Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000339459
Ethics application status
Approved
Date submitted
8/03/2016
Date registered
16/03/2016
Date last updated
17/12/2019
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of a workplace-based hand therapy intervention on the return to work and clinical outcomes of injured workers with Lateral Elbow Tendinopathy.
Scientific title
The impact of a workplace-based hand therapy intervention on the return to work and clinical outcomes of injured workers with Lateral Elbow Tendinopathy.
Secondary ID [1] 288265 0
Nil known
Universal Trial Number (UTN)
U1111-1178-2539
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lateral Elbow Tendinopathy 297210 0
Condition category
Condition code
Musculoskeletal 298104 298104 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention exposure is an additional workplace visit (to the usual clinic based treatment) by the treating hand therapists within the first four weeks of the initial appointment to identify risk factors associated with LE and provide specific education on pathology, activity modification, postures to avoid and recommendations tailored specifically to the patient in their workplace. The duration of this work site visit will be one hour. There is a work site visit form that will be used by all hand therapists when completing this work site visit. There are four common steps for all hand therapists to follow: (1) Identify the activities that the patient has difficulty at work (2) Assess the risk factors for LE in the workplace (3) Provide and demonstrate specific work recommendations to reduce the risk factors (4) Educate and inform the appropriate key parties.
Intervention code [1] 294143 0
Treatment: Other
Comparator / control treatment
The control group are those patients that receive normal hand therapy clinic-based treatment only. These treatments for LE are completed in the workplace and include prescription of orthoses, eccentric exercises, heat, soft tissue therapy and in clinic education on pathology and positions to avoid.
Control group
Active

Outcomes
Primary outcome [1] 297615 0
Durable Return to Work
Timepoint [1] 297615 0
This outcome will be measured from the day the patient receives a workers compensation claim (first medical certificate) to the day the claim is closed (final certificate from the medical practitioner). This outcome measure will be assessed by data linkage to workers compensation records.
Primary outcome [2] 297671 0
Claims Cost
Timepoint [2] 297671 0
This outcome will be measured from the day the patient receives a workers compensation claim (first medical certificate) to the day the claim is closed (final certificate from the medical practitioner). This outcome measure will be assessed by data linkage to workers compensation records.
Primary outcome [3] 297672 0
Claim Duration
Timepoint [3] 297672 0
This outcome will be measured from the day the patient receives a workers compensation claim (first medical certificate) to the day the claim is closed (final certificate from the medical practitioner). This outcome measure will be assessed by data linkage to workers compensation records.
Secondary outcome [1] 321593 0
Pain
Timepoint [1] 321593 0
Pain will be measured at the initial appointment, 6 weeks, 12 weeks and a follow up 1 year mark after the initial appointment using the Visual Analogue Scale.
Secondary outcome [2] 321772 0
Pain-free Grip Strength
Timepoint [2] 321772 0
This outcome will be assessed at the initial, 6 week and 12 week and a follow up 1 year mark after the initial appointment using a calibrated Jamar Dynamometer.
Secondary outcome [3] 321773 0
Function
Timepoint [3] 321773 0
Function will be assessed using the Patient Related Tennis Elbow Evaluation Assessment at the initial, 6 week and 12 week and 1 year mark after the initial appointment.

Eligibility
Key inclusion criteria
Inclusion criteria:
*Male or female
*Aged 18 to 65 years of age
*Clinically diagnosed with LE characterised by pain reproduced on at least 2/5 of these clinical tests: (1) resisted middle finger test (2) resisted wrist extension (3) resisted supination (4) palpation over LE (5) palpation over CETO
*Submitted a claim for worker’s compensation related to LE
*Unilateral only
*Can be acute or chronic patients (Acute= <3 months of symptoms, Chronic= >3 months)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have had any of the following in the past 6 months:
*Corticosteroid injection
*Blood injections (ABI, PRP)
*Previous surgeries for the management of LE
*Workers’ compensation claim is declined
*Has other upper limb injuries
*If the patient works FIFO or in rural setting (whereby a worksite visit would not be possible)
*Does not speak or understand English
*Are unable to return to work duties due to intense LE symptoms
*Are unable to return to work on alternative work duties

