Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000886189
Ethics application status
Approved
Date submitted
11/06/2019
Date registered
24/06/2019
Date last updated
11/03/2021
Date data sharing statement initially provided
24/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-operative management of TFCC injury; a randomised, control trial investigating hand therapy, wrist splint and cortisone injection for triangular fibrocartilage complex injuries in the wrist
Scientific title
The impact of hand therapy, volar wrist splinting and corticosteroid injection, on pain and function outcomes of triangular fibrocartilage complex injuries in adults
Secondary ID [1] 296460 0
Nil known
Universal Trial Number (UTN)
U1111-1235-1322
Trial acronym
TFCC RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Triangular fibrocartilage complex injury 310250 0
Condition category
Condition code
Musculoskeletal 308973 308973 0 0
Other muscular and skeletal disorders
Injuries and Accidents 308974 308974 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 308975 308975 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of four treatment groups:
Group A: will receive hand therapy
Group B: will receive a thermoplastic, volar wrist splint + hand therapy
Group C: will receive a corticosteroid injection to the wrist + hand therapy
Group D: will receive a wrist splint + corticosteroid injection + hand therapy

All procedures and appointments will be based in Brisbane, Queensland.

Hand therapy (all participants)
Participants will have a 30 minute therapy session with a qualified hand therapist at baseline and two 15 minute sessions, at 2 and 6 weeks post baseline. The hand therapist will use a therapy protocol designed by study investigators to deliver advice on protecting the wrist using activity modification and instruct the participant on an exercise regime to follow at home. All participants, irrespective of treatment randomisation, will be provided with the same Hand Therapy Protocol booklet to follow at home. Participants will be encouraged to use the support of their unaffected wrist when performing activities that may otherwise aggravate symptoms of the injured wrist.
The protocol is divided into three phases, to be provided to participants in installments at each therapy appointment. A 2kg and 0.5kg vinyl dumbbell will be provided to participants at the baseline and 2 week appointment for the completion of exercises at home. Phase one, delivered at baseline, involves daily active range of motion exercises and bicep curls using a 2kg weight. Phase two, initiated at 2 weeks post baseline, incorporates the addition of resistance exercises. All prescribed exercises from the first phase will continue, with the addition of an isometric ECU exercise and resisted pronation with a 0.5kg dumbbell. Phase three, commencing 6 weeks post baseline, includes further strengthening exercises and gentle loading to the wrist. The 0.5kg weight will be used to perform resisted ulnar deviation and controlled wall push-ups will be included in the home exercise regime from 6 weeks, in addition to the exercises prescribed in the first two phases. Compliance to the exercise regime over the 12-week treatment period will be recorded on a patient-reported exercise log provided to all participants.

Thermoplastic, volar wrist splint (Treatment arms B and D)
At the baseline therapy appointment, the therapist will fit a custom thermoplastic, volar wrist splint. As two therapy clinics will be administering treatment, a standardised design protocol designed by study investigators will be distributed to ensure consistency between therapists and clinics. The splint design will be a short-arm, volar thermoplastic splint. The splint will be approximately two thirds of the length of the patients forearm and cover half of the circumference on the volar/palmer side of the wrist. Care will be taken to ensure that the ulnar styloid is not covered, the thumb is free to allow full opposition and that range of movement of the MCP joints are not restricted. Velcro straps will be used to secure the splint and a tubigrip sleeve will be worn underneath for comfort. Participants will be instructed to wear the splint during the day for 6 weeks, before reducing to symptomatic use only for 2 weeks.

Corticosteroid injection (Treatment arms C and D)
On the day of the 6 week treatment appointment following hand therapy the participant will be referred to a radiologist who will administer a corticosteroid injection to the wrist. A 1 mL betamethasone sodium phosphate/betamethasone acetate injection with 0.5% bupivacaine hydrochloride will be injected under direct ultrasound guidance to the triangular fibrocartilage complex of the wrist.

