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Treatment and Assessment of Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02760212
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Lakehead University

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Radial Shockwave Therapy Other: Placebo Comparator: Group 2 - Placebo Group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Physical Approaches to the Management of Fibromyalgia - A Multidisciplinary Approach
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Lakehead University
Thunder Bay, Ontario, Canada, P7B 5E1
Sponsors and Collaborators
Lakehead University
Investigators
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Principal Investigator: Paolo Sanzo, DScPT Lakehead University

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Responsible Party: Lakehead University
ClinicalTrials.gov Identifier: NCT02760212     History of Changes
Other Study ID Numbers: LakeheadU
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Clinical Study Report (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.
URL: https://tbay.research@gmail.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lakehead University:
Shockwave therapy
fMRI
blood biomarkers
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases