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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
Date results information initially provided
20/11/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Buddy strap versus splint in adults with boxer's fracture
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Scientific title
The effect on physical function of hand-based orthosis compared with buddy strapping in adults with fifth metacarpal neck fracture
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Secondary ID [1]
295636
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Nil known
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Universal Trial Number (UTN)
U1111-1217-9411
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
fifth metacarpal neck fracture
308971
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boxer's fracture
309144
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Condition category
Condition code
Injuries and Accidents
307869
307869
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0
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Fractures
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Physical Medicine / Rehabilitation
308029
308029
0
0
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Occupational therapy
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Physical Medicine / Rehabilitation
308030
308030
0
0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
302020
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Treatment: Devices
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Intervention code [2]
312073
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Rehabilitation
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Comparator / control treatment
buddy strapping
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Control group
Active
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Outcomes
Primary outcome [1]
306946
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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.
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Assessment method [1]
306946
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Timepoint [1]
306946
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commencement of intervention (baseline)
one week post commencement of intervention,
three weeks post commencement of intervention (primary endpoint)
six weeks post commencement of intervention
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Secondary outcome [1]
350191
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adverse event checklist: Complex regional pain syndrome, swelling, skin maceration, change in fracture alignment / malrotation
Checklist will be completed by the clinician
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Assessment method [1]
350191
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Timepoint [1]
350191
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commencement of intervention,
one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.
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Secondary outcome [2]
350194
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Pain score, as measured by visual analogue scale
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Assessment method [2]
350194
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Timepoint [2]
350194
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commencement of intervention,
one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.
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Secondary outcome [3]
350199
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range of motion of the fifth finger MCP joint as measured with a finger goniometer, using American Society of Hand Therapists (ASHT) protocol
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Assessment method [3]
350199
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Timepoint [3]
350199
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commencement of intervention,
one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.
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Secondary outcome [4]
350202
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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.
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Assessment method [4]
350202
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Timepoint [4]
350202
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one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.
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Secondary outcome [5]
350204
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Grip strength as measured by dynamometer, using American Society of Hand Therapists (ASHT) protocol
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Assessment method [5]
350204
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Timepoint [5]
350204
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six weeks post commencement of intervention
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Secondary outcome [6]
350360
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range of motion of the fifth finger PIP joint as measured with a finger goniometer, using American Society of Hand Therapists (ASHT) protocol
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Assessment method [6]
350360
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Timepoint [6]
350360
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commencement of intervention,
one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.
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Secondary outcome [7]
350361
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range of motion of the fifth finger DIP joint as measured with a finger goniometer, using American Society of Hand Therapists (ASHT) protocol
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Assessment method [7]
350361
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Timepoint [7]
350361
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commencement of intervention,
one week post commencement of intervention,
three weeks post commencement of intervention,
six weeks post commencement of intervention.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
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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.
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Date of first participant enrolment
Anticipated
15/08/2018
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Actual
20/08/2018
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Date of last participant enrolment
Anticipated
31/12/2021
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Actual
9/11/2022
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Date of last data collection
Anticipated
16/11/2022
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Actual
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Sample size
Target
110
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Accrual to date
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Final
63
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
11552
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Westmead Hospital - Westmead
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Recruitment hospital [2]
25875
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Auburn Hospital & Community Health Services - Auburn
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Recruitment postcode(s) [1]
23580
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2145 - Westmead
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Recruitment postcode(s) [2]
41708
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2144 - Auburn
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Funding & Sponsors
Funding source category [1]
300219
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Charities/Societies/Foundations
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Name [1]
300219
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Australian Hand Therapy Association
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Address [1]
300219
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PO Box 5111
West Busselton, WA 6280
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Country [1]
300219
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Australia
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Primary sponsor type
Individual
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Name
Tracey Clark
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Address
Physiotherapy Department
Westmead Hospital
PO Box 533
Wentworthville NSW 2415
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Country
Australia
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Secondary sponsor category [1]
299628
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Hospital
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Name [1]
299628
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Westmead Hospital
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Address [1]
299628
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Westmead Hospital
PO Box 533
Wentworthville NSW 2415
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Country [1]
299628
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301041
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Western Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
301041
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Research Office, Level 2, REN Building
Westmead Hospital
Hawkesbury & Darcy Roads, Westmead NSW 2145
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Ethics committee country [1]
301041
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Australia
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Date submitted for ethics approval [1]
301041
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15/11/2017
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Approval date [1]
301041
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18/05/2018
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Ethics approval number [1]
301041
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HREC/17/WMEAD/553
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Summary
Brief summary
Fifth metacarpal neck fracture is a condition commonly referred to hand therapists for management. The method of treatment provided, as well as the frequency and duration of treatment vary widely, due to a lack of conclusive research evidence.
This project will determine which of two treatment methods commonly employed by hand therapists is the most effective for the management of fifth metacarpal neck fracture. The findings of this project will enable therapists to decide with confidence which treatment method will produce the most satisfactory functional outcome and is preferred by patients.
The results are expected to have implications for decision making about the resources allocated to this condition in the future, both in terms of therapist’s time and expertise, as well as materials used.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
85678
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Ms Tracey Clark
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Address
85678
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Physiotherapy Department
PO Box 533
Wentworthville NSW 2145
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Country
85678
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Australia
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Phone
85678
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+61288906500
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Fax
85678
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Email
85678
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[email protected]
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Contact person for public queries
Name
85679
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Ms Tracey Clark
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Address
85679
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Physiotherapy Department
PO Box Box 533
Wentworthville NSW 2145
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Country
85679
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Australia
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Phone
85679
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+61288906500
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Fax
85679
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Email
85679
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[email protected]
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Contact person for scientific queries
Name
85680
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Ms Tracey Clark
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Address
85680
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Physiotherapy Department
PO Box Box 533
Wentworthville NSW 2145
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Country
85680
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Australia
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Phone
85680
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+61288906500
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Fax
85680
0
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Email
85680
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
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When will data be available (start and end dates)?
start date:Immediately following publication
No end date determined
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Available to whom?
only researchers who provide a methodologically sound proposal
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Available for what types of analyses?
IPD meta-analyses
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How or where can data be obtained?
access subject to approvals by Principal Investigator
[email protected]
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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.
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