Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001402134
Ethics application status
Approved
Date submitted
17/09/2019
Date registered
14/10/2019
Date last updated
4/10/2022
Date data sharing statement initially provided
14/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The conservative management of stiffness and contractures in post-traumatic elbows
Scientific title
The efficacy of standard therapy with serial static extension orthoses versus standard treatment without orthoses on range of motion (ROM) and functional outcomes in post-traumatic elbow rehabilitation: a feasibility study of a randomised controlled trial
Secondary ID [1] 299262 0
Nil known
Universal Trial Number (UTN)
U1111-1240-1190
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic elbows 314400 0
Condition category
Condition code
Musculoskeletal 312735 312735 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 312736 312736 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A feasibility trial of a double-blinded randomised controlled trial (RCT) design. Participants with extension deficits in the subacute phase of post-traumatic elbow rehabilitation will be randomly allocated to either Treatment A (standard therapy without orthosis) or Treatment B (standard therapy with serial static extension orthosis). Participants in both Treatment A and B will undergo standard therapy, which includes six weekly therapy sessions and have a standardised home exercise program. Therapy sessions are administered by hand therapists (either occupational therapists or physiotherapists) and will last approximately 30-60 minutes. This will include the use of heat packs with weighted stretch, retrograde massage, scar tissue massage and exercises. The standardised home exercise program will done daily, 3-4 times a day. The exercises are progressed weekly as follows: Week 1 and 2 focused on elbow and shoulder ROM; Week 3 and 4 included additional light elbow strengthening exercises (0.5-1kg weights); Week 5 and 6 had ROM exercises, progressively weighted elbow exercises of 1.5-2kg and additional upper body strengthening with an elastic band. However, participants in Treatment B have additional serial static elbow orthoses. These orthoses will be remoulded in more extended positions during the weekly therapy sessions. Whilst this is based on the participant's level of comfort, the aim would be to progress to a fully extended position (0 degrees). The recommended orthotic wear-time is 6-12 hours per day, preferably overnight. Participants will be asked to keep a diary/logbook of their daily exercise and/or orthotic regime.
Intervention code [1] 315551 0
Treatment: Devices
Intervention code [2] 315552 0
Rehabilitation
Comparator / control treatment
Participants in the control group (standard therapy without orthoses) will undergo six weekly therapy sessions. Standard therapy will include the use of heat packs with weighted stretch, retrograde massage, scar tissue massage and a standardised home exercise program.
Control group
Active

Outcomes
Primary outcome [1] 321373 0
Composite primary outcome - Feasibility variables: The four main aims of the feasibility trial is to assess the process, resources, management and scientific basis of the planned RCT.
(1). The process assessment will identify the feasibility behind recruiting the participants within a set timeframe, such as the number of eligible patients, the participation rate and the dropout rate. Using a five-point Likert scale, a participant feedback form at the end of the 6-week study will assess the participants’ acceptance of the intervention and research protocol. Other areas of process assessment will include participant compliance to the weekly reviews and intervention protocol which will monitored using a diary.
(2) The resource assessment will identify the resources required, such as the number of hours required by the researchers and treating therapists for the trial, the cost of splinting materials, and identify any institutional barriers that may affect the progression of the study. Feasibility of both process and resources can be assessed by using a logbook method.
(3) Explore the strengths of the research protocol, including the research activities, in areas such as maintaining compliance in human participant ethics and data management process. Any adverse events or deviations from the standard protocol are recorded in the diary, checked weekly by the treating therapist, and further clarified by the accessor at the end of intervention.
(4). This feasibility trial will provide preliminary data on elbow extension active ROM (AROM) to generate an effect size for calculating power for a large-scale RCT.
Timepoint [1] 321373 0
Planned duration of study: 2.5 years
Goniometric assessment will be taken at baseline and 6-weeks post-trial assessments.
Primary outcome [2] 330823 0
Elbow Extension ROM:
Participants will undergo a “preconditioning” procedure for 15 minutes of heat treatment. After 5 minutes, a 500g handheld weight will be added for the remaining duration of the procedure. Standardised ROM measurements will then be performed. Active ROM (AROM) will first be recorded with the participant straightening the elbow maximally with their own strength, followed by extension PROM where an extension force is exerted by the investigator without causing pain. Preliminary data on extension AROM and PROM will be used to generate an effect size for calculating power for a large-scale RCT.
Timepoint [2] 330823 0
Baseline and at 6 weeks post intervention
Secondary outcome [1] 407729 0
Establishing reliability and validity of clinical tools evaluating elbow joint stiffness using Modified Weeks Test (MWT) - MWT will be calculated from the difference in passive ROM (PROM) before and after pre-conditioning the elbow joint with 15 minutes of heat pack and 500g weighted extension stretch. PROM is remeasured at the second assessment to establish the test-retest reliability. - Concurrent validity between the MWT and JEF will be established using a non-parametric analysis.
Timepoint [1] 407729 0
At baseline and measured within a few days
Secondary outcome [2] 407730 0
Consumer experience/variables influencing orthotic uptake:
Participants allocated to the Orthotic group will undergo a short semi-structured interview regarding their experience with the orthotic intervention.
Timepoint [2] 407730 0
Evaluated at 6 weeks post intervention
Secondary outcome [3] 407731 0
Exploring the usefulness of web-based software for rehabilitation. The study will providing data regarding uptake of software for rehabilitation programs. It will also compare the rates of therapy adherence between the two methods of rehab prescription: web-based software or traditional paper handout method.
Timepoint [3] 407731 0
All participants will access their therapeutic program and record their therapy adherence. over the course of the 6 week program. This is analysed at the end of the 6 week program.

