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

Completed

• Conditions: Fibromyalgia; Musculoskeletal Diseases

• Registration Number: ISRCTN21694164
• Lead Sponsor: niversity of Ulster (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-31
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 156

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified