Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000897561
Ethics application status
Approved
Date submitted
27/06/2024
Date registered
23/07/2024
Date last updated
23/07/2024
Date data sharing statement initially provided
23/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Do relative motion flexion orthoses improve proximal interphalangeal joint extension following traumatic finger injury or surgery? A randomised controlled trial
Scientific title
Do relative motion flexion orthoses improve proximal interphalangeal joint extension in adults following traumatic finger injury or surgery? A randomised controlled trial
Secondary ID [1] 312222 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Finger injury 333910 0
Finger surgery 333911 0
PIPJ movement restriction 333912 0
Rehabilitation 333913 0
Orthotic intervention 333914 0
Condition category
Condition code
Musculoskeletal 330584 330584 0 0
Other muscular and skeletal disorders
Injuries and Accidents 330585 330585 0 0
Fractures
Physical Medicine / Rehabilitation 330587 330587 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive the relative motion flexion orthosis, in addition to usual care (see below for details about control group).

The orthosis will be fabricated using TailorSplint thermoplastic material, and positioned with the affected finger metacarpophalangeal joint (MCPJ) in approximately 20 degrees of relative flexion, compared to adjacent fingers MCPJs. It will include three or four fingers in the design, as per hand therapist and patient decision to maximise adherence.

The orthosis will be fabricated during the 60-minute face-to-face consultation with the hand therapist at baseline. At least one face-to-face follow-up appointment will be scheduled within 1-2 weeks of orthosis provision to review the comfort of the orthosis and answer any questions about the therapy treatment. Therapists may choose to rebook the participant for additional sessions as they deem appropriate during the six-week study period, as per their discretion and clinical reasoning.

Participants will be guided by their therapist to wear the orthosis a minimum of four hours per day, during functional hand use and exercises. Adherence to the orthotic intervention will be recorded weekly using a paper patient diary, noting average orthotic wear-time and activities the orthosis was removed for.
Intervention code [1] 328673 0
Treatment: Other
Intervention code [2] 328674 0
Rehabilitation
Comparator / control treatment
The usual care group will receive usual therapy as per typical rehabilitation for proximal interphalangeal joint (PIPJ) extension deficit. This will continue for the six-week duration of the study.

The therapy modalities will be administered during the 60-minute face-to-face consultation with the hand therapist at baseline. At least one face-to-face follow up appointment will be scheduled within 1-2 weeks of initial appointment to address any queries they may have. Therapists may choose to rebook the participant for additional sessions as they deem appropriate during the six-week study period, as per their discretion and clinical reasoning.

Therapy modalities will include education about their injury and expected rehabilitation, a 5 minute heat treatment (heat pack or parrafin wax bath), 5 minutes of passive PIPJ extension stretching administered by the treating hand therapist, fabrication of a thermoplastic finger-based dorsal extension orthosis to be worn overnight, and fabrication of a compression sleeve to be worn day and night (removed for exercises and hand hygiene) in the presence of oedema. The night extension orthosis serves a different purpose to the relative motion orthosis, in that it is a static orthosis that is used to position one finger in an extended position and worn only overnight so not to interfere with daytime function.

In the therapy session, participants will also be educated and practice a series of exercises to be performed at home for 10 repetitions, 3-5 times daily. They will be asked to use heat prior to home exercises (such as warm water soak or application of a heat pack) for 5 minutes. It is expected that the heat treatment combined with exercise program will take 10 minutes in total (repeated 3-5 times daily). Exercises include passive proximal interphalangeal joint (PIPJ) extension stretching, blocked extension exercises, and tendon gliding exercises. Participants will be provided with an exercise sheet outlining these exercises.

Adherence to the night extension orthosis, home exercise program, and oedema control strategies will be monitored by the treating therapist at each follow up review, and any deviation from the treatment protocol or cessation of treatments will be documented.
Control group
Active

Outcomes
Primary outcome [1] 338342 0
Isolated active proximal interphalangeal joint extension
Timepoint [1] 338342 0
Baseline and six-weeks after commencement of intervention
Secondary outcome [1] 435490 0
Isolated passive proximal interphalangeal joint extension
Timepoint [1] 435490 0
Baseline and six-weeks after commencement of intervention.
Secondary outcome [2] 435491 0
Composite active finger extension / flexion of affected finger
Timepoint [2] 435491 0
Baseline and six-weeks after commencement of intervention
Secondary outcome [3] 435493 0
Total Active Motion of affected finger
Timepoint [3] 435493 0
Baseline and six-weeks after commencement of intervention
Secondary outcome [4] 435494 0
Percentage of total active motion of affected finger, compared to contralateral finger.
Timepoint [4] 435494 0
Baseline and six-weeks after commencement of intervention
Secondary outcome [5] 435495 0
Perception of change resulting from intervention
Timepoint [5] 435495 0
Six-weeks after commencement of intervention
Secondary outcome [6] 435496 0
Patient Rated Wrist and Hand Evaluation (PRWHE) questionnaire
Timepoint [6] 435496 0
Baseline and six-weeks after commencement of intervention
Secondary outcome [7] 435497 0
Patient Specific Functional Scale
Timepoint [7] 435497 0
Baseline and six-weeks after commencement of intervention
Secondary outcome [8] 435498 0
Visual Analogue Scale rating average pain over the last week
Timepoint [8] 435498 0
Baseline and six-weeks after commencement of intervention
Secondary outcome [9] 436066 0
Adverse events
Timepoint [9] 436066 0
Weekly until six-weeks after commencement of intervention

