ANZCTR - Registration

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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

Date results information initially provided

17/12/2019

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]

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

Condition category

Condition code

Musculoskeletal

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]

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]

Durable Return to Work

Timepoint [1]

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]

Claims Cost

Timepoint [2]

Primary outcome [3]

Claim Duration

Timepoint [3]

Secondary outcome [1]

Pain

Timepoint [1]

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]

Pain-free Grip Strength

Timepoint [2]

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]

Function

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

Kent St, Bentley WA 6102

Country [1]

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]

None

Name [1]

NONE

Address [1]

NONE

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee (HREC)

Ethics committee address [1]

Curtin University
Kent St, Bentley WA 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/01/2016

Approval date [1]

16/03/2016

Ethics approval number [1]

16th March 2016

Summary

Brief summary

Background: Lateral Epicondylalgia (LE), also known as tennis elbow, is one of the most prevalent musculoskeletal disorders among the working population. Despite the numerous treatment methods available to manage the symptoms of this common condition, no sound clinical evidence is available to suggest long term relief and functional restoration for injured workers with LE. Workplace-based rehabilitation has been recognised in recent years to provide many benefits in the return to work process for injured workers for other health conditions. However, no studies have investigated this type of intervention for the management of LE. Consideration of the injured workers workplace as part of the rehabilitation program may not only possibly improve long term outcomes for workers with LE, but may also provide further information on preventative strategies to avoid the occurrence of LE.
Purpose: The primary purpose of this study is to investigate the impact of adding a workplace-based hand therapy intervention to the usual clinic-based approach on the return to work outcomes of injured workers with LE, compared to the usual clinic-based hand therapy intervention only.
Method: Mixed methodologies will be used in this study. A scoping review will be conducted to identify the effectiveness of current common conservative treatment methods for the management of LE and determine the impact of workplace-based interventions for the general management of injured workers in the return to work process. Surveys will be distributed to identify the current practice trends of medical practitioners and hand therapists in the management LE. A randomised controlled trial (RCT) will be conducted to identify (i) any differences in primary outcomes of claims costs and claims duration on the return to work status of injured workers who receive usual care vs. usual care + workplace-based intervention and (ii) any differences in secondary outcomes of pain, grip strength and function of injured workers who receive usual care vs. usual care + workplace based intervention. Finally, focus groups will be used to identify the lived experience of these injured workers with LE within the workers’ compensation system.
Expected Results: The results from this study will inform the key stakeholders in the workers’ compensation system (employers, medical practitioners, insurance case managers, vocational rehabilitation providers, and hand therapists), to establish an evidence-based approach for the management of injured workers with LE.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Marina Ciccarelli

Address

Curtin University
School of OT and Social Work
Kent St, Bentley WA 6102

Country

Australia

Phone

+61 8 9266 3693

Fax

[email protected]

Contact person for public queries

Name

Ms Thuy Tran

Address

Hand Works Occupational Therapy
PO Box 362, Bull Creek WA 6149

Country

Australia

Phone

+61 431653315

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Marina Ciccarelli

Address

Curtin University
School of OT and Social Work
Kent St, Bentley WA 6102

Country

Australia

Phone

+61 8 9266 3692

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	The impact of a hand therapy workplace-based educational approach on the management of lateral elbow tendinopathy: A randomized controlled study.	2023	https://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.

Trial Review

Documents added manually

Documents added automatically