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)
There will be 50 pre-prepared opaque envelopes with n=25 that have a "Group A" and n=25 that have a "Group B" token in it. Group A= control group and Group B= Intervention group. These envelopes are held by the admin staff member. The allocation envelopes will be kept secret from the clinical staff who are directly involved in the trial so they are blinded to the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To get around the issue of the simple random allocation ending up with an imbalance of numbers on each side of the fence, Block randomisation will be used. The admin staff will start off with 30 mixed up opaque envelopes (15 Group A and 15 Group B). Once the treating hand therapist gain consent from the patient to be in the study, they will inform the admin staff member. The admin staff member will randomly pick out 1 of the 30 envelopes to allocate that patient into Group A or B. Once all 30 envelopes are distributed, then the next block of 20 will be used. This will continue until the desired 50 envelopes are distributed.
This process will continue until the desired 50 envelopes are distributed. So far we have started with 30 mixed opaque envelopes. Once this is used up, we will add in an extra 20 mixed opaque envelopes (10 Group A and 10 Group B) to make it a total of 50.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Statistical Package for the Social Sciences (SPSS, v. 22) will be used to perform data analysis. The level of statistical significance (P value) will be set at 0.05 for all statistical tests, allowing for a 5% risk of a Type-I error. Week 0 baseline demographics between the control and intervention groups will be compared to determine any differences.

The differences in claims costs and claims duration between the comparison and experiment groups will be analysed using relevant parametric/non-parametric inferential statistics (e.g. independent t-tests, Mann-Whitney U tests, regression analyses to control for confounding factors).

The differences in pain levels, grip strength and between the comparison and experiment group will be analysed by:
*Having continuous data compared;
*The best, worst and average visual analogue pain, grip strength and PRTEE scores and measurements will be calculated;
*Repeated measures two-way ANOVA will be used to test for any significant differences (p<0.05) which will result within and between the comparison and experimental groups for all outcome measures; and
*The researcher performing the analysis will be blinded to whether data are from group A or B until after the data are analysed.

Intention-to-treat analysis will be used to deal with data from any participants who drop out of the study or do not comply with the interventions to which they are allocated.

The study has now changed to a pilot study with an aim to recruit N=50. The purpose of a pilot trial would be to get some information about expected effect size, which includes some information about the standard deviation for each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/04/2016
Actual
18/04/2016
Date of last participant enrolment
Anticipated
15/12/2019
Actual
30/03/2019
Date of last data collection
Anticipated
Actual
30/03/2019
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 293069 0
University
Name [1] 293069 0
Curtin University
Country [1] 293069 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of OT and Social Work
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 291861 0
None
Name [1] 291861 0
NONE
Address [1] 291861 0
NONE
Country [1] 291861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294579 0
Curtin University Human Research Ethics Committee (HREC)
Ethics committee address [1] 294579 0
Ethics committee country [1] 294579 0
Australia
Date submitted for ethics approval [1] 294579 0
14/01/2016
Approval date [1] 294579 0
16/03/2016
Ethics approval number [1] 294579 0
16th March 2016

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

Contacts
Principal investigator
Name 62566 0
A/Prof Marina Ciccarelli
Address 62566 0
Curtin University
School of OT and Social Work
Kent St, Bentley WA 6102
Country 62566 0
Australia
Phone 62566 0
+61 8 9266 3693
Fax 62566 0
Email 62566 0
[email protected]
Contact person for public queries
Name 62567 0
Thuy Tran
Address 62567 0
Hand Works Occupational Therapy
PO Box 362, Bull Creek WA 6149
Country 62567 0
Australia
Phone 62567 0
+61 431653315
Fax 62567 0
Email 62567 0
[email protected]
Contact person for scientific queries
Name 62568 0
Marina Ciccarelli
Address 62568 0
Curtin University
School of OT and Social Work
Kent St, Bentley WA 6102
Country 62568 0
Australia
Phone 62568 0
+61 8 9266 3692
Fax 62568 0
Email 62568 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
I have to discuss this with my supervisors before deciding.


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
EmbaseThe impact of a hand therapy workplace-based educational approach on the management of lateral elbow tendinopathy: A randomized controlled study.2023https://dx.doi.org/10.1016/j.jht.2021.09.004
N.B. These documents automatically identified may not have been verified by the study sponsor.