search
Back to results

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

Primary Purpose

Fibromyalgia, Myofascial Pain Syndrome, MSK: Chronic Pain Syndromes (E.G. Fibromyalgia)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
shock-waves
Sponsored by
Dr Yves JACOT, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Trigger Point Pain, Myofascial, shock-waves, extracorporeal shock-wave treatment (ESWT), pain, trigger point, referred pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    A / Shock-waves

    B / Nothing

    Arm Description

    Will receive shock-waves

    Will not receive shock-waves

    Outcomes

    Primary Outcome Measures

    Pain VAS
    Horizontal visual analog scale for pain (pain intensity)

    Secondary Outcome Measures

    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.
    Interference scale of the Body Pain Index (BPI)
    Questionnaire reflecting interference of pain in quality of life
    Patient Global Impression of Change scale (PGIC)
    Questionnaire reflecting effects of intervention (or non-intervention)from the participant's point of view

    Full Information

    First Posted
    March 10, 2017
    Last Updated
    October 6, 2017
    Sponsor
    Dr Yves JACOT, MD
    Collaborators
    Projet Suisse d'Assistance Medicale
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03088215
    Brief Title
    Shock-Waves to Treat Fibromyalgia Pain
    Acronym
    SWPW-FPS
    Official Title
    Treating Fibromyalgia Pain With Shock-Waves: a Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 20, 2017 (Anticipated)
    Primary Completion Date
    November 20, 2018 (Anticipated)
    Study Completion Date
    November 20, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr Yves JACOT, MD
    Collaborators
    Projet Suisse d'Assistance Medicale

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A / Shock-waves
    Arm Type
    Experimental
    Arm Description
    Will receive shock-waves
    Arm Title
    B / Nothing
    Arm Type
    No Intervention
    Arm Description
    Will not receive shock-waves
    Intervention Type
    Device
    Intervention Name(s)
    shock-waves
    Intervention Description
    Application of shock-waves (radial and focused)
    Primary Outcome Measure Information:
    Title
    Pain VAS
    Description
    Horizontal visual analog scale for pain (pain intensity)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Apparent change in successive Pain Body Maps over time
    Description
    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.
    Time Frame
    12 weeks
    Title
    Interference scale of the Body Pain Index (BPI)
    Description
    Questionnaire reflecting interference of pain in quality of life
    Time Frame
    12 weeks
    Title
    Patient Global Impression of Change scale (PGIC)
    Description
    Questionnaire reflecting effects of intervention (or non-intervention)from the participant's point of view
    Time Frame
    12 weeks
    Other Pre-specified Outcome Measures:
    Title
    American College of Rheumatology (ACR) diagnostic criteria 2011 for Fibromyalgia
    Description
    Serves to assess if participants in intervention arm still meet the diagnostic criteria for Fibromyalgia at the end of the study
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr Yves JACOT, MD
    Phone
    004179 703 24 72
    Email
    yves.jacot@cmvesenaz.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dr Yves JACOT, MD
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Shock-Waves to Treat Fibromyalgia Pain

    We'll reach out to this number within 24 hrs