Fibromyalgia Clinical Trial
Official title:
Effect of Anti-Depressants vs Physiotherapy in Management of Fibromyalgia Syndrome: What Predicts a Clinical Benefit?
To compare the efficacy of physiotherapy and anti-depressants in disability reduction in patients of Fibromyalgia syndrome.
Status | Completed |
Enrollment | 175 |
Est. completion date | April 2008 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Patient's between 18-60 yrs, belonging to either sex. With symptoms of chronic muscular pain of at least 12 weeks (that may or may not be consecutive) who fulfill the American College of Rheumatology (ACR) criteria for the diagnosis of Fibromyalgia Exclusion Criteria: - Patients of age group more than 60 yrs and below 18 years - Pregnant or lactating females. - Patients with a history of trauma. - Patients with severe co morbid illness which prevents physical activity (for example, cardiovascular problems) - Patients with the presence of specific medical disorders which require immediate treatment (for example, fractures, infectious diseases), - Patients with associated neurological abnormality |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Mahatma Gandhi Institute of Medical Sciences | Sevagram | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Mahatma Gandhi Institute of Medical Sciences |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in FIQ score from the baseline | Two years | No | |
Secondary | Reduction in Tender point score | Two years | No | |
Secondary | Reduction in Brief psychiatric rating score | Two Years | No |
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