A multi-centre, investigator-blinded, randomised, 6-week, parallel-group, superiority trial to compare the efficacy of using the Metacarpophalangeal Joint Blocking Orthosis (MCPJ-BO) versus the Relative Motion Extension - Orthosis (RME-O) in reducing pain and improving function of trigger finger in the adult population
Improvement of self-reported wrist/hand pain and functioning outcomes in patients with trigger finger
Participants will be randomly assigned to one of two intervention groups, relative motion extension orthosis (RME-O) or metacarpophalangeal joint blocking orthosis (MCPJ-BO), during their first occupational therapy appointment. An independent researcher will conduct baseline assessments. A trained hand therapist will fabricate the assigned orthosis per standardised protocols. The MCPJ-BO restricts flexion at the metacarpophalangeal joint to prevent the triggering of the A1 pulley. The RME-O positions the affected digit in relative extension, potentially enhancing palmar sensitivity and functional hand use. Both orthoses will be prescribed for full-time use over six weeks, with patients documenting adherence in a diary. Removal will only be permitted for hygiene purposes. All participants will receive standardised educational materials and exercise instructions. A 1:1 randomisation system will be used to allocate participants to either the MCPJ-BO or RME-O intervention arms after eligibility has been confirmed, consent has been obtained, and all baseline data have been collected. The computer-generated allocation schedule will be included in concealed, opaque, consecutively numbered envelopes by someone not otherwise involved in the study. Due to the nature of the intervention, it is not possible to blind patients and their treating therapist to the allocation of treatment. The outcome assessor, however, will be blinded to the participant's allocation to avoid bias in the collection of primary and secondary outcomes.
1. Adults aged 18 years and over with TF diagnosed by a hand therapist, general practitioner, orthopaedic, or rheumatology doctor, presenting with a grade between 2 and 5 SST of the index, middle, ring, or little finger 2. Able to communicate adequately in English and give informed consent 3. As TF is commonly observed among patients with musculoskeletal disorders and other associated diagnoses such as arthritis, diabetes and carpal tunnel syndrome, these will be included
1. Those who have previously failed with orthotic intervention, received corticosteroid injections or surgical release of A1 pulley for the symptomatic digit 2. Multiple-digit TF 3. Triggering of the thumb 4. Patients who are pregnant 5. Those patients who are unable to consent or adhere with the intervention for various reasons, such as cognitive, psychological, or physical impairments