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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN21694164
Enrollment
156
Registered
2005-10-31
Start date
2003-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia Musculoskeletal Diseases Fibromyalgia

Interventions

Intervention Group: Patients allocated to the intervention group will receive a package of treatment consisting of: 1. A series of lecturers/workshops aimed at addressing patients? attitudes, beliefs

Sponsors

University of Ulster (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Fibromyalgia Impact Questionnaire.

Secondary

MeasureTime frame
1. Tender point count and Total myalgic score 2. The 6-minute walk test 3. The Arthritis Impact Measurement Scales II (AIMS2) 4. McGill Pain Questionnaire

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026