Fibromyalgia Clinical Trial
Official title:
Healing Through Affective Self-Awareness in Fibromyalgia: a Randomized Controlled Trial
Verified date | October 2016 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The investigators are studying whether a brief three-session mind-body workshop helps people with fibromyalgia. The investigators hypothesize that this workshop will significantly improve pain and other symptoms, compared to usual care.
Status | Completed |
Enrollment | 66 |
Est. completion date | November 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - fibromyalgia, as defined by American College of Rheumatology 1990 criteria. - at least 18 years of age. - have access to transportation to and from Providence Hospital, Southfield, MI. Exclusion Criteria: - co-morbid medical conditions capable of causing a worsening of physical functional status independent of FM, including morbid obesity, autoimmune diseases, cardiopulmonary disorders (e.g. angina, congestive heart failure, COPD, chronic asthma), uncontrolled endocrine or allergic disorders (e.g. thyroid dysfunction, Type I diabetes), pregnancy, and malignancy within the preceding 2 years. - any present psychiatric disorder involving a history of psychosis (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder etc.), post-traumatic stress disorder, current suicide risk or history of suicide attempt, or substance abuse within 2 years. Note: Subjects with mood or anxiety disorders otherwise will not be excluded. - changes in medication regimen within one month prior to enrollment. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | St. John Providence Hospital | Southfield | Michigan |
Lead Sponsor | Collaborator |
---|---|
Mike Hsu | Blue Care Network of Michigan, St. John Providence Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in average pain according to the Brief Pain Inventory | 6 months | No | |
Secondary | Change in Multi-dimensional Fatigue Inventory | 6 months | No | |
Secondary | Medical Outcomes Study sleep subscale | 6 months | No | |
Secondary | Perceived Stress Scale | 6 months | No | |
Secondary | SF-36 Physical Functional Status | 6 months | No | |
Secondary | Profile of Mood States | 6 months | No | |
Secondary | Tender point count | 6 months | No | |
Secondary | Dolorimeter tender point score | 6 months | No | |
Secondary | Ascending and Multiple Random Staircase thumbnail sensitivity thresholds | 6 months | No |
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