Symptomatic and functional progress in addition to compliance to treatment protocols will be monitored using patient-reported questionnaires administered in-person at baseline, 6 weeks and 12 weeks. The questionnaire will be administered by a research assistant at individual participant appointments.
Intervention code [1] 312793 0
Treatment: Drugs
Intervention code [2] 312794 0
Treatment: Devices
Intervention code [3] 312795 0
Rehabilitation
Comparator / control treatment
Hand therapy delivered in 3 sessions over 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 307946 0
Change in Patient Rated Wrist and Hand Evaluation (PRWHE) Score
Timepoint [1] 307946 0
Baseline, 6 weeks and 12 weeks after intervention commencement.
Secondary outcome [1] 353433 0
Change in Global Rating of Change (GRC) score
Timepoint [1] 353433 0
Baseline, 6 weeks and 12 weeks after intervention commencement
Secondary outcome [2] 353434 0
Change in mean grip strength. Average of three trials assessed using a hydraulic grip strength gauge
Timepoint [2] 353434 0
Baseline, 6 weeks and 12 weeks after intervention commencement
Secondary outcome [3] 353435 0
Failure of conservative management, as deemed by the treating orthopaedic specialist, necessitating further treatment to the affected wrist. Additional treatment received will be confirmed by participants via a phone call from a research assistant.
Timepoint [3] 353435 0
12 weeks and 6 months after intervention commencement.
Secondary outcome [4] 353436 0
Wrist pain using a 100mm visual analogue scale.
Timepoint [4] 353436 0
Baseline, 6 weeks and 12 weeks after intervention commencment
Secondary outcome [5] 353438 0
Wrist range of motion using a manual goniometer
Timepoint [5] 353438 0
Baseline, 6 weeks and 12 weeks
Secondary outcome [6] 353439 0
Quality of life using the EQ-5D patient-reported questionnaire.
Timepoint [6] 353439 0
Baseline, 6 weeks and 12 weeks.
Secondary outcome [7] 369426 0
Change in abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH) score
Timepoint [7] 369426 0
Baseline, 6 weeks and 12 weeks
Secondary outcome [8] 371609 0
Frequency of participants with re-injury to affected wrist. Assessed with a phone call to participants by a research assistant
Timepoint [8] 371609 0
6 and 12 months after intervention commencement.

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion in the study if they are:
1. Have a clinical diagnosis of TFCC localised, ulnar-sided wrist pain
2. Are between 6 weeks and 12 months from initial injury;
3. MRI confirmation of isolated TFCC tear;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they present with:
1. Frank instability of the distal radioulnar joint (DRUJ);
2. Arthritis of the distal radioulnar joint (DRUJ);
3. Concomitant injury (e.g. scaphoid fracture) in addition to TFCC tear;
4. Prior splint use or injection in the last 3 months to the affected wrist
5. Pregnancy due to risks associated with the corticosteroid injections;
6. Known allergies or adverse reactions to hydrocortisone and local anaesthetic (HCLA) injections;
7. Medical dependency that may interfere with ability to complete assessments or compliance;

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)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/06/2019
Actual
30/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 24500 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 301057 0
Other Collaborative groups
Name [1] 301057 0
Brisbane Hand & Upper Limb Research Institute
Country [1] 301057 0
Australia
Funding source category [2] 301064 0
Charities/Societies/Foundations
Name [2] 301064 0
Queensland Hand Surgery Society
Country [2] 301064 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Brisbane Hand & Upper Limb Research Institute
Address
Level 9, Brisbane Private Hospital
259 Wickham Terrace, Spring Hill
Brisbane, Queensland 4000
Country
Australia
Secondary sponsor category [1] 300664 0
None
Name [1] 300664 0
Address [1] 300664 0
Country [1] 300664 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301811 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 301811 0
Ethics committee country [1] 301811 0
Australia
Date submitted for ethics approval [1] 301811 0
Approval date [1] 301811 0
21/06/2016
Ethics approval number [1] 301811 0
HREC/16/QPAH/315

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88190 0
Dr Greg Couzens
Address 88190 0
Level 9, Brisbane Private Hospital Specialist Centre
269 Wickham Terrace, Spring Hill
Brisbane,QLD 4000
Country 88190 0
Australia
Phone 88190 0
+61 (07) 3834 7069
Fax 88190 0
Email 88190 0
[email protected]
Contact person for public queries
Name 88191 0
Ruby Strauss
Address 88191 0
Level 9, Brisbane Private Hospital Specialist Centre
269 Wickham Terrace, Spring Hill
Brisbane,QLD 4000
Country 88191 0
Australia
Phone 88191 0
+61 (07) 3834 7069
Fax 88191 0
Email 88191 0
[email protected]
Contact person for scientific queries
Name 88192 0
Ruby Strauss
Address 88192 0
Level 9, Brisbane Private Hospital Specialist Centre
269 Wickham Terrace, Spring Hill
Brisbane,QLD 4000
Country 88192 0
Australia
Phone 88192 0
+61 (07) 3834 7069
Fax 88192 0
Email 88192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data from participants who have given permission to share their data for research projects.
Names will be removed, dates of birth will be converted to ages and individual identifiers will be removed rendering the data non-identifiable
When will data be available (start and end dates)?
The start date of IPD availability will be 1/12/2024 with no end-date.
Available to whom?
Available to researchers with Ethics-approved projects (must provide protocol and evidence of approval).
Available for what types of analyses?
Available for analysis for any research with Ethics approval.
How or where can data be obtained?
We intend to share the data in med.data.edu.au.
Licencing will be discussed with med.data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1869Study protocol  [email protected] 376283-(Uploaded-16-09-2020-09-42-05)-Study-related document.pdf
5331Informed consent form  [email protected]
5332Ethical approval  [email protected]



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.