Fibromyalgia Clinical Trial
Official title:
Physical Approaches to the Management of Fibromyalgia - A Multidisciplinary Approach
Verified date | August 2019 |
Source | Lakehead University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Men and women aged 18-60 years 2. diagnosed with FM by a physician based on ARC Diagnostic Criteria\ 3. willing to provide informed consent to be randomized to either of the treatment pathways and willing to follow the study protocol 4. have no contraindications to MRI (determined by MRI safety screening with a licensed MRI technologist). Exclusion Criteria: 1. Have any vascular, neurological, or other condition or disorder (e.g., rheumatoid arthritis, osteoarthritis) that could reasonably explain pain 2. have implanted metal non compatible with MRI or shockwave therapy 3. are pregnant 4. are diagnosed with thrombosis, thrombophlebitis, or coagulation disorders 5. have anxiety or claustrophobia that will be aggravated by the confined spaces of the fMRI. |
Country | Name | City | State |
---|---|---|---|
Canada | Lakehead University | Thunder Bay | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lakehead University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Focus Group Qualitative Themes Identified from Transcripted Survey Responses | Participants will be invited to participate in a focus group lead by a member of the research team during which qualitative feedback regarding the study will be discussed. This is a patient-centred approach that will help the investigators engage the fibromyalgia community and allow this input to guide future study design. | Post-treatment (at 6 weeks) | |
Secondary | Change in Pressure Pain Threshold from Baseline to 6 Weeks | Pressure pain threshold will be measured on the most painful spot within each of the 3 most painful regions using a Baseline© Pressure Tolerance Meter (60 lbs). Pressure will be applied perpendicular to the tissue in the 3 most painful regions as indicated by the participant. The participant will be asked to report when the pressure applied to the region became painful and the amount of pressure shall be recorded in pounds on the data abstraction form. A 30 second rest shall be allowed for recovery and the same technique shall be applied to the other painful locations. The specific location of the painful region shall be marked and documented by a trained member of the research team. | Measured pre-treatment (baseline) and post-treatment (at 6 weeks) | |
Secondary | Change in Blood Biomarker fMA Test from Baseline to 6 Weeks | A blood sample will be drawn by a registered phlebotomist. Specialized vacutainers will be used to isolate Peripheral Blood Mononuclear Cells (PBMCs) which will be later used in cytokine protein analysis. | Measured pre-treatment (baseline) and post-treatment (at 6 weeks) | |
Secondary | Change in Functional Magnetic Resonance Imaging from Baseline to 6 Weeks | Resting State fMRI - An 8 minute task free scan will be acquired to investigate alterations in the functional connectivity of the default mode network, found previously to be altered in chronic pain conditions including FM. Recruitment of the pain matrix - An 8 minute scan with an alternating 30 second on and 30 second off evoked pressure pain stimulus applied to the affected area. T1 high resolution anatomical imaging - This scan lasting about 8 minutes is used for the registration of functional images to allow group fMRI analysis as well as for overlay purposes. It will also be used to evaluate grey matter volume through a VBM analysis. Diffusion Tensor Image - This 9 minute scan allows visualization of the white matter tracts and will be used for evaluation of white matter integrity. | Measured pre-treatment (baseline) and post-treatment (at 6 weeks) |
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