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Trial record 53 of 138 for:    fibromyalgia | Open Studies | Interventional Studies

Treatment and Assessment of Fibromyalgia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2016 by Lakehead University
Sponsor:
Information provided by (Responsible Party):
Lakehead University
ClinicalTrials.gov Identifier:
NCT02760212
First received: April 20, 2016
Last updated: April 29, 2016
Last verified: April 2016
  Purpose

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 Intervention Phase
Fibromyalgia
Device: Radial Shockwave Therapy
Other: Placebo Comparator: Group 2 - Placebo Group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Physical Approaches to the Management of Fibromyalgia - A Multidisciplinary Approach

Resource links provided by NLM:


Further study details as provided by Lakehead University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Subject pain will be rated using a VAS by the participant for the 3 most painful regions.


Secondary Outcome Measures:
  • Focus Group Qualitative Themes Identified from Transcripted Survey Responses [ Time Frame: Post-treatment (at 6 weeks) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: November 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02760212

Contacts
Contact: Paolo Sanzo, DScPT 807-343-8647 psanzo@lakeheadu.ca

Locations
Canada, Ontario
Lakehead University Recruiting
Thunder Bay, Ontario, Canada, P7B 5E1
Contact: Paolo Sanzo, DScPT    807-343-8647    psanzo@lakeheadu.ca   
Contact: Simon Lees, PhD    807-766-7435    simon.lees@nosm.ca   
Sponsors and Collaborators
Lakehead University
Investigators
Principal Investigator: Paolo Sanzo, DScPT Lakehead University
  More Information

Responsible Party: Lakehead University
ClinicalTrials.gov Identifier: NCT02760212     History of Changes
Other Study ID Numbers: LakeheadU 
Study First Received: April 20, 2016
Last Updated: April 29, 2016
Health Authority: Canada: Ethics Review Committee
Individual Participant Data  
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.

Keywords provided by Lakehead University:
Shockwave therapy
fMRI
blood biomarkers

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 28, 2016