ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

Other injuries and accidents

Physical Medicine / Rehabilitation

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]

Treatment: Drugs

Intervention code [2]

Treatment: Devices

Intervention code [3]

Rehabilitation

Comparator / control treatment

Hand therapy delivered in 3 sessions over 12 weeks.

Control group

Active

Outcomes

Primary outcome [1]

Change in Patient Rated Wrist and Hand Evaluation (PRWHE) Score

Timepoint [1]

Baseline, 6 weeks and 12 weeks after intervention commencement.

Secondary outcome [1]

Change in Global Rating of Change (GRC) score

Timepoint [1]

Baseline, 6 weeks and 12 weeks after intervention commencement

Secondary outcome [2]

Change in mean grip strength. Average of three trials assessed using a hydraulic grip strength gauge

Timepoint [2]

Baseline, 6 weeks and 12 weeks after intervention commencement

Secondary outcome [3]

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]

12 weeks and 6 months after intervention commencement.

Secondary outcome [4]

Wrist pain using a 100mm visual analogue scale.

Timepoint [4]

Baseline, 6 weeks and 12 weeks after intervention commencment

Secondary outcome [5]

Wrist range of motion using a manual goniometer

Timepoint [5]

Baseline, 6 weeks and 12 weeks

Secondary outcome [6]

Quality of life using the EQ-5D patient-reported questionnaire.

Timepoint [6]

Baseline, 6 weeks and 12 weeks.

Secondary outcome [7]

Change in abbreviated Disabilities of the Arm, Shoulder and Hand (QuickDASH) score

Timepoint [7]

Baseline, 6 weeks and 12 weeks

Secondary outcome [8]

Frequency of participants with re-injury to affected wrist. Assessed with a phone call to participants by a research assistant

Timepoint [8]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4000 - Brisbane

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Brisbane Hand & Upper Limb Research Institute

Address [1]

Level 9, Brisbane Private Hospital
259 Wickham Terrace, Spring Hill
Brisbane, Queensland 4000

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Queensland Hand Surgery Society

Address [2]

Griffith University and Gold Coast University Hospital
1 Hospital Boulevard, Southport, QLD 4215

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Health Human Research Ethics Committee

Ethics committee address [1]

Metro South Health HREC
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

21/06/2016

Ethics approval number [1]

HREC/16/QPAH/315

Summary

Brief summary

This study aims to determine the effectiveness and clinical outcomes of non-operative treatments offered to patients who have a triangular fibrocartilage complex (TFCC) injuries. 
Injury to the triangular fibrocartilage complex has been observed as a common cause of both short and long-term wrist pain, loss of wrist function and impact on quality of life. Currently, it is common practice for health care providers to initially recommend non-surgical or “conservative treatments” for patients. Treatments can include immobilising the wrist using a splint to relieve pain; injection of corticosteroid to reduce inflammation and provide pain relief; and hand therapy exercises to help manage pain and improve function. This study will investigate whether splint immobilisation, corticosteroid injection or a combination of the two, contribute to the efficacy of hand therapy, in relieving symptoms and improving function in patients with TFCC tears. Adults presenting with a MRI confirmed TFCC tear, between 6 weeks and 12 months from primary injury will be invited to participate in the research study.

Participants will be randomly allocated to one of four 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.

Participants will be asked to complete an electronic survey consisting questions specific to wrist pain and function. The survey will be completed in-person before treatment and at 6 weeks and 12 weeks after intervention commencement. The investigation will be conducted at the Brisbane Hand and Upper Limb Research Institute at the Brisbane Private Hospital.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Greg Couzens

Address

Level 9, Brisbane Private Hospital Specialist Centre
269 Wickham Terrace, Spring Hill
Brisbane,QLD 4000

Country

Australia

Phone

+61 (07) 3834 7069

Fax

researchmanager@upperlimb.com

Contact person for public queries

Name

Ruby Strauss

Address

Level 9, Brisbane Private Hospital Specialist Centre
269 Wickham Terrace, Spring Hill
Brisbane,QLD 4000

Country

Australia

Phone

+61 (07) 3834 7069

Fax

researchmanager@upperlimb.com

Contact person for scientific queries

Name

Ruby Strauss

Address

Level 9, Brisbane Private Hospital Specialist Centre
269 Wickham Terrace, Spring Hill
Brisbane,QLD 4000

Country

Australia

Phone

+61 (07) 3834 7069

Fax

researchmanager@upperlimb.com

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.	Type	Email	Attachment
1869	Study protocol	researchmanager@upperlimb.com	376283-(Uploaded-16-09-2020-09-42-05)-Study-related document.pdf
5331	Informed consent form	researchmanager@upperlimb.com
5332	Ethical approval	researchmanager@upperlimb.com

Results publications and other study-related documents

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