Eligibility
Key inclusion criteria
Participants will be eligible to participate in the trial if they:
- 18 years and over
- attending hand therapy following traumatic finger injury or surgery resulting in a >/= 20° active proximal interaphalangeal joint (PIPJ) extension deficit
- multi-digit injury (two or three injured fingers, with the finger with the greatest PIPJ deficit included)
- PIPJ movement restrictions resulting from hand injury not directly affecting the PIPJ but causing secondary stiffness due to immobilization.
- treating therapist deems it is clinically appropriate given the nature and stage of injury
- are able to provide written informed consent prior to enrolment in the study.
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 if they are attending therapy for:
- injury to all four fingers (as the relative motion orthosis cannot be used)
- Dupuytren’s contracture or post-contracture release surgery
- burns
- amputation
- trigger finger
- neurological condition as the primary cause of PIPJ movement restrictions
- inflammatory conditions as the primary cause of PIPJ movement restrictions
- previous injury to the same finger resulting in movement restrictions

They will also be excluded if the below apply:
- previous relative motion orthotic intervention for the current injury
- those unable to provide informed consent in English
- do not agree to follow up for treatment at a clinic participating in the trial.

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)
The hand therapists responsible for determining participants' eligibility to the trial will not have access to the randomisation schedule. One of the study investigators who is not involved in participant treatment or assessment will arrange the opaque envelopes based on the randomisation schedule. Randomisation will occur following screening and consent. The independent assessor will commence baseline assessment of participants prior to the treating therapist receiving allocation. The treating therapist is unblinded, and will be given the sequentially ordered opaque envelope specifying group allocation by a person not otherwise involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Before commencing study recruitment, a computer-generated random sequence stratified alphabetically by center (1 through 4) will be generated using Sealed Envelope Limited statistical software, using a 1:1 group allocation ratio calculated with random permuted block sizes and a list length of 100. An investigator who is not involved in recruitment and data collection will use this sequence to create 25 numbered opaque envelopes containing random group assignment for each of the four sites (100 in total). The sites will be blinded to block size and list length which will ensure selection bias is addressed.
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
Efficacy
Statistical methods / analysis
Using G*Power, we estimated that a sample size of 25 participants per group (50 participants total) will be required to detect a 9° proximal interphalangeal joint (PIPJ) extension difference between groups at 6-week follow up. An additional 6 participants will be recruited to allow for a 10% dropout in each group. This calculation used a PIPJ extension standard deviation of 11° for each group. The target difference of 9° represents the smallest detectable change for PIPJ extension based on the intra-rater standard error of measurement reported by Macionis.

Statistical analysis for the trial will be performed using an intention to treat approach. Primary analysis will compare range of motion and patient reported outcomes between groups mixed-effects models. Time, intervention, and time*intervention will be fixed effects. Participant will be a random effect. Statistical significance will be set at p<0.05. The effect of the intervention will be estimated as the mean difference in outcomes between groups at week 6 with 95% confidence interval. Descriptive statistics will be used to report orthosis wear time, opinions about the orthosis and activities it was removed for.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
1/08/2026
Actual
Date of last data collection
Anticipated
18/09/2026
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316601 0
Other
Name [1] 316601 0
Hand Therapy Group
Country [1] 316601 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 318942 0
None
Name [1] 318942 0
Address [1] 318942 0
Country [1] 318942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315385 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 315385 0
Ethics committee country [1] 315385 0
Australia
Date submitted for ethics approval [1] 315385 0
20/05/2024
Approval date [1] 315385 0
28/06/2024
Ethics approval number [1] 315385 0
520241733857696

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

Contacts
Principal investigator
Name 134534 0
Dr Joel Fuller
Address 134534 0
Department of Health Sciences, Faculty of Medicine, Health and Human Sciences. Ground Floor, 75 Talavera Road, Macquarie University, NSW, 2109
Country 134534 0
Australia
Phone 134534 0
+61 2 9850 4040
Fax 134534 0
Email 134534 0
[email protected]
Contact person for public queries
Name 134535 0
Joel Fuller
Address 134535 0
Department of Health Sciences, Faculty of Medicine, Health and Human Sciences. Ground Floor, 75 Talavera Road, Macquarie University, NSW, 2109
Country 134535 0
Australia
Phone 134535 0
+61 2 9850 4040
Fax 134535 0
Email 134535 0
[email protected]
Contact person for scientific queries
Name 134536 0
Joel Fuller
Address 134536 0
Department of Health Sciences, Faculty of Medicine, Health and Human Sciences. Ground Floor, 75 Talavera Road, Macquarie University, NSW, 2109
Country 134536 0
Australia
Phone 134536 0
+61 2 9850 4040
Fax 134536 0
Email 134536 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?
Individual participant data for all outcome measures will be available as de-identified data.
Meta-data will accompany this data set.
When will data be available (start and end dates)?
Data will be available after the results have been disseminated in a peer-reviewed journal. Anticipated December 2027. There is no end date.
Available to whom?
Access to this data will be conditional on approval from Dr Joel Fuller and ethical approval is provided. Dr Joel Fuller will be contactable at the following address and email:
Department of Medicine, Health and Health Sciences, Macquarie University. Ground Floor, 75 Talavera Road. Macquarie University NSW 2109
[email protected]
Available for what types of analyses?
Any purpose, as long as the data is deemed suitable to answer a specific research question and ethical approval is provided.
How or where can data be obtained?
Data will be available on the Macquarie Research Data Repository.
Queries concerning the IPD may be directed to Dr Joel Fuller, who will be contactable at the following address and email:
Department of Medicine, Health and Health Sciences, Macquarie University. Ground Floor, 75 Talavera Road. Macquarie University NSW 2109
[email protected]


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.