Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001100684
Ethics application status
Approved
Date submitted
14/09/2023
Date registered
20/10/2023
Date last updated
20/10/2023
Date data sharing statement initially provided
20/10/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relative motion flexion orthosis compared to dorsal blocking orthosis for zone 1-2 flexor tendon rehabilitation in adults – a feasibility and pilot study for a randomised control trial.
Scientific title
Relative motion flexion orthosis compared to dorsal blocking orthosis for zone 1-2 flexor tendon rehabilitation in adults – a feasibility and pilot study for a randomised control trial.
Secondary ID [1] 310207 0
Nil Known
Universal Trial Number (UTN)
U1111-1295-8451
Trial acronym
ReFlex Splint Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Flexor tendon repair in zones 1 and 2 in the hand 330888 0
Condition category
Condition code
Musculoskeletal 327678 327678 0 0
Other muscular and skeletal disorders
Injuries and Accidents 327679 327679 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 327680 327680 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the study will be randomly allocated to either a relative motion flexion orthosis (RMFO) group or a dorsal blocking orthosis control group.
Participants will be administered an orthosis within 3-7 days of tendon repair surgery.
The RMFO group will wear the wrist and yoke components of the splint for 3 weeks full time. Participants will perform daily exercises whilst in their splints
The dorsal wrist component will be weaned daily at 3-5 weeks for light activities and exercises only, the RMO component will continue to be worn full time. Weaning of the splint is not time limited but is limited to activities which are light in loading the flexor tendons. This information and a list of suitable light activities are listed in the handout provided called 'hand tendon repair advice handout'.
The dorsal wrist component will be completely weaned at 5-7 weeks. Participants will then be asked to wean the RMO after 7 weeks and commence strengthening and return to usual activities of daily living.
Participants in both groups will be advised to avoid heavy lifting and contact sports until 12 week after tendon repair

The RMFO group will receive weekly wound care, scar management, education and exercises as part of standard care from their physiotherapist.
Wound care will be removal of handy gauze cohesive dressing, skin cleaning with saline solution and reapplication of handy gauze dressing, scar management will be education as per the 'looking after your scar' handout and further education and exercises as per the tendon repair advice and flexor tendon repair early active movement handouts

A Physiotherapist working in Hand Therapy will provide education to the participant which will personalised to participants based on their specific injury.
Education will include flexor tendon early active movement rehabilitation, involved structures, healing times, warnings, risks and precautions.

Handouts provided and discussed are available on the ACT Health intranet and include:
Hand Tendon Repair Advice Handout and
Flexor Tendon Repair Early Active Movement (0-6 weeks) Handout
Looking after your scar Handout

The anticipated overall duration of the intervention weekly for the first 8 weeks then follow up at 3 and 6 months after tendon repair.
Interventions will be administered by and Senior Physiotherapist working in Hand Therapy with a minimum of 3 years experience
Compliance with orthosis wear, exercises and attendance with hand therapy will be discussed and recorded in a study-specific questionnaire weekly during the first 8 weeks of intervention.
Intervention code [1] 326600 0
Treatment: Devices
Comparator / control treatment
The dorsal blocking orthosis control group will wear the splint for 6 weeks full time.
Participants will perform daily exercises whilst in the splint as per the 'flexor tendon repair early active movement handout'.
The dorsal blocking orthosis will be weaned daily after 6 weeks for light activities and exercises only.

Weaning of the splint is not time limited but is limited to activities which are light in loading the flexor tendons. This information and a list of suitable light activities is listed in the handout provided called 'hand tendon repair advice handout'.

The dorsal blocking orthosis will be completely weaned at 8-9 weeks. Participants will then be asked to commence strengthening and return to usual activities of daily living.

Dorsal blocking orthosis control group will receive weekly wound care, scar management, education and exercises as part of standard care from their physiotherapist.
Wound care will be removal of handy gauze cohesive dressing, skin cleaning with saline solution and reapplication of handy gauze dressing, scar management will be education as per the 'looking after your scar' handout and further education and exercises as per the tendon repair advice and flexor tendon repair early active movement handouts

A Physiotherapist working in Hand Therapy will provide education to the participant which will personalised to participants based on their specific injury.
Education will include flexor tendon early active movement rehabilitation, involved structures, healing times, warnings, risks and precautions.

