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Relative Motion Extension - Orthosis use in treating Trigger finger (ReMEx-OT) in the adult population – A multi-centre, randomised, superiority trial

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18264301
Enrollment
100
Registered
2024-11-14
Start date
2025-02-28
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improvement of self-reported wrist/hand pain and functioning outcomes in patients with trigger finger Musculoskeletal Diseases

Interventions

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 occupa

Sponsors

Our Lady’s Hospital, Navan
Lead Sponsor
Health Service Executive
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Patient-Rated Wrist and Hand Evaluation (PRWHE), measured at 3, 6, 9, 12 and 15 weeks after randomisation, expressed as the mean total score Updated 12/03/2026 to change final timepoint from 16 weeks to 15 weeks

Secondary

MeasureTime frame
1. Grip strength measured using a handheld dynamometer according to standard protocols at 3 and 6 weeks post randomisation 2. Trigger severity objectively assessed using the Stages of Stenosing Tenosynovitis (at 3 and 6 weeks post randomisation) and subjectively via a patient-reported severity scale (at 3, 6, 9, 12 and 15 weeks post randomisation) 3. Trigger frequency measured by the number of trigger events during ten active fists (at 3 and 6 weeks post randomisation) and reported by participants (at 3, 6, 9, 12 and 15 weeks post randomisation) 4. Orthosis wear time documented by patients in a daily diary, recorded on a 10 cm scale representing 10% increments for the entire duration of orthotic use (6 weeks) 5. Orthosis satisfaction assessed on a 0-10 scale, with 0 representing "strongly disagree" and 10 representing "strongly agree" with satisfaction-related statements (at 3 and 6 weeks) Updated 12/03/2026 to change final timepoint from 16 weeks to 15 weeks

Countries

Ireland

Contacts

Public ContactManigandan Chockalingam
Manigandan.Chockalingam@universityofgalway.ie+353 (91) 495313

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026