Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000790145
Ethics application status
Approved
Date submitted
26/04/2019
Date registered
28/05/2019
Date last updated
2/03/2021
Date data sharing statement initially provided
28/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of biomechanical tape on pain and function in people with tennis elbow
Scientific title
The effects of biomechanical tape on pain and function in individuals with lateral epicondylalgia: A single-blinded randomised crossover trial
Secondary ID [1] 295343 0
none
Universal Trial Number (UTN)
U1111-1216-3688
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Lateral epicondylalgia 308549 0
Tennis elbow 312621 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307517 307517 0 0
Physiotherapy
Musculoskeletal 307525 307525 0 0
Other muscular and skeletal disorders
Injuries and Accidents 311120 311120 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name:
Biomechanical tape

Why:
Tennis elbow is thought to be caused by excessive loading of one of the tendons at the outside of the elbow. Biomechanical tape is an elastic therapeutic tape which has four-way stretch properties that are thought to reduce the load on underlying muscles and joints. Our study will investigate whether biomechanical tape applied to the forearm muscles can reduce pain and improve function in individuals with tennis elbow.

What:
Materials:
Biomechanical tape is a safe, non-toxic, hypoallergenic, nylon- or lycra-backed elastic therapeutic tape registered with the TGA (ARTG# 220733). Please see www.gripitktape.com/products/gripit-active/new-prototype-activetape-50mm-black or www.dynamictape.info/about/

Procedures:
This randomised crossover trial will consist of one intervention: biomechanical tape, and two control/comparator treatments: 1) control tape, and 2) no tape.

The biomechanical tape intervention will be applied to the palm, back of the participants’ wrist, and forearm with the wrist in extension (held by the participant). The two end sections of the tape will act as anchors and will be applied with no stretch at either end of the tape to reduce the risk of skin irritation and ensure secure adhesion to the skin. The middle section of the tape will be stretched by 40%. To determine the required midsection length, the participant will extend the wrist and the distance from 3rd metacarpal head to forearm anchor point (2cm distal to midpoint of participant forearm) will be measured. This length will be divided by 1.4, which will allow for the tape to be stretched 40% over the 3rd metacarpal head to forearm anchor point length. In addition, a transverse piece of tape will be applied with no stretch across the dorsal wrist to prevent bowstringing.

The comparator/control treatments are described in the relevant section below.

Who provided:
The biomechanical tape will be applied by an AHPRA-registered physiotherapist who has attended a relevant biomechanical tape training session.

How:
The biomechanical tape intervention will be delivered to each participant individually in a face-to-face setting.

Where:
The study will be conducted in the exercise and sport sciences laboratories at Central Queensland University (CQU), Rockhampton North campus. There will be a plinth, chair, and table to provide a comfortable testing environment for the participant, and all equipment for application of the conditions and outcome measurement will be easily accessible.

When and how much:
Biomechanical tape will be applied on one occasion and will be worn for approximately 60-90 minutes during the session. Each participant will complete an exercise task while wearing the tape, consisting of 1) a resisted wrist pronation/supination task, 2) a resisted wrist flexion/extension task, 3) a hook-grip carrying task, 4) a gripping and reaching task, and 5) a stapling and hole-punching task. The exercise task will take approximately 20 minutes including suitable rest between exercises. The washout period (i.e. the amount of time between each session) is a minimum of 48 hours, and no more than three weeks.

Tailoring:
The biomechanical tape will be measured and cut according to the individual participant’s forearm measurements. Each participant will receive biomechanical tape (or a control condition) for the same amount of time.

Modifications:
Modifications are not required.

How well:
Measurement of adherence is not applicable as participants are only wearing the biomechanical tape in the laboratory, thus will be monitored by the assessor for the duration of assessment.
Intervention code [1] 301666 0
Treatment: Devices
Intervention code [2] 301921 0
Rehabilitation
Comparator / control treatment
There are two comparator/control treatments in this trial, each will be included as a separate data collection session in the crossover trial:

1) No Tape: The participant will sit comfortably for the same period of time that is required to apply the biomechanical tape intervention and the control tape treatment.

