ISRCTN21694164
Completed
N/A
A randomised controlled trial to evaluate the effectiveness of a combined education and pool-based exercise programme and usual care in the treatment of patients with fibromyalgia syndrome
niversity of Ulster (UK)0 sites156 target enrollmentOctober 31, 2005
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Ulster (UK)
- Enrollment
- 156
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Women between the ages of 18 and 65 years. (If of childbearing age, state that they are not pregnant.)
- •2\. Fulfil the 1990 American College of Rheumatology diagnostic criteria for fibromyalgia (i.e. at least a 3\-month history of widespread pain in conjunction with tenderness at 11 of 18 specific tender points)
- •3\. Able to attend and participate in a 6 week programme of moderate intensity exercise in a hydrotherapy pool
- •4\. Diagnosed by a consultant rheumatologist with FMS within the previous 3 months
- •5\. Give written informed consent to take part in the trial
- •6\.Literate
Exclusion Criteria
- •1\. Have concomitant medical illness (e.g. ischaemic heart disease, cerebrovascular accident) that would make participation in an exercise class unsafe
- •2\. Are involved in ongoing litigation involving FMS
- •3\. Score of less than 3 on a 10\-point visual analogue scale (VAS) for pain (a low level cut off will avoid floor effects)
- •4\. Have received physiotherapy within the last 3 months for FMS
Outcomes
Primary Outcomes
Not specified
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