Specialty: Musculoskeletal disorders, Primary sub-specialty: Elective orthopaedic surgery
Conditions
Interventions
Participants are randomised to one of three groups.
Group 1: Participants undertake the self-management package alone for eight weeks. The self management package includes being given
a personal splint wearing guide which is used to facilitate consideration of barriers and enablers to wearing the splint
a splint wear diary to record how much the splint is worn
and a splint wear hours guide which explains when to wear the splint.
Group 3: Participants undertake the self-management package plus thumb splint (DM Orthotics Thumb Sleeve or DM Or
and a splint wear hours guide which explains when to wear the splint.
Participants in all groups are followed up at 4, 8 and 12 weeks.
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 30 years and over 2. At least moderate AUSCAN hand pain (AUSCAN Hand pain score >5) and functional hand disability (AUSCAN hand functional disability score >9) 3. One of the following: 3.1. Hard tissue enlargement of the first carpometacarpal joint (CMCJ) 3.2. Squaring of the thumb base 3.3. Pain that worsens when pinching 3.4 Pain that worsens on span grip (eg opening a jar) 3.5. Crepitus on movement 3.6. Reduction in thumb base range of movement 3.7. Positive thumb adduction provocation test 3.8. Positive thumb extension provocation test 3.9. Pain on palpation of the dorso-radial aspect of the thumb CMCJ 4. No other household member participating in the trial 5. Able to give written informed consent 6. Available to attend Occupational Therapy/Physiotherapy/Hand Therapy sessions
Exclusion criteria
Exclusion criteria: 1. Consultation with therapy department or treatment for this thumb problem (excluding pain killers and anti-inflammatories) in the previous 6 months 2. Intra-articular joint injection to wrist, fingers or thumb in the previous 2 months 3. Fractures or significant injury or surgery to the wrist or hand within the previous 6 months 4. Red flags e.g. history of serious illness or disease (e.g. rheumatoid arthritis, psoriatic arthritis), progressive neurological signs, acute swollen joint 5. Diagnosis of dementia or significant disorder likely to affect communication 6. Already received thumb splints for thumb base OA 7. Skin disease that may interfere or contraindicate splint wear 8. Participants of a drug or medical device trial in the last 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hand pain is measured uisng the AUSCAN index for hand pain at baseline, 8 and 12 weeks Updated 01/03/2019 to remove the 4-week questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall response to treatment is measured using the OMERACT responder criteria that combines: 1.1. Global assessment of change for thumb base problem rating from “completely recovered” to “very much worse” on a 5 point ordinal rating scale 1.2. AUSCAN hand function index 1.3. AUSCAN hand pain index at baseline, 8 and 12 weeks 2. Satisfaction with hand function over the past week is measured using an ordinal rating scale at baseline, 8 and 12 weeks 3. Hand pain severity over the last week is measured using an ordinal rating scale at baseline, 8 and 12 weeks 4. Thumb pain over the last week is measured using an ordinal rating scale at baseline, 8 and 12 weeks 5. Ability to take part in leisure activities is measured using The Disability of the Arm, Shoulder and Hand Questionnaire (leisure section only, 3 ordinal questions) at baseline, 8 and 12 weeks 6. Generic Quality of Life is measured using the SF12v2 at baseline, 8 and 12 weeks 7. General health is measured using the EuroQol 5 Dimensions 5-Levels questionnaire at baseline, 8 and 12 weeks 8. Self-efficacy is measured using the Arthritis Self-efficacy pain subscale at baseline, 8 and 12 weeks 9. Hand function is measured using the clinician assessed Grip Ability Test at baseline, 4 and 8 weeks 10. Health care resource use and associated costs are measured at 8 and 12 weeks. Costs included will be: provision of intervention splints, hospitalisation and associated length of stay, outpatient and A&E visits and primary care visits (both in practice and at home from general practitioners, nurses and community therapists). Resource use will be valued using readily available NHS Reference costs, UK costs of health and social care and the list prices in the British National Formulary. 11. Work and | — |
Countries
United Kingdom
Outcome results
None listed