The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis

Adams, Jo; Barratt, Paula; Arden, N K; Bouças, Sofia Barbosa; Bradley, Sarah; Doherty, Michael; Dutton, Susan; Dziedzic, Krysia; Gooberman-Hill, Rachael; Hislop-Lennie, Kelly; Greenyer, Corinne Hutt; Jansen, Victoria; Luengo-Fernández, Ramón; Meagher, Claire; White, Peter; Williams, Mark A.

doi:10.1136/bmjopen-2018-028342

Cited by 9 publications

(10 citation statements)

References 48 publications

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“…(Ref:16/SC/0188) and monitored by Independent Trial Steering and Data Monitoring Committees (Supplementary File 2). The trial was registered (ISRCTN 54744256) and the protocol published [10].…”

Section: Design Overviewmentioning

confidence: 99%

“…Participants were randomised to receive one of three treatments, each delivered over an 8 week period, specifically: a) SSM: A supported self-management programme (Supplementary File 4) [10], based on clinical evidence [13], [14], [15], [16] national consensus [17] [18], and the trial's pilot study [19].…”

Section: Interventionsmentioning

confidence: 99%

“…The splints chosen were informed following patient and clinician consultation [17], the pilot study [19] and grant funder feedback. Splints were prescribed using a splint decision protocol (Supplementary File 5) [10], a discussion with therapists around facilitators and barriers to splint wear, a splint wear diary and wear/care instructions (Supplementary File 4) [10].…”

Section: Interventionsmentioning

confidence: 99%

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The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial

Rombach

Dutton

2020

Rheumatology

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Objectives To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint OA (BTOA). Methods A pragmatic, multicentre parallel group randomized controlled trial at 17 National Health Service (NHS) hospital departments recruited adults with symptomatic BTOA and at least moderate hand pain and dysfunction. We randomized participants (1:1:1) using a computer-based minimization system to one of three treatment groups: a therapist supported self-management programme (SSM), a therapist supported self-management programme plus a verum thumb splint (SSM+S), or a therapist supported self-management programme plus a placebo thumb splint (SSM+PS). Participants were blinded to group allocation, received 90 min therapy over 8 weeks and were followed up for 12 weeks from baseline. Australian/Canadian (AUSCAN) hand pain at 8 weeks was the primary outcome, using intention to treat analysis. We calculated costs of treatment. Results We randomized 349 participants to SSM (n = 116), SSM+S (n = 116) or SSM+PS (n = 117) and 292 (84%) provided AUSCAN Osteoarthritis Hand Index hand pain scores at the primary end point (8 weeks). All groups improved, with no mean treatment difference between groups: SSM+S vs SSM −0.5 (95% CI: −1.4, 0.4), P = 0.255; SSM+PS vs SSM −0.1 (95% CI: −1.0, 0.8), P = 0.829; and SSM+S vs SSM+PS −0.4 (95% CI: −1.4, 0.5), P = 0.378. The average 12-week costs were: SSM £586; SSM+S £738; and SSM+PS £685. Conclusion There was no additional benefit of adding a thumb splint to a high-quality evidence-based, supported self-management programme for thumb OA delivered by therapists. Trial registration ISRCTN 54744256 (http://www.isrctn.com/ISRCTN54744256).

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Section: Design Overviewmentioning

confidence: 99%

Section: Interventionsmentioning

confidence: 99%

Section: Interventionsmentioning

confidence: 99%

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The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial

Rombach

Dutton

2020

Rheumatology

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“…Several trials investigating the non-surgical management of BTOA have been recently completed or are under way, including the Osteoarthritis Thumb Therapy II (OTTER-2) trial and others involving splints [ 22 , 23 ]. The OTTER-2 trial is a pragmatic trial that used a placebo splint in order to address the methodological concern regarding an adequate comparator arm.…”

