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
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
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
NCT ID
NCT03088215
First Posted
March 10, 2017
Last Updated
October 6, 2017
Sponsor
Dr Yves JACOT, MD
Collaborators
Projet Suisse d'Assistance Medicale
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