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 measure
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 (if study stopped)
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
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
Basic results (scientific)
See additional file ISRCTN13618356_BasicResults_17Mar17
Publication list
Publication citations
Additional files
- ISRCTN13618356_BasicResults_17Mar17.docx Uploaded 23/03/2017