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The SMOotH Study - Self Management in Osteoarthritis of the Hand: a randomised controlled trial in the community

Self management, joint protection education and exercises in hand osteoarthritis: a randomised controlled trial in the community

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33870549
Enrollment
252
Registered
2008-01-23
Start date
2007-06-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Hand osteoarthritis Musculoskeletal Diseases Hand osteoarthritis

Interventions

Group 1 - usual care: Group 1 will receive information on general practice (GP) headed notepaper to continue with their own self-management approaches, which they will be asked to record in a diary,

Sponsors

Keele University (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Males and females aged 50 years and over 2. Fulfilling the American College of Rheumatology (ACR) definition of symptomatic hand OA, or symptomatic thumb base OA on clinical assessment 3. No other household member participating in the trial 4. Ability to understand and capable of giving written informed consent 5. Available to attend OT classes if allocated to receive OT intervention 6. Able to give informed consent

Exclusion criteria

Exclusion criteria: 1. Consultation or treatment for this hand problem in the previous 6 months including: 1.1. Intra-articular joint injection to wrist, fingers or thumb 1.2. Fractures or significant injury or surgery to the wrist or hand 1.3. Consultation for this hand problem with an OT or physiotherapist 2. Red flags e.g., history of serious illness or disease (e.g., rheumatoid arthritis, psoriatic arthritis, stroke), progressive neurological signs, acute swollen joint 3. Minimal pain and function on the primary outcome measures (Australian/Canadian hand outcome score [AUSCAN] pain less than 5, function less than 9)

Design outcomes

Primary

MeasureTime frame
The primary outcome will combine the pain and function subscales of the Australian/Canadian hand osteoarthritis measure (AUSCAN) with a global assessment of improvement (6 point scale: completely better, much better, better, same, worse, much worse) according to the Osteoarthritis Research Society International (OARSI)/Outcome Measures in Rheumatology (OMERACT) criteria to determine whether each individual is a 'responder' to treatment. Outcome measures will be completed at baseline, 3, 6 and 12 months. The primary end point will be 6 months.

Secondary

MeasureTime frame
1. Global assessment of change of hand problem at 3, 6 and 12 months 2. Individual subscales of the AUSCAN (Pain, stiffness and function) at recruitment, baseline, 3, 6 and 12 months 3. Hand pain manikin at recruitment, 3, 6 and 12 months. Participants are asked if they have had any ache or pain that has lasted for one day or longer in their hands. Individuals responding positively to this question are then asked to shade in a diagram of the hands (backs and palms) indicating where this ache or pain has been experienced. 4. Average pain severity over the past 3 days, assessed at baseline, 6-month clinic assessment and at 12 months 5. Severity rating of participant nominated main functional problem over the past 3 days, assessed at baseline and 6-month clinic assessment, 3 and 12 months 6. Frustration related to hand disability, assessed at baseline, 3, 6 and 12 months 7. Participation restriction, assessed at recruitment, 3, 6 and 12 months 8. Quality of life: 8.1. EuroQol EQ-5D instrument at baseline, 3, 6 and 12 months 8.2. 12-item short form version 2 (SF-12v2) questionnaire at recruitment, 3, 6 and 12 months 9. Generic measure of disability, assessed by SF-12v2 at recruitment, 3, 6 and 12 months 10. Self-efficacy in relation to pain (Arthritis Self-Efficacy pain subscale), assessed at baseline, 3, 6 and 12 months 11. Illness perceptions, measured by Illness Perceptions Questionnaire Revised (IPQ-R) modified for hand OA, assessed at recruitment, baseline, 3, 6 and 12 months 12. Side-effects of treatment and adverse events 13. Co-interventions: 13.1. From consultation download: follow-up visits to the GP, prescription of medication including non-steroidal anti-inflammatory drugs (NSAIDs), referral for other treatment such as surgery 13.2. From self-reported questionnaires: self-help remedies, contacts with private health care, over the counter medicines, use of hand splints 14. Satisfaction with care, assessed at 3 and 6 months 15. Self-reported behaviour chan

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026