ISRCTN ISRCTN13618356
DOI https://doi.org/10.1186/ISRCTN13618356
Secondary identifying numbers 201505008
Submission date
13/02/2017
Registration date
14/02/2017
Last edited
15/03/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Yen-Nung Lin
Scientific

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

ORCiD logoORCID ID 0000-0002-7350-503X

Study information

Study designDouble-blind randomized cross-over trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleThe effectiveness of Kinesio taping on pain reduction in patients with chronic lateral epicondylitis: A randomized, double-blinded, cross-over study
Study objectivesThe 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(s)The Institutional Review Board of Taipei Medical University, 16/04/2016
Health condition(s) or problem(s) studiedLateral epicondylitis (tennis elbow)
InterventionParticipants 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 typeOther
Primary outcome measurePain on resisted wrist extension is measured using a numerical rating scale (NRS) before and after 15 minutes of taping in each session.
Secondary outcome measures1. 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 study start date01/02/2016
Completion date17/03/2017

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants20
Total final enrolment15
Key inclusion criteria1. Diagnosed with chronic lateral epicondylitis
2. Visiting the rehabilitation outpatient department of Wan-Fang Hospital
3. Aged 20 to 80 years
Key exclusion criteria1. 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
Date of first enrolment16/04/2016
Date of final enrolment01/03/2017

Locations

Countries of recruitment

  • Taiwan

Study participating centre

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

Sponsor information

Wan Fang Medical Center
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/058y0nn10

Funders

Funder type

Hospital/treatment centre

Wan Fang Medical Center

No information available

Results and Publications

Intention to publish date31/12/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planPlanned publication of study results in a peer reviewed journal.
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 17/03/2017 23/03/2017 No No
Results article 19/06/2018 15/03/2023 Yes No

Additional files

ISRCTN13618356_BasicResults_17Mar17.docx
Uploaded 23/03/2017

Editorial Notes

15/03/2023: Publication reference and total final enrolment added.
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.