This research looks at the development and pilot testing of therapy intervention to relieve pain and improve function in people with thumb osteoarthritis. The research will design and conduct a pilot trial, comparing occupational therapy treatment; occupational therapy treatment plus an immobilising thumb splint and occupational therapy treatment plus a mobilising splint in people with thumb base osteoarthritis.
Clinical Benefits
The findings from the study will be used to design a full trial into the effectiveness of thumb splints in osteoarthritis. As patients will be involved in the design and development of the intervention and measurement outcomes this will ensure that the trial will be guided by what patients living with thumb base OA consider important. This will also help improve therapy approaches. Future patients will also benefit from a research design that has included patients' feedback and input throughout the study design.
Background
Context: Clearly explain the context of your study: the disease and its clinical impact and the need for further diagnostic, screening, treatment or preventative options
Osteoarthritis (OA) is the leading cause of musculoskeletal pain and disability in adults aged 50 years and over. Twenty percent of the population aged over 55 years have thumb base OA. Thumb base OA has the potential to have more lasting pain, work disability, reduction in quality of life and overall function than other hand sites affected by OA. Thumb base OA is one of the most common sites of OA and pain, yet most research considers the lower limb. The economic burden of OA is high. With an ageing population and increased life expectancy it is important to establish effective interventions.
The need for further investigation
Two authoritative expert reports detail a lack of evidence to support non-surgical interventions for hand OA. Thumb base splints are recommended and provided for people but there is limited evidence to support their effectiveness.
1. What are patients’ perceptions about their thumb pain and the most effective thumb splint for thumb base osteoarthritis?
2. What is the consensus opinion of both patients and collaborating clinicians about the most appropriate occupational therapy programme and splint trial intervention?
3. What trial procedures are most effective for designing a full clinical and cost effectiveness RCT of thumb base splinting?
Provide some justification for your study. Include evidence from the literature, stakeholder consensus and evidence from pilot studies. Why does this study hold particular promise for treatment or care?
Evidence from the literature
Previous splint trials have been small over short periods of time with no control group [1-3]. None has addressed outcomes that patients have defined as important to them. No splint design has been identified as superior [1, 4]. The most recent trial has considered splint protocols that are not used in the UK, and with potentially biased assessment [5]. This trial addresses very specific and different questions from previous ones.
Justification for study
The arc OA Clinical Studies Group and the National Institute for Clinical Excellence have identified the effectiveness of splints in OA as a national research priority.
Stakeholder consensus
We have established a national clinical advisory group of 30 occupational therapists for this project who have been consulted throughout. Feedback has been provided throughout from the Keele Primary Care Representative Users Group, our Arthritis Research UK patient representative and educational consultant project advisers. We also have a wide team of expert advisers for this project who have contributed to this project design.
Evidence from pilot studies
The applicants have an excellent track record of conducting effective and successful high quality trials. Our trial will replicate successful design and recruitment strategies already implemented by this team and UK collaborators [9-13]. We have demonstrated that in one centre alone (Arthritis Research UK National Primary Care Centre) we have recruited 257 participants in less than 12 months with hand OA to a trial delivering an occupational therapy intervention. Over 90% of this trial population fulfils the criteria for this present proposed trial.
Promise for patient care
This work will form the basis for a full RCT. This exploratory work will answer what is important for patients with thumb base OA, what outcomes are most appropriate to be included and what NHS trial intervention is feasible and practical for a fully powered subsequent RCT. This study will build upon previous Arthritis Research UK funded work conducted on the effectiveness of OT intervention and National and European guidelines will help determine an evidence-based package of optimal occupational therapy care for people with thumb base OA.
Is this a completely novel and untried approach?
Is there other research supporting your approach which has been successfully applied in other areas which have led to clinical benefit?
The use of a development phase to include patient involvement in the trial design is novel and timely.
Consensus (Delphi) Study
Patient and clinician input and consensus on the interventions to be tested for the trial is novel. A consensus study is currently being undertaken at the Arthritis Research UK National Primary Care Centre, Keele University, to determine a model OA consultation in primary care. Experiences from this study will inform the protocol for the lay consensus study.
This research combines exciting patient focused developmental work alongside tried and tested procedures for examining the effectiveness of a routinely used intervention for thumb base OA. If thumb splints were shown to be clinically and cost effective then there would be demonstrable benefit for a large proportion of people with OA.
Full details of the proposed trial/study design
Our study is a 2-year development study for a full RCT into the clinical and cost effectiveness of a thumb based RCT. Within this time we will conduct:
A forum with patients with thumb base OA.
A Delphi study with patients and collaborating clinicians to refine and define the optimal OT care and splint intervention.
A one-month pilot study of the trial intervention.
A Patient Forum
The randomised controlled trial is of a complex intervention and as recommended by the MRC [26] we will undertake an initial patient-involvement component to ensure the delivery of acceptable interventions that reflect patients' experiences of splint wear and existing coping strategies for thumb base OA. In addition we shall draw on this work to improve the design of the trial, including recruitment practices, engagement with the trial through the promotion of shared-decision making and to identify relevant outcome measures. This will address issues surrounding the acceptability and expectations of the thumb base splint options, suggested content of a package of splint care and strategies to maximise outcome expectations and satisfaction with care.
The Delphi Study
A Delphi study will be conducted to: agree and define the design of appropriate splints; obtain a consensus of the trial splint design options to include in the splint intervention arm and a consensus of thumb base OA optimal NHS OT care. We will include patients and clinical OT representatives within this Delphi study. Adams and colleagues in the NIHR SARAH hand exercise trial have demonstrated a consensus approach to refining a hand rheumatoid arthritis intervention for a large RCT is feasible and successful. A Delphi study with lay participants is currently being implemented in the Arthritis Research UK National Primary Care Centre (Arthritis Research UK NPCC), Keele University and experiences from this work will inform the Delphi study with patients.
The Pilot Study
A pilot of the splint interventions, recruitment procedures and optimal care intervention will be conducted in year two of this development phase. This pilot will be run in the Southampton, Stafford, Cheshire hubs and include Derby with six OT sites with a one month self-report follow up to test training protocols for therapists' splinting and recruitment procedures.
J Adams, Jane Burridge, Maria Stokes
Krysia Dziedzic (Keele)
Nigel Arden (LINK)
Alison Hammond (Salford)
Rachael Gooberman –Hill (Bristol)
Arthritis Research UK
Musculoskeletal
Rheumatology
Hand Therapy