD

Role: CONTACT

Phone: 004179 703 24 72

Email: yves.jacot@cmvesenaz.ch

Other Identifiers

SWPW-FPS - v1.0 - 07/03/2017

Identifier Type: -

Identifier Source: org_study_id