Treatment and Assessment of Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT02760212|
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : August 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Device: Radial Shockwave Therapy Other: Placebo Comparator: Group 2 - Placebo Group||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Physical Approaches to the Management of Fibromyalgia - A Multidisciplinary Approach|
|Actual Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: Group 1 - Radial Shockwave Therapy Group
Participants 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.
Device: Radial Shockwave Therapy
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.
Other Name: Storz D-Actor 100
Placebo Comparator: Group 2 - Placebo Group
Participants 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.
Other: Placebo Comparator: Group 2 - Placebo Group
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.
Other Name: Storz D-Actor 100
- Change in Visual Analog Scale (VAS) Pain Score from Baseline to 6 Weeks [ Time Frame: Measured pre-treatment (baseline) and post-treatment (at 6 weeks) ]Subject pain will be rated using a VAS by the participant for the 3 most painful regions.
- Focus Group Qualitative Themes Identified from Transcripted Survey Responses [ Time Frame: Post-treatment (at 6 weeks) ]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.
- Change in Pressure Pain Threshold from Baseline to 6 Weeks [ Time Frame: Measured pre-treatment (baseline) and post-treatment (at 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.
- Change in Blood Biomarker fMA Test from Baseline to 6 Weeks [ Time Frame: Measured pre-treatment (baseline) and post-treatment (at 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.
- Change in Functional Magnetic Resonance Imaging from Baseline to 6 Weeks [ Time Frame: Measured pre-treatment (baseline) and post-treatment (at 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760212
|Contact: Paolo Sanzo, DScPTfirstname.lastname@example.org|
|Thunder Bay, Ontario, Canada, P7B 5E1|
|Contact: Paolo Sanzo, DScPT 807-343-8647 email@example.com|
|Contact: Simon Lees, PhD 807-766-7435 firstname.lastname@example.org|
|Sub-Investigator: Simon Lees, PhD|
|Sub-Investigator: Carlos Zerpa, PhD|
|Sub-Investigator: Erin Pearson, PhD|
|Sub-Investigator: Jane Lawrence-Dewar, PhD|
|Sub-Investigator: Wes Fidler, MD|
|Sub-Investigator: Bryan MacLeod, MD|
|Principal Investigator:||Paolo Sanzo, DScPT||Lakehead University|