Musculoskeletal Diseases: Rheumatoid arthritis (RA) Musculoskeletal Diseases Rheumatoid arthritis (RA)
Conditions
Interventions
Men and women aged 18 years or older with RA (meeting American College of Rheumatology criteria) attending the Rheumatology out-patient department will be invited to participate. Many patients with RA
Sponsors
Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
Eligibility
Inclusion criteria
Inclusion criteria: a. Invitation - potential volunteers will be invited to participate when they attend their Rheumatology out-patient appointment sessions. They will be provided with a "Patient Information Leaflet" and a short screening Questionnaire with a section to state their interest in participation b. Consent - Informed consent for participation in the study will be sought from all volunteers and consent forms will be completed. A copy of this form will be retained by each patient. c. Patient Selection: Inclusion criteria: 1. Ability to understand the purpose of the study, give informed consent in writing and follow simple instructions 2. Age >18 years 3. Stable disease modifying drugs for 6 weeks before study entry 4. No injected steroids 4 weeks prior to study entry 5. Stable non-steroidal anti-inflammatory drugs for 2 weeks before entry 6. No surgery 3 months preceding study or planned surgery within 3 months of entry 7. Functional class I, II, III
Exclusion criteria
Exclusion criteria: 1. Patients who have received physiotherapy or hydrotherapy in the past 6 months 2. Any medical condition that in the opinion of the investigators would cause the study to be detrimental to the patient 3. Known chlorine sensitivity 4. Open or infected skin wound 5. Poorly controlled epilepsy 6. Incontinence of faeces 7. Weight >16 stones (102 kg) - inability to meet emergency procedures in our hydrotherapy pool 8. Pregnancy or breast-feeding 9. Fear of water precluding hydrotherapy 10. Inability to communicate with therapist effectively 11. Unlikely to comply with therapy in the opinion of a physician 12. Known carriage of methicillin- resistant Staphylococcus aureus (upper respiratory tract)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A research assistant blind to treatment allocation will collect initial and final outcome measurements. Primary Outcome measure: the proposed primary outcome measures change in self-rated global impression, a validated measure of treatment effect. This measure has previously been used in clinical trials of exercise in fibromyalgia and chronic fatigue syndrome. Effect of treatment is measured as change on a 7-point scale ranging from 1 (very much worse) to 7 (very much better). Participants scoring 6 or 7 will be regarded as responders and others as non-responders. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will include: - Pain measured on a 10 cm visual analogue scale - Physical function based on the health assessment questionnaire (HAQ score), 10 metre walk speed and quality of life measured by the first part of the Euroqol EQ-SD questionnaire that records problems in five domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Tertiary outcomes: We propose to compare cost-effectiveness of hydrotherapy and land exercises by using data from secondary outcome measures collected, particularly utility scores calculated from EQ-SD and nationally available sources on the cost of health services. | — |
Countries
United Kingdom
Outcome results
None listed