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Trial registered on ANZCTR


Registration number
ACTRN12623000637640
Ethics application status
Approved
Date submitted
31/05/2023
Date registered
13/06/2023
Date last updated
19/11/2023
Date data sharing statement initially provided
13/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot and feasibility Randomised Controlled Trial (RCT) – Evaluation of Technology-Enhanced, Group-based (TEG) model of care following Carpal Tunnel Release (CTR) surgery.
Scientific title
Acceptability and feasibility of an innovative hand therapist-led, Technology-Enhanced, Group-based (TEG) model of care following Carpal Tunnel Release (CTR) surgery.
Secondary ID [1] 309796 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
TEG (Technology-Enhanced, Group-based) model of care
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Carpal Tunnel Surgery 330205 0
Condition category
Condition code
Physical Medicine / Rehabilitation 327075 327075 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326225 0
Rehabilitation
Comparator / control treatment
The usual care hand therapy model (arm 2) involves:
1. An initial appointment within 10-14 days post-operation in an in-person, one-to-one format for 30 minutes. During this appointment sutures are removed, and education is provided regarding carpal tunnel surgery, post-operation recovery and the hand therapy program involved. During suture removal, infection control measures will include the use of a wound care pack, aseptic non-touch technique (ANTT) and handwashing by the hand therapist. Additionally, range of motion (active tendon gliding, thumb and wrist) exercises and median nerve sliding exercises are prescribed three times a day to encourage early movement after surgery. Scar management including scar massage with non-slip matting 3 times a day, and silicone sheeting worn at night is commenced to reduce scar adherence and assist scar maturation.
2. A written home therapy program is prescribed, including provision of education, exercise and scar management patient handouts with text and photographic descriptions. 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. 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).
3. A review appointment is scheduled at six weeks post-CTR surgery in an in-person, one-to-one format for 30 minutes. During this appointment, review of progress occurs regarding pain, oedema, scar healing, range of motion and functional use. Strengthening is commenced using theraputty exercises 2 times a day.
The usual care hand therapy model (arm 2) involves in-person, one-on-one appointments at 10-14 days post-CTR surgery (initial) and 6-week post-operation (review), with a paper-based home therapy program. Participant adherence to the home therapy program will be assessed using a patient-completed home therapy program written log for arm 2.
Control group
Active