Handouts provided and discussed are available on the ACT Health intranet and include:
Hand Tendon Repair Advice Handout and
Flexor Tendon Repair Early Active Movement (0-6 weeks) Handout
Looking after your scar Handout

Exercise prescription includes active and passive movements (no more than half a fist for active movements) with the aim for patients to complete these independently, 6 sessions, 10 repetitions daily in a pain and stretch free range of movement.
Control group
Active

Outcomes
Primary outcome [1] 335926 0
Flexion range of motion (ROM) of the metacarpal phalangeal (MCP) joint using Jamar finger goniometer applying the standard testing procedure protocol
Timepoint [1] 335926 0
3 weeks, 6 weeks, 8 weeks, 12 weeks and 6 months post tendon repair surgery
Primary outcome [2] 336183 0
Flexion range of motion (ROM) of the proximal interphalangeal (PIP) joint using Jamar finger goniometer applying the standard testing procedure protocol
Timepoint [2] 336183 0
3 weeks, 6 weeks, 8 weeks, 12 weeks and 6 months post tendon repair surgery
Primary outcome [3] 336184 0
Flexion range of motion (ROM) of the distal interphalangeal (DIP) joint using Jamar finger goniometer applying the standard testing procedure protocol
Timepoint [3] 336184 0
3 weeks, 6 weeks, 8 weeks, 12 weeks and 6 months post tendon repair surgery
Secondary outcome [1] 426158 0
Patient perception of change using the Global Rating of Change Assessment
Timepoint [1] 426158 0
Weekly for 8 weeks then at 3 and 6 months post tendon repair surgery
Secondary outcome [2] 426159 0
Patient self reported disability through the Quick Disabilities of the Arm, Shoulder and Hand (DASH) Assessment
Timepoint [2] 426159 0
6 weeks, 12 weeks and 6 months post tendon repair surgery
Secondary outcome [3] 426160 0
Return to work: through a yes/no response recorded during a face-to-face appointment on a study-specific questionnaire.
Timepoint [3] 426160 0
Weekly for 8 weeks then at 3 and 6 months post tendon repair surgery
Secondary outcome [4] 426161 0
Minimum pain when completing exercises: using a numerical rating scale.
Timepoint [4] 426161 0
Weekly for 8 weeks then at 3 and 6 months post tendon repair surgery
Secondary outcome [5] 426162 0
Compliance with splinting full time and completing prescribed exercises: yes/no response recorded during face-to-face appointment on a study-specific questionnaire.
Timepoint [5] 426162 0
Weekly for 8 weeks then at 3 and 6 months post tendon repair surgery
Secondary outcome [6] 426163 0
Strength: measured with a Jamar hand grip dynamometer in kg/F and using standard testing procedure for hand grip assessment protocol.
Timepoint [6] 426163 0
12 weeks and 6 months post tendon repair surgery
Secondary outcome [7] 427235 0
Maximum pain when completing exercises: using a numerical rating scale.
Timepoint [7] 427235 0
Weekly for 8 weeks then at 3 and 6 months post tendon repair surgery
Secondary outcome [8] 427236 0
** PRIMARY OUTCOME** Feasibility of the study - number of suitable participants through daily audit of the plastics surgical list
Timepoint [8] 427236 0
Numeral, recorded on week days from the commencement of the study
Secondary outcome [9] 427239 0
** PRIMARY OUTCOME** Feasibility of the study - number of plastics operations performed through daily audit of the plastics surgical list
Timepoint [9] 427239 0
Numeral, recorded on week days from the commencement of the study
Secondary outcome [10] 427240 0
** PRIMARY OUTCOME** Feasibility of the study - time taken to audit the plastics surgical list
Timepoint [10] 427240 0
Time in minutes, recorded on weekdays from the commencement of the study
Secondary outcome [11] 427692 0
** PRIMARY OUTCOME** Extension range of motion (ROM) of the distal interphalangeal (DIP) joint using Jamar finger goniometer applying the standard testing procedure protocol
Timepoint [11] 427692 0
3 weeks, 6 weeks, 8 weeks, 12 weeks and 6 months post tendon repair surgery
Secondary outcome [12] 427693 0
** PRIMARY OUTCOME** Extension range of motion (ROM) of the proximal interphalangeal (PIP) joint using Jamar finger goniometer applying the standard testing procedure protocol
Timepoint [12] 427693 0
3 weeks, 6 weeks, 8 weeks, 12 weeks and 6 months post tendon repair surgery
Secondary outcome [13] 427694 0
** PRIMARY OUTCOME** Extension range of motion (ROM) of the metacarpal phalangeal (MCP) joint using Jamar finger goniometer applying the standard testing procedure protocol
Timepoint [13] 427694 0
3 weeks, 6 weeks, 8 weeks, 12 weeks and 6 months post tendon repair surgery

