Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000937718
Ethics application status
Approved
Date submitted
28/06/2022
Date registered
1/07/2022
Date last updated
1/07/2022
Date data sharing statement initially provided
1/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Redesigning care post carpal tunnel release: A comparison of standard care with self-directed hand therapy intervention
Scientific title
Does targeted rather than routine referral to hand therapy following carpal tunnel release allow for better allocation of hand therapy resources with non-inferior patient outcomes: A randomised controlled trial
Secondary ID [1] 307447 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carpal Tunnel Release 326822 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324038 324038 0 0
Occupational therapy
Surgery 324056 324056 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group – Multi-modal hand therapy management package post Carpal Tunnel Release
The participant is provided with a self-directed hand therapy management package which consists of a paper handout. The handout demonstrates digit range of motion exercises, scar management, activity precautions and expectations post-surgery. Guidance is provided around monitoring for wound infections and where/when to seek help.
The handout is supported by a QR code linking the participant to a 5 minute video guiding their post-operative therapy.
Participants will have the opportunity to call and book a hand therapy appointment via Telehealth, telephone or in person as per the standard care pathway if they are concerned with their progress.
The handout and video have been created specifically for this study.
Intervention code [1] 323898 0
Treatment: Other
Comparator / control treatment
Standard Care post Carpal Tunnel Release
A hand therapist will provide digit and wrist range of motion exercises. Scar management and activity precautions will be discussed. A handout designed specifically for the study is provided to the participant at the time of appointment.
The standard care is often a one-off 30 minute appointment which is conducted in person, via Telehealth or telephone.
However, pending the participants progress after surgery the therapist will utilise their clinical reasoning to determine if further therapy is required. When the participant is progressing well, and the therapist has no further clinical concerns they will be discharged from the hand therapy service.
Control group
Active

Outcomes
Primary outcome [1] 331828 0
Hand function and carpal tunnel symptoms: The Boston Carpal Tunnel Questionnaire
Timepoint [1] 331828 0
Measured at 1-3 weeks and 3 months (primary endpoint) post-surgery
Primary outcome [2] 331829 0
Participant satisfaction: ICHOM Satisfaction with Treatment Results Questionnaire
Timepoint [2] 331829 0
Measured at 3 months post surgery
Secondary outcome [1] 411317 0
Complications: measured using the ICHOM Complications questionnaire. Possible complications include: heightened pain/complex regional pain syndrome, poor digit range of motion that was not pre-existing, participant not responding to therapy, ongoing neuropathic symptoms.
Timepoint [1] 411317 0
Recorded as required during the study period (0-3 months post-operatively)
Secondary outcome [2] 411325 0
Numeric pain rating scale
Timepoint [2] 411325 0
Measured at 1-3 weeks and 3 months post-surgery
Secondary outcome [3] 411326 0
Number of hand therapy sessions: measured using patient medical records
Timepoint [3] 411326 0
Measured at the time of therapy discharge.
Secondary outcome [4] 411327 0
Time frame for return to work: measured using ICHOM Return to Work Questionnaire
Timepoint [4] 411327 0
Measured at 3 months post-surgery

Eligibility
Key inclusion criteria
Open Carpal Tunnel Release (OCTR) surgery, for management of chronic non-traumatic Carpal Tunnel Syndrome (CTS)
Adult (aged 18 year or over)
English language proficiency sufficient to provide informed consent and complete outcome measures, or able to be assisted with understanding by interpreter
Surgery completed by Austin Health Plastic Surgery team
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Repeat OCTR surgery on the same limb
Other surgical procedures completed in conjunction with OCTR
OCTR as management for an acute traumatic injury (eg. crush hand, hand and wrist fractures, compartment syndrome)
Cognitive impairment

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence generation using Sealed Envelope Limited statistical software (Sealed Envelope Ltd., 2017) created for each participating centre using random block sizes of 2, 4, and 6.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/07/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22644 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 37919 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 311716 0
Charities/Societies/Foundations
Name [1] 311716 0
Australian Hand Therapy Association (AHTA)
Country [1] 311716 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Occupational Therapy Department
Studley Road
Heidelberg, VIC 3084
Country
Australia
Secondary sponsor category [1] 313176 0
None
Name [1] 313176 0
Address [1] 313176 0
Country [1] 313176 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311167 0
Austin Health Human Research Ethics Research Committee
Ethics committee address [1] 311167 0
145 Studley Road
Heidelberg, VIC 3084
Ethics committee country [1] 311167 0
Australia
Date submitted for ethics approval [1] 311167 0
27/05/2022
Approval date [1] 311167 0
07/06/2022
Ethics approval number [1] 311167 0
HREC/82435/Austin-2022

Summary
Brief summary
This randomised control trial aims to evaluate outcomes following a) standard care, and b) a multimodal hand therapy management package to deliver acute post-operative hand therapy education and care, guide patient expectations of key milestones in recovery, and highlight ‘triggers’ to help patients identify when and how to access the hospital hand therapy service. We hypothesise targeted, rather than routine referral to HT may allow better allocation of resources with non-inferior patient outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120186 0
Ms Hana Peake
Address 120186 0
Occupational Therapy Department
Austin Health - Repatriation Campus
190 Banksia Street
Heidelberg West, VIC 3081
Country 120186 0
Australia
Phone 120186 0
+61 03 94962197
Fax 120186 0
Email 120186 0
hana.peake@austin.org.au
Contact person for public queries
Name 120187 0
Ms Hana Peake
Address 120187 0
Occupational Therapy Department
Austin Health - Repatriation Campus
190 Banksia Street
Heidelberg West, VIC 3081
Country 120187 0
Australia
Phone 120187 0
+61 03 94962197
Fax 120187 0
Email 120187 0
hana.peake@austin.org.au
Contact person for scientific queries
Name 120188 0
Ms Hana Peake
Address 120188 0
Occupational Therapy Department
Austin Health - Repatriation Campus
190 Banksia Street
Heidelberg West, VIC 3081
Country 120188 0
Australia
Phone 120188 0
+61 03 94962197
Fax 120188 0
Email 120188 0
hana.peake@austin.org.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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.