Clinical Trials

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Clinical trials are an important part of fibromyalgia research, and at any given time, there are hundreds of clinical trials being conducted. A quick review of the U.S. National Institutes of Health website, ClinicalTrials.gov, shows the following trials currently recruiting trial subjects.
 
Remember:  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 clinical studies, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
 
USA, Massachusetts
A Brain Imaging Study of Fibromyalgia
 
Purpose

Healthy adults and adults diagnosed with fibromyalgia, aged 18-50, are needed for a research study investigating whole brain functional Magnetic Resonance Imaging to assess cerebral blood flow and functional connectivity change in fibromyalgia patients.
 
Inclusion Criteria for fibromyalgia patients

  • Volunteers 18-50 years of age.
  • Fibromyalgia for at least the past 3 months, as determined by the referring physician.
  • At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures. 

Exclusion Criteria for fibromyalgia patients

  • Specific causes of pain (e.g., cancer, fractures, spinal stenosis, infections)
  • History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
  • Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy. 

Inclusion Criteria for healthy adults

  • Volunteers 18-50 years of age.
  • At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures. 

Exclusion Criteria for healthy adults

  • Chronic and acute pain (ex. Fibromyalgia).
  • History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
  • Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857219
 
Contact:
Domenic Minicucci, BS
617-643-7947
dminicucci@partners.org

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Canada
A Study of the Effect of Rhythmic Sensory Stimulation and Music on Fibromyalgia  
 
Purpose

Fibromyalgia is a chronic pain disorder associated with widespread pain that dramatically impacts patient's quality of life. Its exact cause has not yet been identified, however recent studies have indicated that fibromyalgia is associated with significant imbalance of the connectivity within brain networks associated with pain, decreased functional connectivity in the descending pain-modulating system, and increased activity in the pain matrix related to central sensitization. It has been suggested, therefore, that treatments that induce coherent neuronal activity, and/or stimulate synchronization of dysregulated brain circuitry, have significant benefits, improving pain management and enhancing patient's quality of life.
 
Rhythmic Sensory Stimulation (RSS) is an example of a non-invasive treatment that is thought to indirectly stimulate neuronal coherence. The present research proposal aims to determine the effectiveness of Rhythmic Sensory Stimulation with 40 Hz sound on the treatment of fibromyalgia. The proposed treatment involves 30 minutes of daily rhythmic vibroacoustic stimulation at 40 Hz, 5 days per week, for 5 weeks. The treatment is self-administered by the patients at home with the Sound Oasis Vibroacoustic Therapy System (VTS) 1000 portable device. Measures of pain severity, fibromyalgia symptoms, sleep quality, and depression will be compared before and after treatment between the treatment and control groups.
 
The results of the present study will help to better understand the effectiveness of Rhythmic Sensory Stimulation to the treatment of chronic pain disorders, such as fibromyalgia, and contribute to the development of future studies to investigate the neural driving effects of therapies based on Rhythmic Sensory Stimulation.
 
Both male and females of 18 years of age or older are eligible for this study.
 
Inclusion Criteria:

  • Clinical diagnosis of fibromyalgia conducted by the medical staff at Wasser Pain Management Centre;
  • Ability to read and write English adequately;
  • Have satisfactory hearing bilaterally (self-reported);
  • Have the ability to operate the supplied device.

Exclusion Criteria:

  • Acute and active inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis, autoimmune disease);
  • Unstable medical or psychiatric illness;
  • History of psychosis, epilepsy, seizures;
  • Pregnancy or breast feeding;
  • Hemorrhaging or active bleeding;
  • Thrombosis, angina pectoris;
  • Heart diseases, such as hypotension, arrhythmia, pacemaker;
  • Substance abuse in the last year;
  • Recently prolapsed vertebral disc;
  • Recovering from a recent accident with back or neck injury. 

Please refer to this study by its ClinicalTrials.gov identifier: NCT02493348
 
Contacts
Denise Paneduro, MA
416-586-4800, ext. 2082
DPaneduro@mtsinai.on.ca
 
Thenille Braun Janzen, PhD
Thenille.braunjanzen@utoronto.ca

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England
Self Soft Tissue Therapy for Fibromyalgia Syndrome (FMS)
 
Purpose

The main aims of this preliminary research are to determine if combined self-soft tissue therapy (SSTT) alongside an established 6 week FMS Coping Skills Programme (FCSP) is a feasible and acceptable treatment approach for FMS. All participants on the six week FCSP will be randomly allocated to a control (FMS Coping Skills Programme) or intervention group (FMS Coping Skills Programme plus SSTT). All participants will be assessed for outcome measurements at the start of the feasibility study, at six weeks and three months after completion.
 
This feasibility study hypothesis is that the SST approach will be acceptable to FMS patients and that the combined 6 week FCSP (hands off) and SSTT (hands on) will be beneficial. This feasibility study will inform a larger randomized controlled trial (RCT) on this combined treatment approach to FMS.
 
Inclusion Criteria:

  • Clinical diagnosis of fibromyalgia conducted by the medical staff at Wasser Pain Management Centre;
  • Ability to read and write English adequately;
  • Have satisfactory hearing bilaterally (self-reported);
  • Have the ability to operate the supplied device. 

Exclusion Criteria:

  • Acute and active inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis, autoimmune disease);
  • Unstable medical or psychiatric illness;
  • History of psychosis, epilepsy, seizures;
  • Pregnancy or breast feeding;
  • Hemorrhaging or active bleeding;
  • Thrombosis, angina pectoris;
  • Heart diseases, such as hypotension, arrhythmia, pacemaker;
  • Substance abuse in the last year;
  • Recently prolapsed vertebral disc;
  • Recovering from a recent accident with back or neck injury. 

Male and females of 18 years of age or older are eligible for this study.
 
Please refer to this study by its ClinicalTrials.gov identifier: NCT02881411
 
Contacts:
Rob M. Grieve, PhD
0044117 328 8896
Rob.Grieve@uwe.ac.uk
 
Leigh Taylor
0044117 328 1170
Leigh.Taylor@uwe.ac.uk

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Have you participated in a cinical trial?  Tell us about your experience in the comments below.   

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