Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000524695
Ethics application status
Approved
Date submitted
12/05/2014
Date registered
16/05/2014
Date last updated
16/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adhesive elastic therapeutic tape for treatment of upper extremity musculoskeletal disorders.
Scientific title
For adults with lateral elbow tendinosis, how effective is the use of elastic therapeutic tape compared no tape or a placebo intervention in reducing symptoms?
Secondary ID [1] 284580 0
None
Universal Trial Number (UTN)
U1111-1156-7193
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lateral elbow tendinosis (also commonly known as lateral epicondylitis) 291872 0
Condition category
Condition code
Musculoskeletal 292222 292222 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 292263 292263 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kinesiotape, a form of elastic therapeutic tape, was developed by Dr. Kenso Kase in the 1970’s and is a relatively new elastic therapeutic tape used for treating a variety of injuries in clinical practice. The principle behind kinesiotape is the theory that it supports injured muscles and joints and helps to relieve pain by lifting the skin and allowing improved blood and lymph flow. Despite its popularity and widespread clinical use, there is relatively little high quality evidence available to support the effectiveness of kinesiotape for injuries, let alone specific upper limb overuse injuries, such as lateral elbow tendinosis. It is anticipated that the results of this research study will enhance evidence for the use of kinesiotape at a broader level.

Participants in this study will be invited to undergo eight 30 minute hand therapy sessions for a period of 12 weeks. This will involve 4 weekly sessions followed by 4 fortnightly sessions. A free follow up will also be completed at 6 months which should take 30 minutes. These sessions will be administered on an individual basis by a hand therapist.

All participants in the three groups will receive the same standard treatment for tennis elbow, which includes heat, massage, education of activity modification techniques and prescription of a progressive exercise program. With regards to the treatment and placebo/sham tape group, participants will be shown how to apply the tape on the first visit and will be provided with a roll of tape for use at home. The tape can last between 4-7 days and the participant will be educated on monitoring for signs of irritation. If so, the tape should be removed immediately. The kinesiotape is applied with along the forearm and crosses over the lateral epicondyle. Two additional small strips of tape will then be applied over the lateral epicondyle in a 'star' pattern. The tension and application procedure will follow the Kinesiotape application manual. For the placebo/sham tape group, the tape will be applied in exactly the same; however, with no tension. It is anticipated that participants will use this tape for a minimum of 4 weeks full time; however, this time frame may be shorter if side effects are noted.
Intervention code [1] 289357 0
Rehabilitation
Comparator / control treatment
There will be one comparator group and one control group. The first of these groups will still receive the standard treatment for tennis elbow (including heat, massage, activity modification advice and progressive exercises) in conjunction with the use of the elastic therapeutic tape; however, the tape will be applied with no stretch (the recommended application is to use the tape with tension).

The second of these groups will receive the current treatment for lateral elbow tendinosis which includes massage, compression, activity modification advice and a graduated exercise and strengthening program.

Both the comparator and control groups will undergo the same treatment frequency as the intervention group which involves 4 weekly sessions (30 minutes each) followed by 4 fortnightly sessions (30 minutes each). This will be over a 3 month period. There will also be a free 6 month follow up session for these participants.
Control group
Active

Outcomes
Primary outcome [1] 292092 0
Reduction in pain: this will be measured using the standardised Visual Analogue Scale.
Timepoint [1] 292092 0
6 month follow up
Primary outcome [2] 292093 0
Return to function and work: this will be assessed through the Patient Rated Elbow Evaluation, the Short Form 36 and The Roles Checklist which will be completed by participants at the initial assessment, 1 month, 3 months and 6 months post treatment. These assessments look at function and work status.
Timepoint [2] 292093 0
6 month follow up
Secondary outcome [1] 308197 0
Ease of application and comfort with use of the elastic therapeutic tape: this will be assessed at 6 months post treatment with a questionnaire developed by the researcher. This will be completed only by the intervention group.
Timepoint [1] 308197 0
6 month follow up

