Rheumatoid arthritis affecting the hands and wrists Musculoskeletal Diseases Rheumatoid arthritis affecting the hands and wrists
Conditions
Interventions
Participants will be randomly allocated to the intervention and control groups.
Intervention group: Standard care (joint protection advice and functional splinting) supplemented with an optimised ex
Sponsors
University of Warwick (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. People with RA 2. Those who meet the American College of Rheumatology clinical and immunological criteria, with pain and dysfunction of the hands and or wrist joints 3. Either not on a Disease-Modifying Anti-Rheumatic Drugs (DMARD), or who have been on a stable DMARD regimen, for three months or more
Exclusion criteria
Exclusion criteria: 1. Patients recovering from upper limb joint surgery, or fracture, in the previous six months 2. Patients on a waiting list for upper limb orthopaedic surgery 3. Patients who are pregnant 4. Aged less than 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 18/08/2011: The Michigan Hand Outcomes Questionnaire (MHQ) Overall hand function score over 12 months Previous primary outcome measure: The Arthritis Impact Measurement Scales (AIMS) 2, Finger and Hand function subscale at 0, 3 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/08/2009: 1. Michigan Hand Outcomes Questionnaire (MHQ) at 0, 4 and 12 months 2. MHQ pain subscale and Pain 'Troublesomeness' at 0, 4 and 12 months 3. Grip and pinch strength at 0, 4 and 12 months 4. Dexterity at 0, 4 and 12 months 5. Hand and wrist Range of motion at 0, 4 and 12 months 6. MCPJ Joint alignment at 0, 4 and 12 months 7. Joint tenderness and swelling at 0, 4 and 12 months 8. Disease activity at 0, 4 and 12 months 9. SF-12 at 0, 4 and 12 months 10. Self-efficacy at 0, 4 and 12 months 11. Treatment satisfaction at 4 and 12 months 12. Global change question 7 point Likert scale at 4 and 12 months 13. Adherence to home exercise questionnaire at 0, 4 and 12 months 14. Resource use questionnaire at 0, 4 and 12 months 15. EuroQol EQ-5D: Health Utility at 0, 4 and 12 months The above changes are in line with protocol V2 14/08/2009 Previous secondary outcome measures: 1. AIMS 2 Upper Limb function subscale at 0, 3 and 12 months 2. AIMS 2 Arthritis Pain Scale at 0, 3 and 12 months 3. Grip and pinch strength at 0, 3 and 12 months 4. Dexterity at 0, 3 and 12 months 5. Range of motion at 0, 3 and 12 months 6. Joint alignment at 0, 3 and 12 months 7. Joint tenderness and swelling at 0, 3 and 12 months 8. Disease activity at 0, 3 and 12 months 9. EuroQol EQ-5D at 0, 3 and 12 months 10. Adapted Michigan Hand Outcomes Questionnaire at 3 and 12 months 11. Global change question 7 point Likert scale at 3 and 12 months 12. Resource use questionnaire at 0, 3 and 12 months 13. EuroQol EQ-5D: Health Utility at 0, 3 and 12 months The following secondary outcome measure was added as of 10/07/2008: 14. Adherence to home exercise, assessed at 3 and 12 months | — |
Countries
United Kingdom
Outcome results
None listed