Fibromyalgia Clinical Trial
Official title:
A Study of the Effect of Rhythmic Sensory Stimulation on Fibromyalgia
Verified date | June 2018 |
Source | Mount Sinai Hospital, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Fibromyalgia is a chronic pain disorder associated with widespread pain that dramatically impacts patient's quality of life. The present research aims to determine the effectiveness of Rhythmic Sensory Stimulation with rhythmic gamma-frequency (30 - 120 Hz) acoustic-driven stimulation of mechanoreceptors in the body on the treatment of fibromyalgia. The proposed treatment involves 30 minutes of daily rhythmic vibroacoustic stimulation at gamma range, 5 days per week, for 5 weeks. 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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Wasser Pain Management Centre, Mount Sinai Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Mount Sinai Hospital, Canada | University of Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient Global Improvement Impression (PGI-I) | PGI-I is a global index that may be used to rate the response of a condition to a therapy. | 6 weeks | |
Other | Perceived treatment satisfaction assessed by a Modified version of the Glasgow Benefit Inventory | The Glasgow Benefit Inventory is a subjective post-interventional questionnaire especially developed to evaluate patient's perceived satisfaction with the treatment. | 6 weeks | |
Primary | Change of Fibromyalgia symptoms and severity from baseline assessed by the Revised Fibromyalgia Impact Questionnaire (FIQ) at 6 weeks | The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes, based on a 10 point scale. | Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) | |
Secondary | Change of sleep quality from baseline assessed by the Pittsburgh Sleep Quality Index (PSQI) at 6 weeks | The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time. | Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) | |
Secondary | Change of depression severity from baseline assessed by the Patient Health Questionnaire-9 (PHQ-9) at 6 weeks | The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module. | Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) | |
Secondary | Change in general quality of life from baseline assessed by the Quality of Life Enjoyment and Satisfaction questionnaire (Q-LES-Q-SF) at 6 weeks | The Quality of Life Enjoyment and Satisfaction questionnaire is a generic, self-reported quality of life measure assessing the physical health, subjective feelings, leisure activities, social relationships, general activities, satisfaction with medications and life-satisfaction domains. | Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) | |
Secondary | Change of pain severity from baseline assessed by Brief Pain Inventory - short form (BPI-SF) at 6 weeks | BPI-SF is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning based on a 10 point scale. | Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) |
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