Eligibility
Key inclusion criteria
1. Adults with a diagnosis of lateral elbow tendinosis.
2. Participants are able to understand English so that consent can be adequately given.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Their age falls outside the nominated age group.
- They have multiple diagnoses that may impact on the outcome.
- They have an intellectual disability or any other type of cognitive impairment that may impact on their ability to consent or understand treatment.
- The participant declines to take part in the study

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)
1. People who are self-referred or referred by their general practitioner or medical specialist for treatment for lateral epicondylitis will be invited to participate in the research study. As most patients book appointments over the phone, the receptionist at Toowoomba Hand Therapy (who is not directly involved in the research) will ask potential participants if they are interested in receiving the information sheet about the research study. If they are willing to consider participation in the study, the receptionist can then send the information sheet in the mail prior to their appointment.
2. After they have read the information sheet and if they are willing to participate, they will be given a consent form by the receptionist (at the time of their appointment) to be signed. This consent form contains specific details and expectations about the research project.
3. Once consent is gained, the researcher will then formally approach the participant and verbally explain the research project further and answer any questions the participant may have.
4. Participants will be free to withdraw at any time.
5. Allocation concealment wil be done by computer randomisation. This will be held within a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into the three groups using simple randomisation through statistical software. The researcher will not be blinded as to which groups participants will be allocated to.
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
For the purpose of this randomised controlled trial, it is planned to gain the largest sample size possible. This trial is part of a PhD degree through Monash; therefore, it is anticipated to gain as many participants over a one year period.

It is planned for statistical analysis to be completed using SPSS to examine correlations between the use of elastic therapeutic tape with reductions in pain, improved function and increased grip strength when compared to taping without tension or no tape. As this is part of a PhD degree through Monash University, the researcher of this study will be able to access the support of a biostatistician through Monash to assist with the statistical analysis of these results.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/05/2014
Date of last participant enrolment
Anticipated
1/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8114 0
4350 - East Toowoomba

Funding & Sponsors
Funding source category [1] 289219 0
Self funded/Unfunded
Name [1] 289219 0
No funding source
Country [1] 289219 0
Primary sponsor type
University
Name
Monash University
Address
Peninsula Campus
McMahons Road
Frankston Victoria 3199 Australia
Country
Australia
Secondary sponsor category [1] 287890 0
None
Name [1] 287890 0
Address [1] 287890 0
Country [1] 287890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290987 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 290987 0
Ethics committee country [1] 290987 0
Australia
Date submitted for ethics approval [1] 290987 0
Approval date [1] 290987 0
28/04/2014
Ethics approval number [1] 290987 0
CF14/835 - 2014000325

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

Contacts
Principal investigator
Name 48282 0
Ms Raewyn Lin Taylor
Address 48282 0
Toowoomba Hand Therapy
Entrance 3, St Vincent's Hospital
Scott Street
Toowoomba QLD 4305
Country 48282 0
Australia
Phone 48282 0
+61 7 4638 1222
Fax 48282 0
Email 48282 0
[email protected]
Contact person for public queries
Name 48283 0
Raewyn Lin Taylor
Address 48283 0
Toowoomba Hand Therapy
Entrance 3, St Vincent's Hospital
Scott Street
Toowoomba QLD 4350
Country 48283 0
Australia
Phone 48283 0
+61 7 4638 1222
Fax 48283 0
Email 48283 0
[email protected]
Contact person for scientific queries
Name 48284 0
Raewyn Lin Taylor
Address 48284 0
Toowoomba Hand Therapy
Entrance 3, St Vincent's Hospital
Scott Street
Toowoomba QLD 4350
Country 48284 0
Australia
Phone 48284 0
+61 7 4638 1222
Fax 48284 0
Email 48284 0
[email protected]

No information has been provided regarding IPD availability


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.