2) Control Tape: Application of the control tape treatment will follow the same process as the biomechanical tape intervention, except the tape will be measured from the mid palm anchor point to the forearm point halfway point with the wrist held in flexion, and will be applied in a flexed position with no stretch. A transverse piece of tape will be applied across the dorsal wrist with no stretch to ensure a similar surface area is covered.
Control group
Active

Outcomes
Primary outcome [1] 306490 0
Pain-free grip strength in 90 degrees of shoulder flexion, full elbow extension, and forearm pronation. Three trials of each position will be measured, in Newtons, using a hand-held grip dynamometer.
Timepoint [1] 306490 0
1) Before application of the condition (baseline)
2) 5 minutes after application of the condition (immediately post-application; primary endpoint)
3) 40-60 minutes after application of the condition (immediately post-exercise)
Primary outcome [2] 307374 0
Pain-free grip strength in 0 degrees of shoulder flexion, 90 degrees of elbow flexion, and forearm pronation. Three trials of each position will be measured, in Newtons, using a hand-held grip dynamometer.
Timepoint [2] 307374 0
1) Before application of the condition (baseline)
2) 5 minutes after application of the condition (immediately post-application; primary endpoint)
3) 40-60 minutes after application of the condition (immediately post-exercise)
Primary outcome [3] 320062 0
Pressure pain threshold at the affected lateral epicondyle. Three trials will be measured, in kilopascals, using a hand-held pressure algometer using a standardised procedure.
Timepoint [3] 320062 0
1) Before application of the condition (baseline)
2) 5 minutes after application of the condition (immediately post-application; primary endpoint)
3) 40-60 minutes after application of the condition (immediately post-exercise)
Secondary outcome [1] 348667 0
Pressure pain threshold at 1) the unaffected lateral epicondyle and 2) at a distant anatomic site (such as the patellar tendon, or tibia). Three trials of each location will be measured, in kilopascals, using a hand-held pressure algometer using a standardised procedure.
Timepoint [1] 348667 0
1) Before application of the condition (baseline)
2) 5 minutes after application of the condition (immediately post-application)
3) 40-60 minutes after application of the condition (immediately post-exercise)
Secondary outcome [2] 351687 0
Wrist angle during grip strength measures. The angle, in degrees, will be will be measured during all grip strength trials, using surface-mounted sensors.
Timepoint [2] 351687 0
1) Before application of the condition (baseline)
2) 5 minutes after application of the condition (immediately post-application)
3) 40-60 minutes after application of the condition (immediately post-exercise)
Secondary outcome [3] 351693 0
Muscle activity of key forearm extensor and flexor muscles during grip strength measures. The muscle activity will be recorded using surface-mounted wireless electromyography mini-sensors attached over the site of the forearm muscles.
Timepoint [3] 351693 0
1) Before application of the condition (baseline)
2) 5 minutes after application of the condition (immediately post-application)
3) 40-60 minutes after application of the condition (immediately post-exercise)
Secondary outcome [4] 351696 0
Maximum grip strength in two positions as described for pain-free grip strength above. Three trials of each position will be measured, in Newtons, using a hand-held grip dynamometer.
Timepoint [4] 351696 0
1) Before application of the condition (baseline)
2) 5 minutes after application of the condition (immediately post-application)
3) 40-60 minutes after application of the condition (immediately post-exercise)
Secondary outcome [5] 370405 0
Patient-rated Global Rating of Change during the session will be measured on a 7-point scale ranging from “very much worse” to “very much better”.
Timepoint [5] 370405 0
40-60 minutes after application of the condition (immediately post-exercise and following all other outcome measures)
Secondary outcome [6] 370406 0
Protocol Perception Question - The participant will be asked whether they think the tape applied as per the manufacturer’s protocol was applied as the first or second taping condition. This is to determine if the participant remained blinded to the condition in which the tape was applied as per the manufacturer’s protocol.
Timepoint [6] 370406 0
1) At the end of the last condition

Eligibility
Key inclusion criteria
1) Are aged 18 years or over,
2) Have a current episode of unilateral (one-sided) pain on the outside of elbow of a minimum six weeks’ duration,
3) Have reduced pain-free grip strength (i.e. 60% or less of the unaffected side),
4) Test positive for at least two out of three physical pain provocation tests 1) pain on palpation of the lateral epicondyle, 2) pain during a resisted wrist extension movement, 3) pain during third finger extension movement.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Have a disease or illness that may influence pain or strength scores (e.g. cancer, fibromyalgia, Parkinson’s disease, multiple sclerosis),
2) Have a cardiac pacemaker,
3) Are pregnant or breastfeeding,
4) Have had a significant arm injury in the past five years (e.g. large fractures or burns) causing ongoing restriction of movement or muscle weakness,
5) Have had treatment from a health professional for their elbow in the past 3 months,
6) Have had a corticosteroid injection for their elbow pain in the last 6 months,
7) Have had spinal, arm, or leg pain (i.e. other than their affected elbow) in the past 3 months, that has required treatment from a health professional or prevented participation in work or recreational activities,
8) Have a severe allergy to tape or silver (for EMG sensors),
9) Are unable to understanding written or spoken English.

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)
Enrolment procedure: Participants will be enrolled in a staged screening process:
1) Potential participants will complete an online screening survey to determine preliminary eligibility.
2) Potential participants will be telephoned to determine if they are suitable to attend a physical examination.
3) The physical examination will involve questions about the participants' pain and three tests to confirm a diagnosis of tennis elbow.
4) Participants who meet the eligibility criteria and who wish to participate will sign an informed consent form.

