None listed
Conditions
Brief summary
Evidence for the use of splints to reduce pain and improve function and quality of life in thumb base osteoarthritis (OA) is sparse and of poor quality despite conditional recommendations for their use by international guidelines. This study aims to test the feasibility of study design parameters including, the recruitment strategy and assessments for time and acceptability, implementation and evaluation of 'usual care', the intervention procedures including evaluation of adherence, and outcome change over time, to inform a future full-powered randomized controlled trial. The current study will aim to recruit 30 adults with thumb base OA, randomised to two groups: splint intervention or control group. Participants will be recruited from community and health (primary care and DHB) settings in two centres (Dunedin and Invercargill). Thumb base OA is a highly prevalent condition that causes pain, limits function and impacts on health-related quality of life. If shown to be effective in the subsequent study, soft off-the shelf splints would be a good first-line, non-pharmacological, non-surgical option for thumb base OA that could easily be prescribed by physiotherapists, occupational therapists, GP or other physician or health professional, or accessed directly by patients, to reduce pain and functional limitations and improve health-related quality of life in people with thumb base OA.
Interventions
Participants randomized to the intervention group will be fitted with a soft neoprene hand-based splint (Procool T/R Splint Bound, @Therapy) and instructed to wear the splint 20 hours out of 24 for a total duration of 4 weeks, in addition to standardised usual care. An explanation of the rationale and wearing schedule for the splint will be given. A simple behavioural intervention will accompany the splint prescription, comprising dedicated time for skill acquisition and practice within the trea
Participants randomized to the intervention group will be fitted with a soft neoprene hand-based splint (Procool T/R Splint Bound, @Therapy) and instructed to wear the splint 20 hours out of 24 for a total duration of 4 weeks, in addition to standardised usual care. An explanation of the rationale and wearing schedule for the splint will be given. A simple behavioural intervention will accompany the splint prescription, comprising dedicated time for skill acquisition and practice within the treatment session for donning and doffing the splint; providing feedback and encouragement; and fostering self-efficacy through problem solving to incorporate the splint in everyday life. Minor modifications may be made to the splint (shorten or alter shape of the thumb exit space by cutting; alter length of strap through web space or wrist using NRX Strap, @Therapy) for optimal fitting while maintaining splint aesthetic. Two splints will be issued – one to wash, one to wear. Splint intervention procedure will comprise a one-off face-to-face consult in a health setting in two centres (School of Physiotherapy, Dunedin, and Southland Hospital, Invercargill), anticipated to take 20 minutes per participant. A registered physiotherapist and hand therapist with 17 years clinical experience (Principal Investigator) will implement the intervention. If participants in either group require any assistance during the 4-week treatment period, they may contact the research administrator for the treating therapist to make an arranged call to the participant. If any issue is unable to be resolved by telephone consult, then a follow up treatment session will be arranged. Measures to optimize adherence to the intervention include: ensuring the splint is comfortable, well fitted and aesthetically acceptable; advising how to successfully adapt activities without compromising the splint regime; establishing a trusting relationship by providing education and rationale for treatments; catering for different learning styles; and implementing simple behavioural intervention. Actual adherence will be measured by a daily patient log to record splint wearing time. The clinical research administrator will telephone or text reminders on a weekly basis to remind the participant to complete the daily log. Quality and consistency of implementation of the intervention will be monitored by a senior co-investigator using a tailored quality audit tool.
Sponsors
Miranda Buhler
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• English-speaking adults with thumb carpometacarpal joint osteoarthritis • Aged 40+ years • Answer “yes” to the question, “Have you experienced aching, discomfort, pain and/or stiffness in or around the joint at the base of either thumb on most days for at least 1 month (15 or more days of the month) during the past year?” and have no other specific diagnosis. • Minimum severity pain VAS 4/10 • Minimum score FIHOA 6/30 • Tenderness on palpation of the trapeziometacarpal joint • Positive grind test OR traction-shift test OR observable “step-off” sign. • Give written informed consent
Exclusion criteria
• Thumb non-symptomatic for the past month • Previous surgery of the symptomatic joint • Steroid injection in the past 6 months • Previous splint intervention prescribed by health professional • Concurrent rheumatoid arthritis or any other significant inflammatory or autoimmune conditions affecting the hand such as scleroderma, systemic lupus erythematosus and psoriatic arthritis, or another kind of chronic pain syndrome or metabolic disorder, such as fibromyalgia, diabetic neuropathy, or gout.
Outcome results
None listed