RecruitingACTRN12623000637640

Pilot and feasibility Randomised Controlled Trial (RCT) – Evaluation of Technology-Enhanced, Group-based (TEG) model of care following Carpal Tunnel Release (CTR) surgery.

Acceptability and feasibility of an innovative hand therapist-led, Technology-Enhanced, Group-based (TEG) model of care following Carpal Tunnel Release (CTR) surgery.


Sponsor

Surgical Treatment and Rehabilitation Service (STARS)

Enrollment

84 participants

Start Date

Oct 5, 2023

Study Type

Interventional

Conditions

Summary

This research study will evaluate the feasibility and preliminary efficacy of the TEG hand therapy model of care for people post CTR surgery within a public hospital-based (STARS), hand therapy service. It is expected that the outcomes of this study will determine the feasibility and acceptability of the new model of care and determine the feasibility of a future fully powered randomised controlled trial (RCT) that will determine the clinical and cost-effectiveness of the model of care. The TEG model aims to increase efficiency and outcomes, use telehealth delivery to improve patient access and app-based video-guided exercise and monitoring to improve self-management, adherence, and outcomes. Our hypotheses are that the TEG intervention will be acceptable and feasible for patients, and a future, larger randomised trial will be feasible to conduct. We will describe and explore the clinical and cost outcomes from this pilot RCT with due caution to not extrapolate results beyond the feasibility and pilot nature of the study.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Carpal tunnel syndrome (CTS) occurs when the median nerve running through the wrist is compressed, causing numbness, tingling, pain, and weakness in the hand. When symptoms are severe, surgery (carpal tunnel release) is recommended to relieve the pressure. After surgery, hand therapy helps restore movement, strength, and function — but standard face-to-face therapy appointments can be difficult to access. This pilot study tests a new model of care called TEG (Technology-Enhanced, Group-based) hand therapy, which combines telehealth video appointments with a smartphone app that guides home exercises and monitors progress. The study will explore whether this model is acceptable and practical for patients, and whether it could replace some traditional in-person visits. You may be eligible if you are 18 or older, have been diagnosed with carpal tunnel syndrome and listed for surgery at STARS (Surgical Treatment and Rehabilitation Service), and are able to read English. You will need a smartphone or tablet capable of running the app and supporting video calls. People who have had other concurrent hand surgery or have pre-existing complex hand conditions would not be eligible.

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Interventions

The research design is a single-centre, two-arm parallel group, independent assessor-blinded, pilot RCT. Participants will be randomised to receive either the TEG model of care (arm 1) or usual model

The research design is a single-centre, two-arm parallel group, independent assessor-blinded, pilot RCT. Participants will be randomised to receive either the TEG model of care (arm 1) or usual model of care (arm 2). Both models of care are led by the treating hand therapist. The TEG hand therapy model (arm 1) involves: 1. An initial appointment within 10-14 days post-CTR surgery in an in-person, group format comprising up to four patients for 30 minutes to one hour. During this appointment, sutures are removed for each patient and education is provided as a group regarding carpal tunnel surgery, post-operation recovery and the hand therapy program involved. During suture removal, infection control measures will include the use of separate tables, social distancing, separate wound care packs, aseptic non-touch technique (ANTT) and handwashing between each patient. Range of motion (active tendon gliding, thumb and wrist) exercises and median nerve sliding exercises are prescribed as a group three times a day to encourage early movement after surgery and reduce scar adherence. Scar management including scar massage with non-slip matting 3 times a day, and silicone sheeting worn at night is commenced as a group. 2. A home therapy program is prescribed using the mobile telephone /computer-based app, PhysiTrack App, and will comprise of interactive videos, reminders and prompts to increase self-monitoring to the home program. The home program will include the exercises that were prescribed in the initial appointment (eg. range of motion exercises 3 times a day, scar massage 3 times a day), and the patient will be instructed to complete this program for 12 weeks post-operation. The patient will be assisted in the set-up of the app and a demonstration of how to use the app will be provided. A written log designed to prompt completion of the home program each day is provided at the first appointment (and will also be used to monitor adherence to the home program, in addition to the app). 3. A review appointment is scheduled at six weeks post-operation in a one-to-one format via a telehealth or telephone (depending on patients’ preference) 30-minute appointment. Progress is reviewed regarding pain, oedema, scar healing, range of motion and functional use. Strengthening is commenced using theraputty exercises 2 times a day.


Locations(1)

Surgical Treatment and Rehabilitation Service (STARS) - Herston

QLD, Australia

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ACTRN12623000637640


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