Condition category
Injury, Occupational Diseases, Poisoning
Date applied
13/02/2017
Date assigned
14/02/2017
Last edited
23/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic lateral epicondylitis is a long-term condition in which the outer part of the elbow becomes sore and tender. It is often referred to as “tennis elbow” as it often occurs due to strenuous overuse of the muscles and tendons of the forearm and around the elbow joint, such as by playing tennis or other racquet sports. Kinesio taping (KT) is a technique used in physiotherapy in order to help to provide support and stability to muscles and joints, without restricting a person’s range of motion. It is commonly used to treat a range of conditions and previous studies have shown that it can be very effective at aiding healing and providing support. The tape is an elastic woven-cotton strip with heat-sensitive acrylic adhesive and can stretch 120%~140% of its original length. The aim of this study is to assess the immediate effect of KT on pain reduction in patients with tennis elbow.

Who can participate?
Adult patients with tennis elbow.

What does the study involve?
Participants attend two sessions spaced three days apart in a random order. In one session, participants undergo 15 minutes of Kinesio taping. This involves having special tape called Kinesio Tex Tape applied to the arm when it is straight at the elbow and bent at the wrist to create tension. In the other session, “sham” tape is applied, which involves ordinary tape being applied while the arm is in a relaxed position. In each session, before and after the taping, participants are asked to rate their pain levels.

What are the possible benefits and risks of participating?
Participants who receive the Kinesio taping may benefit from a reduction of pain. There is a small risk of skin irritation from the tape used.

Where is the study run from?
Wan-Fang Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
February 2016 to February 2018

Who is funding the study?
Wan Fang Medical Center (Taiwan)

Who is the main contact?
Dr Yen-Nung Lin

Trial website

Contact information

Type

Scientific

Primary contact

Dr Yen-Nung Lin

ORCID ID

http://orcid.org/0000-0002-7350-503X

Contact details

No.111
Hsing-Long Road
Section 3
Taipei
116
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

201505008

Study information

Scientific title

The effectiveness of Kinesio taping on pain reduction in patients with chronic lateral epicondylitis: A randomized, double-blinded, cross-over study

Acronym

Study hypothesis

The aim of this study is to compare the effectiveness of Kinesio Taping with Sham Taping on pain reduction and other outcomes for patients with chronic lateral epicondylitis.

Ethics approval

The Institutional Review Board of Taipei Medical University, 16/04/2016

Study design

Double-blind randomized cross-over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Lateral epicondylitis (tennis elbow)

Intervention

Participants are randomised to receive two taping sessions in a random order by a coin toss. There is a three day wash-out period between the two sessions.

Session 1: Participants receive 15 minutes of Kinesio Taping (KT) using two strips of Kinesio Tex Tape. The main strip is applied along the extensor muscles with the second strip vertical to the first one on the proximal forearm while the elbow is extended and the wrist ulnar is deviated and flexed. The tape is then cut into an Y-shape and the tape head is applied (anchor) at the wrist, stretched slightly with 20% of available tension to the tails, laying down the tape ends with no tension, and applying pressure to the tape surface to initiate adhesion. The anchor of the second strip is applied with no tension below the area of adhesion, at 40% tension to each tail, laid down the ends with no tension, and with pressure applied to the tape surface to initiate adhesion.

Session 2: Participants receive 15 minutes of Sham Taping (ST) using Elastic Adhesive Tape (3M™). The procedure is similar to the KT procedure, except that the wrist is placed in a neutral rather than a flexed position when applying the tape with no tension created.

In each session, before and after the 15 minutes of tapi9ng, participants are asked to rate their pain levels using a range of questionnaires.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Pain on resisted wrist extension is measured using a numerical rating scale (NRS) before and after 15 minutes of taping in each session.

Secondary outcome measures

1. Pain at rest is measured using a numerical rating scale (NRS) before and after 15 minutes of taping in each session
2. Pain-free grip strength is measured using a dynamometer (JAMAR Plus, Patterson Medical, Canada) before and after 15 minutes of taping in each session
3. Pain threshold is measured by applying the 1-cm2 rubber probe tip of a digital algometer (Force Ten FDX Force Gage, Wagner Instruments, USA) to the most palpably tender site over the lateral epicondyle before and after 15 minutes of taping in each session

Overall trial start date

01/02/2016

Overall trial end date

17/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed with chronic lateral epicondylitis
2. Visiting the rehabilitation outpatient department of Wan-Fang Hospital
3. Aged 20 to 80 years

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Experience with KT treatment previously
2. Received a steroid injection for lateral epicondylitis within the past 3 months
3. Suspected of having elbow arthritis
4. Wounds where the tape is to be applied

Recruitment start date

16/04/2016

Recruitment end date

01/03/2017

Locations

Countries of recruitment

Taiwan

Trial participating centre

Wan-Fang Hospital
No.111, Hsing-Long Road, Section 3
Taipei
116
Taiwan

Sponsor information

Organisation

Wan Fang Medical Center

Sponsor details

Taipei Medical University
No.111
Hsing-Long Road
Section 3
Taipei
116
Taiwan

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Wan Fang Medical Center

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of study results in a peer reviewed journal.

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

31/12/2018

Participant level data

Other

Results - basic reporting

See additional file ISRCTN13618356_BasicResults_17Mar17

Publication summary

Publication citations

Additional files

Editorial Notes

23/03/2017: Results summary uploaded. 20/03/2017: The overall trial end date has been updated from 01/02/2018 to 17/03/2017 and the recruitment end date has been updated from 16/10/2017 to 01/03/2017.