None listed
Conditions
Brief 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.
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 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, s
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.
Sponsors
Surgical Treatment and Rehabilitation Service (STARS)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Patients with a clinical diagnosis of CTS (by treating surgeon) and listed for CTR surgery at STARS 2) Aged 18 years of age or older 3) Able to understand English
Exclusion criteria
1) Patients who are not able to and not planning on returning to STARS for face to face in-person initial and review post-operative outpatient hand therapy appointments 2) Patients who do not have access to a smart mobile phone or tablet computer capable of hosting the app-based home therapy program and supporting telehealth video communications 3) Patients listed for CTR and concurrent hand surgical procedures (eg. Trigger finger release) 4) Atypical CTS that is likely to require an alternative (ie. more intensive) intervention such as a person with a concurrent condition (e.g. pre-existing chronic hand pain syndrome, trauma-related symptoms ie. hand/wrist fracture, or systemic inflammatory condition) 5) Prior hand / wrist surgery on the affected side within the last 6 months 6) Patients who are unable to provide full informed consent
Outcome results
None listed