Shock-Waves to Treat Fibromyalgia Pain

NCT03088215 | Unknown

• 1 other identifier: SWPW-FPS - v1.0 - 07/03/2017
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Pain VAS

  Horizontal visual analog scale for pain (pain intensity)

  12 weeks

Secondary Outcomes (3)

• Apparent change in successive Pain Body Maps over time

  12 weeks

• Interference scale of the Body Pain Index (BPI)

  12 weeks

• Patient Global Impression of Change scale (PGIC)

  12 weeks

Other Outcomes (1)

• American College of Rheumatology (ACR) diagnostic criteria 2011 for Fibromyalgia

  12 weeks

Study Arms (2)

A / Shock-waves

EXPERIMENTAL

Will receive shock-waves

Device: shock-waves

B / Nothing

NO INTERVENTION

Will not receive shock-waves

Interventions

shock-waves DEVICE

Application of shock-waves (radial and focused)

A / Shock-waves

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American College of Rheumatology 2011 diagnostic criteria for Fibromyalgia met
• Aged between 18 and 65 years
• Informed Consent Form signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Yves JACOT, MD: lead
• Projet Suisse d'Assistance Medicale: collaborator

MeSH Terms

Conditions

Fibromyalgia; Myofascial Pain Syndromes; Pain; Pain, Referred

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Yves JACOT, MD

  STUDY DIRECTOR

Central Study Contacts

Dr Yves JACOT, MD

CONTACT

004179 703 24 72; yves.jacot@cmvesenaz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 23, 2017
• Study Start: October 20, 2017
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: October 9, 2017

Record last verified: 2017-10