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Trial registered on ANZCTR


Registration number
ACTRN12615000043538
Ethics application status
Approved
Date submitted
17/12/2014
Date registered
21/01/2015
Date last updated
19/08/2019
Date data sharing statement initially provided
19/08/2019
Date results provided
19/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can relative motion extension splinting provide an earlier return to hand function than a controlled active motion protocol after extensor tendon repair in zone V and VI? A prospective randomised clinical trial
Scientific title
A randomized clinical trial comparing early active motion
programs: Earlier hand function, TAM, and orthotic satisfaction
with a relative motion extension program for zones V and VI
extensor tendon repairs
Secondary ID [1] 285863 0
Nil
Universal Trial Number (UTN)
U1111-1162-9133
Trial acronym
RMES vs Ext CAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensor tendon laceration 293775 0
Condition category
Condition code
Physical Medicine / Rehabilitation 294080 294080 0 0
Occupational therapy
Surgery 294081 294081 0 0
Other surgery
Injuries and Accidents 294186 294186 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who have undergone extensor tendon repair in zone V and/or VI will be randomised post-operatively into either a group who receive the usual rehabilitation protocol of controlled active motion, or an experimental group who will be treated using a relative motion extension splinting protocol- this uses an alternative splint and exercise programme.

The splint in the intervention group includes only the MCP joints rather than the MCPs, wrist and forearm, and positions the injured MCP joint (s) in 15-20 degrees relative extension to the other digits.
In the first 4 weeks no specific exercises are provided, the patient is advised to move the hand and use it for light activities in the splint. From 4 weeks the patient will be provided with customised exercises to reduce a lag if one exists, such as active MCP extension and place and hold in extension, and tendon gliding exercises if there is a limitation in flexion. These are usually around 10 repetitions 5 times per day but will be adapted to the patient. From 8 weeks passive flexion stretches 5 times per day may be included if necessary to regain flexion. Patients will also be advised on the use of heat and massage at home
The hand therapist (OT or physio) will teach the exercises and advise the patient on the use of the hand at home; they may use modalities such as heat and massage in therapy sessions.
Consultation will be one-on-one sessions. Usually the first session will be for 1 hour and subsequent sessions 30 minutes each, 1 -2 times per week for the first 4-6 weeks and then once every 1-2 weeks after this until approximately 8 -10 weeks post-operatively. Frequency and duration of sessions will be customised to the individual patients needs and are not dictated by the study protocol.
Adherence to splinting will be assessed by the therapist treating the participant and a splinting questionnaire will be completed at the 4 week mark.
Intervention code [1] 290842 0
Rehabilitation
Intervention code [2] 290927 0
Treatment: Devices
Comparator / control treatment
The comparator is the group who will receive the controlled active motion protocol that is the usual post-operative rehabilitation regime at this unit.
This splint includes the forearm, wrist and all digits and only allows motion at the IP joints
In weeks 1-4 patients are advised on active flexion/ extension of IP joints within the confines of the splint, and place and hold of MCP into extension; in weeks 4-6, tendon gliding exercises and wrist extension/ flexion are commenced. If there is a limitation in flexion then at 8 weeks passive flexion of the digits will be introduced. Usual exercise frequency is 5 times per day, 10 repetitions, but this will be adapted to suit the individual. Patients will also be advised on the use of heat and massage at home

The hand therapist (OT or physio) will teach the exercises and advise the patient on the use of the hand at home; they may use modalities such as heat and massage in therapy sessions.
Consultation will be one-on-one. Usually the first session will be for 1 hour and subsequent sessions 30 minutes each, 1 -2 times per week for the first 4-6 weeks and then once every 1-2 weeks after this until approximately 8 -10 weeks post-operatively. Frequency and duration of sessions will be customised to the individual patients needs and are not dictated by the study protocol.

Adherence to splinting will be assessed by the therapist treating the participant and a splinting questionnaire will be completed at the 4 week mark.
Control group
Active