Outcomes
Primary outcome [1] 334938 0
Degree of Acceptability - of the TEG model of care and usual care model will be examined using the Acceptability of Intervention Measure (AIM), a 4 item, 5-point Likert scale, designed to measure acceptability of interventions.
Timepoint [1] 334938 0
At follow-up - within 1 week following 6-week post-CTR surgery hand therapy review appointment
Primary outcome [2] 334939 0
Degree of Feasibility - to establish feasibility of recruitment and reasons for ineligibility, a screening log will be completed. This will include, for each person screened: name and UR number, invited and screened, the date invited, whether eligible or not, reason for ineligibility (if applicable), whether consent to participate was provided or not. This data is needed to enable the number of participants screened, approached, eligible (and reason for exclusion), and randomised to be determined (SEAR data). To establish feasibility of both hand therapy models a log will be completed. This will include the number of intervention sessions (group, one-to-one), number of participants in each group, number of ‘did not attend’ appointments, length of time spent at each appointment, resource needs and administrative time, follow-up rates and data completeness. Feasibility of the TEG model of care will be examined by recording number choosing phone/videoconferencing. All logs will be stored electronically in a dedicated Research Folder within secure QLD Health electronic systems accessible only by members of the research team. The Feasibility of Intervention Measure (FIM), a 4 item, 5-point Likert scale, designed to measure feasibility of interventions, will also be administered.
Timepoint [2] 334939 0
Feasibility of recruitment and reasons for ineligibility, including SEAR data will be collected by the orthopaedic case manager as participant recruitment occurs. Data collected regarding the feasibility of both hand therapy models will be collected by the treating hand therapist as patient treatment occurs. The FIM will be administered at follow-up, within 1 week following 6-week post-CTR surgery hand therapy review appointment.
Primary outcome [3] 334941 0
Degree of Satisfaction - The Patient Satisfaction Questionnaire Short Form (PSQ-18) is an 18-question patient satisfaction survey, divided into 7 subscales. Each item is rated on a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The general satisfaction subscale (2 questions) and the time spent with hand therapist subscale (2 questions) will also be administered. The following closed and open-ended questions will be included to further explore participants perceptions about aspects of their intervention (either the TEG or usual care) as well as determine other healthcare use related to Carpal Tunnel Syndrome (CTS) during the trial period:
1. Did you attend other health care appointments (in addition to STARS hand therapy appointments) since your CTR surgery? (yes/no). If yes, please describe the type of appointments (eg. Physiotherapy) and how many appointments (eg. Each week for 1 hour)
2. Did you like receiving your first therapy appointment in a group / on a one-to-one basis? (Yes/No). Describe what you liked/didn’t like about the group-format/one-to-one format (eg. Would you change anything)
3. Did you like using the mobile phone app / written paper handouts to follow your hand therapy program? (Yes/No). Describe what you liked/didn’t like about the mobile phone app/written paper handouts (eg. Would you change anything)
4. Did you like having your follow up appointment via tele-rehabilitation (telehealth or phone) / face-to-face? (Yes/No). Describe what you liked/didn’t like about tele-health or phone/face-to-face
5. Are there any other comments you would like to make about the hand therapy you received at STARS after your recent CTR surgery?
Timepoint [3] 334941 0
At follow-up - within 1 week following 6-week post-CTR surgery hand therapy review appointment
Secondary outcome [1] 422491 0
Degree of Pain - measured using the 10mm Numerical Rating Scale (NRS), a validated commonly used patient-reported outcome measure (PROM) for patient with CTS. It is used to assess pain severity at a moment in time using a 0 to 10 scale, with zero meaning ‘no pain’ and 10 meaning ‘the worst pain imaginable’.
Timepoint [1] 422491 0
At baseline - following CTR surgery and prior to initial hand therapy appointment at 10-14 days post-operation, and at follow-up - within 1 week following 6-week post-CTR surgery hand therapy review appointment
Secondary outcome [2] 422492 0
Health-related Quality of Life index value - measured using the EQ-5D-5L, a generic measure of health-related quality of life that produces a single index value for health status that can be used for the purpose of clinical and health economic evaluation. The EQ-5D-5L consists of questions relating to five health domains (mobility, self-care, usual activities pain/discomfort, anxiety/depression) and respondents’ self-rate their degree of impairment using five response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).
Timepoint [2] 422492 0
At baseline - following CTR surgery and prior to initial hand therapy appointment at 10-14 days post-operation, and at follow-up - within 1 week following 6-week post-CTR surgery hand therapy review appointment.
Secondary outcome [3] 422493 0
Upper limb function measure - measured using the Boston Carpal Tunnel Questionnaire (BCTQ), the most used validated Patient-Reported Outcome Measure (PROM) for patients with CTS. It is an 11-item questionnaire, using a 5-point Likert scale, to measure symptom severity and functional status. When the items are summed and averaged, this produces an overall score with 1 being the best outcome.
Timepoint [3] 422493 0
At baseline - following CTR surgery and prior to initial hand therapy appointment at 10-14 days post-operation, and at follow-up - within 1 week following 6-week post-CTR surgery hand therapy review appointment.
Secondary outcome [4] 422704 0
Upper limb function measure - also measured using the Patient Specific Functional Scale (PSFS). It is a PROM used to quantify activity limitation and measure functional outcome for CTS. It is valid, reliable, responsive, and acceptable to patients. Patients are asked to identify up to 5 activities they are having difficulty with due to their condition and asked to rate the current level of difficulty on an 11-point scale, with 0 representing unable to perform the activity and 10 representing able to perform the activity at the same level as before the injury or problem. The total score is the sum of the activity scores divided by the number of activities listed, with the minimum detectable change for the average score for CTS being 2 points.
Timepoint [4] 422704 0
At baseline - following CTR surgery and prior to initial hand therapy appointment at 10-14 days post-operation, and at follow-up - within 1 week following 6-week post-CTR surgery hand therapy review appointment.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment via use of sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule of permuted block sizes of 2 and 4 will assign patients in a 1:1 ratio to groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation - considering an average of 20 CTR surgeries per month are undertaken at STARS it is estimated that 14 participants (approx. 70%) could be recruited each month (allowing for those who are potentially ineligible, decline to participate, cancel their surgery or appointments, and variations in surgical list sizes). With a 6-month recruitment window, it is anticipated that 84 participants could be recruited but this is part of the feasibility assessment of this study. For the TEG approach the smallest number per therapy group will be one, so that all participants eligible and wanting to participate can be accommodated during randomisation. This considers variations in surgical list sizes, and the need for sufficient CTR surgeries in close time-blocks to be able to provide the 10–14-day post CTR surgery appointment in a group. Participants that provide consent to be involved in the study will not be randomised until after their CTR surgery. A sample size of 84 (42 per arm) is sufficient to assess acceptability and feasibility.