Eligibility
Key inclusion criteria
- at least 18 years old
- 6-8 weeks post elbow trauma
- adequate fracture and/or ligamentous stability for passive ROM and use of mobilising orthosis
- elbow extension deficit of at least 20 degrees
- informed consent obtained
- able to comply to weekly review and structured rehabilitation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Heterotopic ossifications
- any inflammatory disease
- active infections
- wound-healing issues
- any neurological conditions (i.e. stroke, multiple sclerosis)
- burns-related contractures
- total elbow replacement
- complex regional pain syndrome or other widespread pain syndromes
- patients with cognitive impairments
- prior extension splinting

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site", i.e. the treating therapist (who will administer the 6-week intervention) will be informed of the allocation via phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). The principal researcher will randomise the participants using Sealed Envelope™, a web-based randomisation service.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
• Standardised measures will be scored. All baseline measures will be entered into SPSS and analysed using parametric or non-parametric statistics according to data type to access for difference between intervention groups.
• All diaries and logbook data will be summarised using descriptive statistics to address the feasibility of the study based on process, resources, management and scientific basis. A Likert scale in the participant feedback form can be summarised descriptively to provide feedback on process.
- Primary outcome measure regarding extension ROM will be analysed using non-parametric analysis. The means and confidence intervals for between group differences will then be used to generate an effect size using Cohen’s d. This effect size will be used for sample size calculations for a large RCT.
- Inter-rater reliability of the JEF will be measured using the percentage agreement of 2 assessors and the Kappa statistic.
• Test-retest reliability of the MWT will be analysed using Intra-class correlation coefficients [ICC (2,1)] and Bland Altman. Convergent validity between the MWT and JEF will be established using a non-parametric analysis.
• Due to the small sample size, data from the exercise and orthosis diaries will be analysed using non-parametric statistics for differences in therapy adherence between web-based software and traditional paper methods.
- Data from interviews will be transcribed and analysed using framework analysis. An inductive approach will be used to organize data with "open coding, creating categories and abstraction". Based on the focus on adherence to splinting, the Mutidimensional Adherence Model has been identified as a possible suitable framework for guiding analysis.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
2/01/2020
Actual
1/07/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
28/10/2021
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 28021 0
4000 - Brisbane
Recruitment postcode(s) [2] 28022 0
4101 - South Brisbane
Recruitment postcode(s) [3] 28023 0
4300 - Brookwater
Recruitment postcode(s) [4] 28024 0
4032 - Chermside
Recruitment postcode(s) [5] 28025 0
4011 - Clayfield
Recruitment postcode(s) [6] 28026 0
4171 - Hawthorne
Recruitment postcode(s) [7] 28027 0
4305 - Ipswich
Recruitment postcode(s) [8] 28028 0
4021 - Kippa-Ring

Funding & Sponsors
Funding source category [1] 303796 0
Charities/Societies/Foundations
Name [1] 303796 0
Australian Hand Therapy Association
Country [1] 303796 0
Australia
Primary sponsor type
Individual
Name
Chew Aik Sim
Address
EKCO Hand Therapy
1/600 Stanley Street
South Brisbane, QLD 4101, Australia
Country
Australia
Secondary sponsor category [1] 304059 0
University
Name [1] 304059 0
The University of Queensland
Address [1] 304059 0
Therapies Annexe (84A), The University of Queensland,
St Lucia QLD 4072, Australia
Country [1] 304059 0
Australia
Other collaborator category [1] 280971 0
Individual
Name [1] 280971 0
Dr Celeste Glasgow
Address [1] 280971 0
Senior Hand Therapist and Brookwater Clinic Coordinator, EKCO Hand Therapy, Brisbane.
Shop 8/2 Tournament Drive, Brookwater, QLD 4300, Australia
Country [1] 280971 0
Australia
Other collaborator category [2] 280972 0
Individual
Name [2] 280972 0
Prof Jennifer Fleming
Address [2] 280972 0
Therapies Annexe (84A), The University of Queensland, St Lucia QLD 4072, Australia
Country [2] 280972 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304315 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 304315 0
UQ Research & Innovation
Cumbrae Stewart Building (72)
The University of Queensland QLD 4072
Ethics committee country [1] 304315 0
Australia
Date submitted for ethics approval [1] 304315 0
16/09/2019
Approval date [1] 304315 0
11/11/2019
Ethics approval number [1] 304315 0
2019002325

Summary
Brief summary
This is a Phase II RCT study that will explore the effects of orthotic intervention in addition to standard therapy on stiff post-traumatic elbows. The purpose of this 6-week trial is to establish the feasibility of proceeding to a larger definitive RCT. This study will also establish the reliability and validity of 2 clinical tools (Modified Weeks Test and Joint End Feel) that will evaluate elbow joint stiffness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96506 0
Ms Chew Aik (Germaine) Sim
Address 96506 0
EKCO Hand Therapy
1/600 Stanley St,
South Brisbane,
Queensland 4101,
Australia
Country 96506 0
Australia
Phone 96506 0
+61 738460700
Fax 96506 0
Email 96506 0
[email protected]
Contact person for public queries
Name 96507 0
Ms Chew Aik (Germaine) Sim
Address 96507 0
EKCO Hand Therapy
1/600 Stanley St,
South Brisbane,
Queensland 4101,
Australia
Country 96507 0
Australia
Phone 96507 0
+61 738460700
Fax 96507 0
Email 96507 0
[email protected]
Contact person for scientific queries
Name 96508 0
Ms Chew Aik (Germaine) Sim
Address 96508 0
EKCO Hand Therapy
1/600 Stanley St,
South Brisbane,
Queensland 4101,
Australia
Country 96508 0
Australia
Phone 96508 0
+61 738460700
Fax 96508 0
Email 96508 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant confidentiality


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.