Allocation concealement procedure: The participant will be allocated an order of conditions via numbered, opaque, sealed envelopes, prepared by an independent research assistant. The outcome assessor will not be aware of the order of conditions during the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomised sequence of conditions will be generated by simple randomisation using a randomisation table created by computer software (Microsoft Excel, 2016). This will be performed by a research assistant who will allocate condition sequences into opaque numbered envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size is based a 3 x 2 (condition x time) Analysis of Variance for the primary outcome of pain free grip strength. A sample size calculation was performed using GLIMMPSE Guided Study Design (version 2.2.8). Based on change in pain-free grip strength mean and SD data from a previous taping study, an error probability of 0.05, and a moderate correlation among repeated measures (r = 0.8 between conditions and 0.9 within session), it was determined that 27 participants are required to detect a condition x time interaction with a power of 0.8. To account for dropouts, an additional 10% will be recruited giving a sample size target of 30.
Repeated measure Analysis of Variance will be used to examine differences in VNRS scores between data collection sessions. Repeated measure Analysis of Variance will also be used to examine differences in dependent variables (i.e. PPT, pain-free and maximum grip strength, wrist extension angle, muscle activity during gripping) between conditions and across within-session time points. Significant main effects and interactions will be further examined using Tukey’s HSD post hoc test. Statistical significance will be set at an alpha level of 0.05. Results will be reported using mean differences and 95% confidence intervals, along with Cohen’s d effect sizes.
To examine the influence of psychological factors (i.e. kinesiophobia, self-efficacy, and pain catastrophisation) on changes in primary outcome measures (i.e. pain-free grip strength and pressure pain threshold at the lateral epicondyle), a hierarchical multiple regression analysis will be performed. Each regression model will be presented in a table and the results will be reported as a proportion of variance with the statistical significance set at an alpha level of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/06/2019
Actual
26/06/2019
Date of last participant enrolment
Anticipated
7/10/2020
Actual
10/12/2020
Date of last data collection
Anticipated
31/10/2020
Actual
29/01/2021
Sample size
Target
27
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 23158 0
4701 - Central Queensland University
Recruitment postcode(s) [2] 23159 0
4700 - Rockhampton
Recruitment postcode(s) [3] 23160 0
4702 - Central Queensland
Recruitment postcode(s) [4] 23161 0
4703 - Yeppoon
Recruitment postcode(s) [5] 23164 0
4704 - Yaamba

Funding & Sponsors
Funding source category [1] 299937 0
University
Name [1] 299937 0
Central Queensland University
Country [1] 299937 0
Australia
Funding source category [2] 299961 0
Other Collaborative groups
Name [2] 299961 0
Sports Medicine Australia Research Foundation
Country [2] 299961 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
Central Queensland University
Bruce Highway
Rockhampton North
4701 QLD Australia
Country
Australia
Secondary sponsor category [1] 299340 0
None
Name [1] 299340 0
Address [1] 299340 0
Country [1] 299340 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300802 0
Central Queensland University Human Research Ethics Council, NHMRC Registration code EC00158
Ethics committee address [1] 300802 0
Ethics committee country [1] 300802 0
Australia
Date submitted for ethics approval [1] 300802 0
11/09/2018
Approval date [1] 300802 0
03/10/2018
Ethics approval number [1] 300802 0
0000021221

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

Contacts
Principal investigator
Name 84862 0
Dr Crystal Kean
Address 84862 0
Building 81 1/1.09
Central Queensland University
Bruce Highway, Rockhampton, 4701, QLD, Australia
Country 84862 0
Australia
Phone 84862 0
+61 07 49232283
Fax 84862 0
Email 84862 0
[email protected]
Contact person for public queries
Name 84863 0
Crystal Kean
Address 84863 0
Building 81 1/1.09
Central Queensland University
Bruce Highway, Rockhampton, 4701, QLD, Australia
Country 84863 0
Australia
Phone 84863 0
+61 07 49232283
Fax 84863 0
Email 84863 0
[email protected]
Contact person for scientific queries
Name 84864 0
Ms. Caitlin Hill
Address 84864 0
Building 81 1/1.16
Central Queensland University
Bruce Highway, Rockhampton, 4701, QLD, Australia
Country 84864 0
Australia
Phone 84864 0
+61 07 49232283
Fax 84864 0
Email 84864 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
The project data management plan states that data will not be made available for publication.


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
EmbaseEffects of multidirectional elastic tape on forearm muscle activity and wrist extension during submaximal gripping in individuals with lateral elbow tendinopathy: A randomised crossover trial.2022https://dx.doi.org/10.1016/j.clinbiomech.2022.105810
N.B. These documents automatically identified may not have been verified by the study sponsor.