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Trial registered on ANZCTR


Registration number
ACTRN12618001324202
Ethics application status
Approved
Date submitted
31/07/2018
Date registered
7/08/2018
Date last updated
20/11/2023
Date data sharing statement initially provided
21/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Buddy strap versus splint in adults with boxer's fracture
Scientific title
The effect on physical function of hand-based orthosis compared with buddy strapping in adults with fifth metacarpal neck fracture
Secondary ID [1] 295636 0
Nil known
Universal Trial Number (UTN)
U1111-1217-9411
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fifth metacarpal neck fracture 308971 0
boxer's fracture 309144 0
Condition category
Condition code
Injuries and Accidents 307869 307869 0 0
Fractures
Physical Medicine / Rehabilitation 308029 308029 0 0
Occupational therapy
Physical Medicine / Rehabilitation 308030 308030 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. hand based orthosis - which is a custom molded thermoplastic splint commonly used for the management of hand and wrist fractures
2. buddy strapping - alternatively known as neighbour strapping, consisting of velcro fabric used commonly to keep one finger strapped to the adjacent finger for support

Hand based orthosis group will be fitted with a custom-moulded thermoplastic hand splint, which will hold the 4th and 5th knuckles in a 70 degrees flexed position, leaving the finger joints free. The orthosis will be secured to the hand using three Velcro straps. Orthosis will be fitted at the time of inclusion. Orthosis group will be instructed to remove orthosis for light functional activities, from the 3 week visit, and discard the orthosis at 5 weeks.
Buddy strapping group will be fitted with two soft fabric and Velcro buddy straps, which will be used to splint the fifth finger to the fourth finger. Buddy strap will be fitted at the time of inclusion. Buddy strap group will be instructed to commence light functional activity as tolerated. Participants will be instructed to wear buddy straps daily for 5 weeks.
Both groups will be instructed to remove their device for skin hygiene daily.
Study interventions will be performed by Physiotherapists and Occupational Therapists.
All participants will be followed for six weeks. Clinical assessments will occur at the time of inclusion, one week, three weeks and six weeks. Each participant will see their treating physiotherapist or occupational therapist first to check device fit, and to monitor compliance with the device. Compliance will be monitored by asking the participant if they have been wearing the device. The therapist will then remove the device to allow blinded assessment by a research assistant (Physiotherapist or Occupational therapist).
Each intervention will take place in the hand therapy treatment room of the Westmead Hospital Allied Health Department; will be delivered face to face and will be 30 minutes in duration.
Intervention code [1] 302020 0
Treatment: Devices
Intervention code [2] 312073 0
Rehabilitation
Comparator / control treatment
buddy strapping
Control group
Active

Outcomes
Primary outcome [1] 306946 0
QuickDASH score.
QuickDASH a self-administered questionnaire which uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.
Timepoint [1] 306946 0
commencement of intervention (baseline)
one week post commencement of intervention,
three weeks post commencement of intervention (primary endpoint)
six weeks post commencement of intervention
Secondary outcome [1] 350191 0
adverse event checklist: Complex regional pain syndrome, swelling, skin maceration, change in fracture alignment / malrotation
Checklist will be completed by the clinician
Timepoint [1] 350191 0
commencement of intervention,
one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.
Secondary outcome [2] 350194 0
Pain score, as measured by visual analogue scale
Timepoint [2] 350194 0
commencement of intervention,
one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.
Secondary outcome [3] 350199 0
range of motion of the fifth finger MCP joint as measured with a finger goniometer, using American Society of Hand Therapists (ASHT) protocol
Timepoint [3] 350199 0
commencement of intervention,
one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.
Secondary outcome [4] 350202 0
Patient satisfaction, as measured by Michigan Hand Outcomes Questionnaire. The MHQ has 37 core questions, takes approximately 15 minutes to complete and can be self-administered. The whole questionnaire is being administered to participants.
Timepoint [4] 350202 0
one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.
Secondary outcome [5] 350204 0
Grip strength as measured by dynamometer, using American Society of Hand Therapists (ASHT) protocol
Timepoint [5] 350204 0
six weeks post commencement of intervention
Secondary outcome [6] 350360 0
range of motion of the fifth finger PIP joint as measured with a finger goniometer, using American Society of Hand Therapists (ASHT) protocol
Timepoint [6] 350360 0
commencement of intervention,
one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.
Secondary outcome [7] 350361 0
range of motion of the fifth finger DIP joint as measured with a finger goniometer, using American Society of Hand Therapists (ASHT) protocol
Timepoint [7] 350361 0
commencement of intervention,
one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.