Outcomes
Primary outcome [1] 293868 0
Sollerman hand function assessment score
Timepoint [1] 293868 0
4 and 8 weeks post-operatively
Secondary outcome [1] 312035 0
QuickDASH score - participant's subjective assessment of their hand function and ability to perform everyday tasks
Timepoint [1] 312035 0
4 and 8 weeks post-op
Secondary outcome [2] 312036 0
Days to return to work after surgery; the treating therapist will record the date that the participant returns to work and inform the investigating team
Timepoint [2] 312036 0
Throughout the 8 weeks of the study
Secondary outcome [3] 312037 0
Range of motion using a manual finger goniometer
Timepoint [3] 312037 0
4 weeks and 8 weeks post-op
Secondary outcome [4] 312038 0
Grip strength using a handheld manual Jamar dynamometer
Timepoint [4] 312038 0
8 weeks post-op
Secondary outcome [5] 312039 0
Splinting adherence questionnaire - this is an adaptation of a questionnaire used in a previous study on patient adherence to splinting after tendon repair
Timepoint [5] 312039 0
4 weeks post-op
Secondary outcome [6] 312040 0
Satisfaction questionnaire - this is adapted from the Patient Evauluation Measure (PEM) published by Dias and Braybrooke
Timepoint [6] 312040 0
8 weeks post-op

Eligibility
Key inclusion criteria
Patients undergoing extensor tendon repair to at least one digit in zone V and/or VI through CMDHB
Simple tendon lacerations of 50-100% of the tendon substance as assessed intra-operatively by surgeon
Participants must be able to attend follow-up
Participants must be able to understand English or have an interpreter available
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Complex injuries involving unstable fractures or concurrent flexor tendon injury
Extensor tendon repairs to three or more digits
‘Fight bites’ or infected injuries which cannot be primarily repaired
Thumb extensor tendon repairs
Any factor which would make the patient unsuitable for inclusion in the view of the treating surgeon or investigator such as a tenuous tendon repair or concerns over patients’ ability to adhere to 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)
Potential participants will be identified by hand physiotherapists while they are in Middlemore Hospital, where they will undergo surgery. Those identified that meet the inclusion criteria will be provided with the participant information sheet whilst they are in hospital. The physiotherapists will ensure that these potential participants have their first outpatient hand therapy appointment booked at the hand therapy department of Manukau SuperClinic (MSC), the outpatient clinic of CMDHB, within the first week after surgery. At this appointment participants will be consented by the treating therapist and randomised by selecting a sealed envelope containing a slip of paper indicating Group A (extensor CAM protocol) or Group B (RMES protocol).
Participants will be referred to their community hand therapist for follow-up therapy. Training in the research protocol will be provided to all therapists who will treat the participants. Participants will be requested to attend assessment appointments at 4 and 8 weeks post-op at the hand therapy department of MSC. Each session will take approximately 60 minutes and where possible these appointments will be co-ordinated with the participants’ surgical review which also takes place at MSC. Funding will be sought to reimburse participants for fuel costs.
Due to the nature of the study it will not be possible to blind the patients to group allocation as the splints for the two protocols are very different in appearance. It will also not be possible to fully blind the assessor as the Sollerman hand function assessment will be performed with the splint in situ at 4 weeks in order to assess how well the participant can use their hand with the splint on. In order to provide partial blinding, an assistant will carry out randomisation of the participants and recording of group allocation and this will not be revealed to the primary investigator. At the 4 and 8 week assessment sessions, the same assistant will carry out the Sollerman hand function assessment in a closed room without the primary investigator. Once the Sollerman hand function assessment is completed the participant will remove the splint and conceal it from view. The primary investigator will then enter and assess the remaining outcomes. Group allocation will only be revealed to the primary investigator once all data for all participants have been collected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Half of the sealed envelopes will contain a slip of paper indicating group A and the other half will indicate Group B. This is a type of block randomisation as there will be equal numbers of each group. Participants will choose a sealed envelope without knowing which slip of paper it contains.
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
Safety/efficacy
Statistical methods / analysis
Calculation of sample size was undertaken with the assistance of a CMDHB biostatistician, Irene Zeng. No previous data have been published using the Sollerman hand function assessment as the primary outcome for patients with zone V/VI extensor tendon repairs. A recent study used the Sollerman hand function assessment to evaluate patients recovering from a distal radius fracture (Porter, 2013). This provided an estimation of data variability in a patient population who had sustained a traumatic injury to an upper limb, albeit an alternative diagnosis. Data from this study were used to calculate a coefficient of variation. In addition, preliminary testing of the Sollerman was carried out with a group of healthy volunteers from the CMDHB hand therapy department wearing the splints from the two protocols to determine a likely difference in scores between groups. Using the coefficient of variation derived from the distal radius study (13.3%), and the difference in mean scores calculated from the healthy volunteers (10 points), a proposed sample size was derived. With equivalent group sizes, 90% statistical power, 5% type I error and a derived standard deviation of 8.5 and 7.2 respectively for the RMES and extensor CAM groups, it is estimated that each group requires 13 participants. Expected drop-out rate is 30% (Hall et al., 2010) which indicates that 40 patients are required for the total sample. Over the year from June 2012 –May 2013 just over 50 patients who would have met the inclusion criteria were operated on in CMDHB, this is therefore considered an achievable sample size for the study duration.Analysis of the differences in the objective and subjective measures of hand function, number of days to return to work in any capacity, grip strength, range of motion, satisfaction and adherence between control and intervention groups at 4 and at 8 weeks will be carried out by means of a [generalised] mixed linear model [depending on the distribution of the data]. Intervening variables such as gender and ethnicity will be controlled for separately and jointly where appropriate. The frequency distribution of complications in both groups will be compared by a Chi-square test of independence or Fisher exact test depending on the type of data and sample size. Correlations between the objective and subjective measures of hand function and range of motion scores will be investigated using a Pearson correlation coefficient or a Spearman’s rank order correlation, depending on the data, and a Bland-Altman plot will be constructed to assess agreement between the measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/01/2015
Actual
16/02/2015
Date of last participant enrolment
Anticipated
1/05/2016
Actual
19/02/2016
Date of last data collection
Anticipated
Actual
15/04/2016
Sample size
Target
40
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 6551 0
New Zealand
State/province [1] 6551 0
Auckland