Section: Discussionmentioning

confidence: 99%

Base of thumb osteoarthritis in UK interface services—a cohort and survey-based study to assess current practice

et al. 2020

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Aim Base of thumb osteoarthritis (BTOA) is a common age-related disease which has a significant negative impact upon quality of life, while little is known about structure and pathways of interface services. Our aim was to assess disease burden, referral pathways, service structure and management pathways in UK interface services. Patients & Methods A structured questionnaire was carried out with a participating clinician at each centre to detail the local guidelines and management of BTOA. Five patients referred with BTOA were prospectively identified in each of 32 United Kingdom (UK) interface centres. Results Most centres (72%) had a local guideline and a standardised treatment regime consisting of education (100%), joint protection (100%), range of motion exercises (84%), strengthening exercises (88%), splintage (100%) and use of assistive devices (78%). No centre routinely offered a steroid injection at the first appointment and no centre had a specific threshold for offering an injection. Injection delivery was variable. Most patients had not been referred previously (82%). Most patients used analgesia (72%) but a minority of patients had been treated with a splint (46%), therapy (43%) and steroid injection (27%) prior to their latest attendance. Conclusion Most BTOA patients newly referred to interface services have been treated with analgesics and have not received comprehensive multimodal intervention. The management of BTOA at interface services is standardised in terms of education, splintage and therapy. However, there is a lack of standardisation in terms of both the threshold for, timing and mode of delivery of injection therapy.

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“…Given the importance of adherence to orthosis use in determining outcomes in research and clinical practice, there is a need to improve the quality and consistency of the measurement and reporting of this key outcome. This is particularly relevant to ongoing trials such as Osteoarthritis Thumb Therapy (OTTER) II (ISRCTN 54744256) where the clinical and costeffectiveness of a splint is being compared to a placebo splint and optimal self-management for the treatment of symptomatic thumb osteoarthritis [43]. A valid, robust, and reliable measure is therefore required that is acceptable to patients and can be used across all studies.…”

Section: Discussionmentioning

confidence: 99%

Methods for assessment of patient adherence to removable orthoses used after surgery or trauma to the appendicular skeleton: a systematic review

Davies

Yeomans

Tolkien

et al. 2020

Trials

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Background: Patient adherence to treatment is a key determinant of outcome for healthcare interventions. Whilst non-adherence has been well evidenced in settings such as drug therapy, information regarding patient adherence to orthoses, particularly in the acute setting, is lacking. The aim of this systematic review was to identify, summarise, and critically appraise reported methods for assessing adherence to removable orthoses in adults following acute injury or surgery. Methods: Comprehensive searches of the Ovid versions of MEDLINE, Embase, AMED, CINAHL, Central, the Cochrane Database of Systematic Reviews, and SPORTDiscus identified complete papers published in English between 1990 and September 2018 reporting measurement of adherence to orthoses in adults following surgery or trauma to the appendicular skeleton. Only primary studies with reference to adherence in the title/abstract were included to maintain the focus of the review. Data extraction included study design, sample size, study population, orthosis studied, and instructions for use. Details of methods for assessing adherence were extracted, including instrument/method used, frequency of completion, number of items (if applicable), and score (if any) used to evaluate adherence overall. Validity and reliability of identified methods were assessed together with any conclusions drawn between adherence and outcomes in the study. Results: Seventeen papers (5 randomised trials, 10 cohort studies, and 2 case series) were included covering upper (n = 13) and lower (n = 4) limb conditions. A variety of methods for assessing adherence were identified, including questionnaires (n = 10) with single (n = 3) or multiple items (n = 7), home diaries (n = 4), and discussions with the patient (n = 3). There was no consistency in the target behaviour assessed or in the timing or frequency of assessment or the scoring systems used. None of the measures was validated for use in the target population.

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The Osteoarthritis Thumb Therapy (OTTER) II Trial: a study protocol for a three-arm multi-centre randomised placebo controlled trial of the clinical effectiveness and efficacy and cost-effectiveness of splints for symptomatic thumb base osteoarthritis

Cited by 9 publications

References 48 publications

The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial

The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial

Base of thumb osteoarthritis in UK interface services—a cohort and survey-based study to assess current practice

Methods for assessment of patient adherence to removable orthoses used after surgery or trauma to the appendicular skeleton: a systematic review

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