Eligibility
Key inclusion criteria
Adults who present to Westmead Hospital with a fracture of the fifth metacarpal neck, and who have been assessed by medical staff as suitable for non-operative treatment, will be included in the study. Inclusion Criteria will be: Volar angulation of fracture up to 70 degrees, as measured from the lateral x-ray; and no fracture rotation. To assess rotation, the referrer will compare the affected and contralateral hands. Normally, all fingers point to scaphoid tubercle, and deviation from this alignment may indicate a rotated fracture fragment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children and people with an intellectual or mental impairment have been excluded from this research study because of their potential inability to provide written and informed consent. This group may also be unable to understand and actively participate in the treatment protocol.

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 blocks of four by gender
Two envelopes will be used. One for male participants, one for female participants. Each envelope will contain four smaller sealed opaque envelopes: 2x treatment A and 2x treatment B. Sealed envelopes will be randomly allocated until exhausted and then replaced with an additional block of four. Participants will be numbered sequentially.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a difference of 16 points in the QuickDASH, the sample size of 50 patients per treatment group was calculated with a power (1-ß) of 80 percent and a type I error (a) of 5 percent. A total of 110 patients will be recruited, to allow for a 10% drop-out rate.
Descriptive statistics will be used to analyse the demographic data
2 group unpaired t test will be used to analyse numerical data
Chi-square test will be used to analyse categorical data
Data analysis will be carried out according to the intention-to-treat principle.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Slower than anticipated recruitment prompted interim blinded statistical analysis of data, which demonstrated no significant difference between groups for primary or secondary outcome measures and no likelihood of achieving significance by continuing to recruit to the proposed number of participants.
Date of first participant enrolment
Anticipated
15/08/2018
Actual
20/08/2018
Date of last participant enrolment
Anticipated
31/12/2021
Actual
9/11/2022
Date of last data collection
Anticipated
16/11/2022
Actual
Sample size
Target
110
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11552 0
Westmead Hospital - Westmead
Recruitment hospital [2] 25875 0
Auburn Hospital & Community Health Services - Auburn
Recruitment postcode(s) [1] 23580 0
2145 - Westmead
Recruitment postcode(s) [2] 41708 0
2144 - Auburn

Funding & Sponsors
Funding source category [1] 300219 0
Charities/Societies/Foundations
Name [1] 300219 0
Australian Hand Therapy Association
Country [1] 300219 0
Australia
Primary sponsor type
Individual
Name
Tracey Clark
Address
Physiotherapy Department
Westmead Hospital
PO Box 533
Wentworthville NSW 2415
Country
Australia
Secondary sponsor category [1] 299628 0
Hospital
Name [1] 299628 0
Westmead Hospital
Address [1] 299628 0
Westmead Hospital
PO Box 533
Wentworthville NSW 2415
Country [1] 299628 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301041 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301041 0
Ethics committee country [1] 301041 0
Australia
Date submitted for ethics approval [1] 301041 0
15/11/2017
Approval date [1] 301041 0
18/05/2018
Ethics approval number [1] 301041 0
HREC/17/WMEAD/553

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

Contacts
Principal investigator
Name 85678 0
Ms Tracey Clark
Address 85678 0
Physiotherapy Department
PO Box 533
Wentworthville NSW 2145
Country 85678 0
Australia
Phone 85678 0
+61288906500
Fax 85678 0
Email 85678 0
[email protected]
Contact person for public queries
Name 85679 0
Tracey Clark
Address 85679 0
Physiotherapy Department
PO Box Box 533
Wentworthville NSW 2145
Country 85679 0
Australia
Phone 85679 0
+61288906500
Fax 85679 0
Email 85679 0
[email protected]
Contact person for scientific queries
Name 85680 0
Tracey Clark
Address 85680 0
Physiotherapy Department
PO Box Box 533
Wentworthville NSW 2145
Country 85680 0
Australia
Phone 85680 0
+61288906500
Fax 85680 0
Email 85680 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?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
start date:Immediately following publication
No end date determined
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator
[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.