Funding & Sponsors
Funding source category [1] 290437 0
Hospital
Name [1] 290437 0
Counties Manukau District Health Board
-Plastics Department
-Ko Awatea
Country [1] 290437 0
New Zealand
Funding source category [2] 290438 0
Charities/Societies/Foundations
Name [2] 290438 0
New Zealand Association of Occupational Therapists
Country [2] 290438 0
New Zealand
Funding source category [3] 290439 0
Charities/Societies/Foundations
Name [3] 290439 0
New Zealand Association of Hand Therapists
Country [3] 290439 0
New Zealand
Funding source category [4] 290440 0
University
Name [4] 290440 0
Auckland University of Technology (AUT)
Country [4] 290440 0
New Zealand
Primary sponsor type
Individual
Name
Shirley Collocott
Address
Hand Therapy Department
Module 5
Manukau SuperClinic
901 Great South Road
Manukau
1640
Country
New Zealand
Secondary sponsor category [1] 289150 0
None
Name [1] 289150 0
Address [1] 289150 0
Country [1] 289150 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292118 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 292118 0
Ethics committee country [1] 292118 0
New Zealand
Date submitted for ethics approval [1] 292118 0
22/10/2014
Approval date [1] 292118 0
05/11/2014
Ethics approval number [1] 292118 0
14/STH/164
Ethics committee name [2] 292119 0
AUTEC
Ethics committee address [2] 292119 0
Ethics committee country [2] 292119 0
New Zealand
Date submitted for ethics approval [2] 292119 0
10/11/2014
Approval date [2] 292119 0
18/11/2014
Ethics approval number [2] 292119 0
14/377

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

Contacts
Principal investigator
Name 53602 0
Mrs Shirley Collocott
Address 53602 0
Hand Therapy Department
Module 5
Manukau SuperClinic
901 Great South Road
Manukau
1640
Country 53602 0
New Zealand
Phone 53602 0
+64 21 075 107
Fax 53602 0
Email 53602 0
shirley.collocott@middlemore.co.nz
Contact person for public queries
Name 53603 0
Shirley Collocott
Address 53603 0
Hand Therapy Department
Module 5
Manukau SuperClinic
901 Great South Road
Manukau
1640
Country 53603 0
New Zealand
Phone 53603 0
+64 21 075 107
Fax 53603 0
Email 53603 0
shirley.collocott@middlemore.co.nz
Contact person for scientific queries
Name 53604 0
Shirley Collocott
Address 53604 0
Hand Therapy Department
Module 5
Manukau SuperClinic
901 Great South Road
Manukau
1640
Country 53604 0
New Zealand
Phone 53604 0
+64 21 075 107
Fax 53604 0
Email 53604 0
shirley.collocott@middlemore.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified outcome data
When will data be available (start and end dates)?
Start date: 24/09/2018
No end date determined
Available to whom?
To subscribers to Mendeley
Available for what types of analyses?
It depends on what researchers would like to analyse
How or where can data be obtained?
It is available on Mendeley


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
SourceTitleYear of PublicationDOI
EmbaseA randomized clinical trial comparing early active motion programs: Earlier hand function, TAM, and orthotic satisfaction with a relative motion extension program for zones V and VI extensor tendon repairs.2020https://dx.doi.org/10.1016/j.jht.2018.10.003
N.B. These documents automatically identified may not have been verified by the study sponsor.