Treatment and Assessment of Fibromyalgia
Physical Approaches to the Management of Fibromyalgia - A Multidisciplinary Approach
1 other identifier
interventional
12
1 country
1
Brief Summary
Fibromyalgia is a common disorder affecting approximately 2% of the Canadian population. Patients diagnosed with fibromyalgia commonly present with chronic, widespread pain as well as fatigue, depression, mood disturbances, and cognitive symptoms. As a result, fibromyalgia has a negative impact on the patient's quality of life, and a negative financial impact for them, society, and the healthcare system, through lost wages and delayed diagnosis. Therefore a more direct and conclusive method of diagnosis is needed. Recently, fibromyalgia diagnosis has been based on the modified American College of Rheumatology Preliminary Diagnostic Criteria for fibromyalgia. To assist with diagnosis, recent evidence shows that compared to healthy people, people with fibromyalgia present with differences on functional MRI (fMRI) whole brain scans, as well as differences in a functional blood biomarker challenge test, known as fm/a. The fm/a determines the function of the immune system in response to a stimulus, and has been used previously to show that people with fibromyalgia have a severely blunted immune response. Despite the number of treatment options available, interventions for chronic pain remain largely ineffective. In light of its demonstrated effectiveness, safety, and ease of use in previous studies, radial shockwave therapy (RSWT) has been selected for inclusion in the present study. The main objective of this study is to determine the efficacy and effect of RSWT compared to placebo on the symptoms frequently reported in association with fibromyalgia. In addition, the fm/a and brain activity associated with pain patterns (fMRI) may assist in early diagnosis and prediction of treatment success in patients with fibromyalgia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedAugust 20, 2019
August 1, 2019
1.9 years
April 20, 2016
August 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Visual Analog Scale (VAS) Pain Score from Baseline to 6 Weeks
Subject pain will be rated using a VAS by the participant for the 3 most painful regions.
Measured pre-treatment (baseline) and post-treatment (at 6 weeks)
Secondary Outcomes (4)
Focus Group Qualitative Themes Identified from Transcripted Survey Responses
Post-treatment (at 6 weeks)
Change in Pressure Pain Threshold from Baseline to 6 Weeks
Measured pre-treatment (baseline) and post-treatment (at 6 weeks)
Change in Blood Biomarker fMA Test from Baseline to 6 Weeks
Measured pre-treatment (baseline) and post-treatment (at 6 weeks)
Change in Functional Magnetic Resonance Imaging from Baseline to 6 Weeks
Measured pre-treatment (baseline) and post-treatment (at 6 weeks)
Study Arms (2)
Group 1 - Radial Shockwave Therapy Group
EXPERIMENTALParticipants in Group 1 will receive RSWT to the most painful spot within each of the 3 most painful regions as described by the participant. Treatments will be spaced one week apart over a 5 week period of time. 5 weekly sessions with treatment to the painful areas will be undertaken with 500 shocks (1.5 bar, 15 Hz), then 1000 shocks (2 bar, 8 Hz), and finally 500 shocks (1.5 bar, 15 Hz) to the most painful spot.
Group 2 - Placebo Group
PLACEBO COMPARATORParticipants in Group 2 will receive a placebo treatment with a soft rubber cap applied to the applicator, leaving air between the transmitter and the cap and the participant's skin so that no shockwave will be generated nor applied to the participant's skin. Treatments will be spaced one week apart over a 5 week period of time. 5 weekly sessions with placebo treatment to the painful areas will be undertaken with 2000 placebo shocks (15 Hz) producing an audible sound but no therapeutic dosage to the most painful spot. Upon completion of the placebo treatment, participant's will be offered the experimental treatment but this data will not be used for comparison and analysis.
Interventions
5 treatments in total scheduled weekly; RSWT to the painful areas will be undertaken with 500 shocks (1.5 bar, 15 Hz), then 1000 shocks (2 bar, 8 Hz), and finally 500 shocks (1.5 bar, 15 Hz) to the most painful spot within each of the 3 most painful regions as described by the participant.
5 treatments in total scheduled weekly; placebo to the painful areas will be undertaken with 2000 shocks to the most painful spot within each of the 3 most painful regions as described by the participant.
Eligibility Criteria
You may qualify if:
- Men and women aged 18-60 years
- diagnosed with FM by a physician based on ARC Diagnostic Criteria\\
- willing to provide informed consent to be randomized to either of the treatment pathways and willing to follow the study protocol
- have no contraindications to MRI (determined by MRI safety screening with a licensed MRI technologist).
You may not qualify if:
- Have any vascular, neurological, or other condition or disorder (e.g., rheumatoid arthritis, osteoarthritis) that could reasonably explain pain
- have implanted metal non compatible with MRI or shockwave therapy
- are pregnant
- are diagnosed with thrombosis, thrombophlebitis, or coagulation disorders
- have anxiety or claustrophobia that will be aggravated by the confined spaces of the fMRI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lakehead University
Thunder Bay, Ontario, P7B 5E1, Canada
Related Publications (1)
Sanzo P, Agostino M, Fidler W, Lawrence-Dewar J, Pearson E, Zerpa C, Niccoli S, Lees SJ. Shockwave therapy and fibromyalgia and its effect on pain, blood markers, imaging, and participant experience - a multidisciplinary randomized controlled trial. Physiother Theory Pract. 2025 Jan;41(1):99-114. doi: 10.1080/09593985.2024.2321503. Epub 2024 Feb 21.
PMID: 38384123DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Sanzo, DScPT
Lakehead University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2016
First Posted
May 3, 2016
Study Start
February 1, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
August 20, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- Study participants may obtain a summary report of the study results upon completion of analysis and publication of findings.
- Access Criteria
- Study participants may contact research team for information.
Potential participants will have the opportunity to indicate that they would like individual results of study and provide contact information so that contact can be made upon completion of the study and information can be provided at that time.