Statistical methods and analysis - the comparison of interest is between the TEG model of care and usual care. Categorical variables will be summarised by frequency and percent and continuous variables by mean and standard deviation (SD) or median and interquartile range (IQR). Categorical variables will be examined using Pearson’s Chi-squared test or Fisher’s exact test and continuous variables by a student t-test or Mann-Whitney U test. A two-sided p-value < 0.05 will be considered significant. Incremental cost-effectiveness ratio will be estimated, which is the difference in costs divided by the difference in effects between TEG and usual care. Uncertainty around the ICER will be estimated using bootstrapping, the value of information analysis will be conducted to inform the value and efficient design of a larger study.

The study statistician will receive anonymised exported data sets for data checking and analysis. The chief investigator and study statistician have responsibility to ensure the integrity of the data and that all confidentiality procedures are followed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
5/10/2023
Date of last participant enrolment
Anticipated
23/02/2024
Actual
Date of last data collection
Anticipated
5/04/2024
Actual
Sample size
Target
84
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24818 0
Surgical Treatment and Rehabilitation Service (STARS) - Herston
Recruitment postcode(s) [1] 40467 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 313977 0
Hospital
Name [1] 313977 0
Metro North Hospital and Health Service Health Practitioner Research Scheme, Surgical Treatment and Rehabilitation Service (STARS)
Country [1] 313977 0
Australia
Primary sponsor type
Hospital
Name
Surgical Treatment and Rehabilitation Service (STARS)
Address
296 Herston Road
Herston, Queensland, 4029.
Country
Australia
Secondary sponsor category [1] 315851 0
University
Name [1] 315851 0
University of Queensland
Address [1] 315851 0
Sir Fred Schonell Drive
St Lucia, Queensland, 4067.
Country [1] 315851 0
Australia
Secondary sponsor category [2] 315859 0
Government body
Name [2] 315859 0
QIMR Berghofer Medical Research Institute
Address [2] 315859 0
300 Herston Road
Herston, Queensland, 4006.
Country [2] 315859 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313115 0
Metro North Health Human Research Ethics Committee
Ethics committee address [1] 313115 0
Metro North Hospital and Health Service
Block 7, Level 7
Butterfield Street,
Herston QLD 4029
Ethics committee country [1] 313115 0
Australia
Date submitted for ethics approval [1] 313115 0
03/05/2023
Approval date [1] 313115 0
15/06/2023
Ethics approval number [1] 313115 0

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127046 0
Mrs Emma Taylor
Address 127046 0
Surgical Treatment and Rehabilitation Service (STARS)
296 Herston Rd
Herston 4029, Qld.
Country 127046 0
Australia
Phone 127046 0
+61 7 3647 6324
Fax 127046 0
Email 127046 0
emma.taylor@health.qld.gov.au
Contact person for public queries
Name 127047 0
Mrs Emma Taylor
Address 127047 0
Surgical Treatment and Rehabilitation Service (STARS)
296 Herston Rd
Herston 4029, Qld.
Country 127047 0
Australia
Phone 127047 0
+61 7 3647 6324
Fax 127047 0
Email 127047 0
emma.taylor@health.qld.gov.au
Contact person for scientific queries
Name 127048 0
Dr Emmah Doig
Address 127048 0
Surgical Treatment and Rehabilitation Service (STARS)
296 Herston Rd
Herston 4029, Qld
Country 127048 0
Australia
Phone 127048 0
+61 0432 901 340
Fax 127048 0
Email 127048 0
emmah.doig@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19315Study protocol    385997-(Uploaded-31-05-2023-13-29-35)-Study-related document.docx
19316Informed consent form    385997-(Uploaded-31-05-2023-13-29-58)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.