Eligibility
Key inclusion criteria
Male or females aged between 18-65 years.
Single digit sharp laceration injury of 1-2 FDP and/or FDS greater which is greater or equal to 50%.
Single or no digital nerve or vessel involved.
English speaking.
Able to attend weekly hand therapy appointments.
Able to complete early active movement regime as decided by the surgeon or hand therapist.
Digits 2-5 only.
Pulley venting at the discretion of the surgeon.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Thumb tendon injuries
Previous hand injury or impairment that significantly affects ROM and/or function.
Non-English speaking
Multiple digital nerve and vessels involved.

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)
Randomised number sequence generated by computer to provide the allocation according to permuted blocks of four (4)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/09/2023
Date of last participant enrolment
Anticipated
4/09/2024
Actual
Date of last data collection
Anticipated
4/03/2025
Actual
Sample size
Target
40
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 25491 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 41303 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 314373 0
Hospital
Name [1] 314373 0
Kerry Boyd, Canberra Health Services, The Canberra Hospital, Acute Allied Health Service Physiotherapy Manager
Country [1] 314373 0
Australia
Primary sponsor type
Government body
Name
ACT Health
Address
The Canberra Hospital, Hospital Road, Garran ACT 2606
Country
Australia
Secondary sponsor category [1] 316708 0
None
Name [1] 316708 0
Address [1] 316708 0
Country [1] 316708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313466 0
ACT Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 313466 0
Centre for Health and Medical Research, Research, Programs and Services Branch, ACT Health Directorate 2-6 Bowes St Phillip ACT 2606
Ethics committee country [1] 313466 0
Australia
Date submitted for ethics approval [1] 313466 0
17/11/2022
Approval date [1] 313466 0
30/06/2023
Ethics approval number [1] 313466 0

Summary
Brief summary
This study will be focused on adults 18-65 years who have partially or fully cut a singular tendon used to bend in the fingers and have had this tendon repaired by a surgeon.
The study is designed to compare two different types of splints used after a flexor tendon repair. Our primary purpose is to see if one splint allows patients to achieve greater range of movement earlier in their recovery than then other.
We hypothesise that a relative motion flexion splint will allow greater early recovery of finger movement compared to a dorsal blocking splint. During this study we will also be comparing when patients can return to work, patients' perceptions of their level of disability, pain, strength and ability to perform their usual activities of daily living.
Participants will be randomly assigned to either the relative motion or dorsal blocking splint group. Both groups will receive weekly hand therapy, scar management, education and exercises. Patients will be assessed on the study's primary outcome measure at 3, 6, 8, and 12 weeks and a blinded assessor will review patients at 6 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128262 0
Mrs Meryn Weenink
Address 128262 0
Physiotherapy Department, The Canberra Hospital, PO Box 11 Garran ACT 2606
Country 128262 0
Australia
Phone 128262 0
+61 251242154
Fax 128262 0
+61251243692
Email 128262 0
meryn.weenink@act.gov.au
Contact person for public queries
Name 128263 0
Mrs Meryn Weenink
Address 128263 0
Physiotherapy Department, The Canberra Hospital, PO Box 11 Garran ACT 2606
Country 128263 0
Australia
Phone 128263 0
+61 251242154
Fax 128263 0
+61251243692
Email 128263 0
meryn.weenink@act.gov.au
Contact person for scientific queries
Name 128264 0
Mr Michael Wilkinson
Address 128264 0
Physiotherapy Department, The Canberra Hospital, PO Box 11 Garran ACT 2606
Country 128264 0
Australia
Phone 128264 0
+61 251242154
Fax 128264 0
+61251243692
Email 128264 0
michael.wilkinson@act.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?

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.