- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06382805
Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy in Lateral Epicondylitis
April 23, 2024 updated by: abuzer akbaş, Hasan Kalyoncu University
Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy on Pain, Grip Strength and Functional Level in Patients With Lateral Epicondylitis: a Randomized Controlled Study.
Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension.
The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method.
The purpose of this study is to compare the effectiveness of kinesio tape and high intensity laser in the treatment of lateral epicondylitis.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension.
It is usually a non-inflammatory tendinopathy of the extensor carpi radialis and extensor digitorum comminis.
Calcific tendinitis and/or partial tears in the wrist extensor muscles may accompany this condition.
It is most common between the ages of 30-60 and its prevalence has been reported as 1-1.7%
Although the underlying cause is mostly unknown, activities that involve excessive use of wrist extensors and supinators are thought to be the most important cause of lateral epicondylitis .The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method.
Non-surgical treatment approaches such as patient education physiotherapy applications, manual therapy, laser therapy, splinting, taping, exercises, massage and local injection, as well as oral or topical nonsteroidal anti-inflammatory drugs are frequently applied.
Kinesio tape, which is frequently used in musculoskeletal system injuries, is flexible, mimics skin and has a water-resistant structure.
Kinesio tape creates a pumping system by pulling the skin up in the area where it is applied, thus increasing the skin space, increasing blood and lymph circulation, and creating analgesia and proprioceptive sensory input by reducing the pressure on pain receptors .
There are scientific studies showing that kinesio tape application reduces pain and increases functionality and grip strength in patients with lateral apicondylitis.
It is stated that high-intensity laser treatment can quickly create photochemical and photothermic effects in deep tissue.
For this reason, collagen production in tendons is stimulated and can increase blood flow, vascular permeability and cell metabolism.
As a result of all these events, tissue healing begins and painful stimuli disappear.
It has been shown that high-intensity laser reduces pain and increases functionality and grip strength in patients with lateral epicondylitis.
In the literature review, no randomized controlled studies were found comparing high-intensity laser and kinesio tape applications in patients with lateral epicondylitis
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: abuzer akbaş
- Phone Number: +90 5326442366
- Email: akbas.abuzer@gmail.com
Study Contact Backup
- Name: murat ali çınar
- Phone Number: 2105 0(342) 211 8080
- Email: muratali.cinar@hku.edu.tr
Study Locations
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-
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Gaziantep, Turkey, 27000
- Hasan Kalyoncu University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients over 18 years of age.
- Those who have pain with palpation applied to the lateral epicondyle
- Patients with pain in resisted extension of the wrist and/or middle finger
- Pain during static stretching applied to the wrist while the elbow is extended
- The complaints must last at least three months
- Not having received treatment in the last three months.
Exclusion Criteria:
- Pregnant and breastfeeding women
- History of fracture or surgery in the elbow area
- Detection of calcific tendinitis on plain radiograph of the elbow
- History of neurological disease
- History of osteoporosis, malignancy, hemophilia
- Rheumatoid arthritis and other inflammatory diseases
- Cognitive problem
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program.
|
The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program.
Cold-pack will be applied for 15 minutes.
Continuous ultrasound will be applied on lateral epicondylitis with a 5-cm ultrasound head at a dose of 1.5W/cm2 for 5 minutes and a frequency of 1-MHZ.
TENS application will be performed with the BTL 4000 combination device.
TENS will be applied for 20 minutes, increasing the intensity of the current until the patient feels it.
The treatment program will last for a total of two weeks, 5 days a week.
|
Active Comparator: kinesiotaping group
Kinesio tape application will be applied to the kinesio tape group in addition to physiotherapy. The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program. |
The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program.
Cold-pack will be applied for 15 minutes.
Continuous ultrasound will be applied on lateral epicondylitis with a 5-cm ultrasound head at a dose of 1.5W/cm2 for 5 minutes and a frequency of 1-MHZ.
TENS application will be performed with the BTL 4000 combination device.
TENS will be applied for 20 minutes, increasing the intensity of the current until the patient feels it.
The treatment program will last for a total of two weeks, 5 days a week.
The longitudinal muscle technique will be applied from the origin to the insertion of the forearm extensor muscles by a researcher with a Kinesio tape application certificate.
In addition, transverse kinesio tape will be applied on the elbow using the fascia correction technique.
The treatment program will last for a total of two weeks, 5 days a week.
|
Active Comparator: high intensity laser therapy group
High-intensity laser application will be applied to the high-intensity laser group in addition to physiotherapy.
The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program.
|
The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program.
Cold-pack will be applied for 15 minutes.
Continuous ultrasound will be applied on lateral epicondylitis with a 5-cm ultrasound head at a dose of 1.5W/cm2 for 5 minutes and a frequency of 1-MHZ.
TENS application will be performed with the BTL 4000 combination device.
TENS will be applied for 20 minutes, increasing the intensity of the current until the patient feels it.
The treatment program will last for a total of two weeks, 5 days a week.
High intensity laser applications will be performed using the BTL-6000 (BTL Company, UK) device.
The first 5 sessions will be applied to the painful area for 75 seconds at a dose of 4W 6 J/cm2 (analgesic effect) by making circular movements from the center to the outside.
The remaining 5 sessions will be applied to the painful area with linear movements for 12 minutes and 30 seconds at a dose of 6W 100-150 J/cm2 (biostimulation effect).
The treatment program will last for a total of two weeks, 5 days a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Measurement
Time Frame: Pain will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
|
Patients' lateral epicondylitis pain intensity will be evaluated with a visual analog scale (VAS).
On the visual analog scale, the left end of a 10 cm straight line represents no pain, and the right end represents excruciating pain.
The patient will be asked to mark the pain he feels on the VAS scale during the test, and then this value will be measured and recorded with the help of a ruler.
|
Pain will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
|
Hand grip strength
Time Frame: Hand grip strength will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
|
A standard hand dynamometer (Jamar® Plus + Digital Hand Dynamometer from Patterson Medical, Sammons Preston, Bolingbrook, USA) will be used to measure grip strength.
The Jamar dynamometer has high reliability and validity; therefore the device has been considered the gold standard for assessing grip strength.
Grip strength evaluation will be performed with patients in a sitting position from a chair.
During the test, patients will be asked to position their elbows in 90° flexion and their forearms and wrists in neutral position.
The test will be repeated 3 times with one minute intervals and the average of the obtained values will be recorded.
|
Hand grip strength will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
|
Patient-Rated Tennis Elbow Evaluation
Time Frame: Patient-Rated Tennis Elbow Evaluation will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
|
Functional levels of the patients will be assessed with a Patient-Rated Tennis Elbow Evaluation questionnaire.
The questionnaire consists of a total of 15 questions evaluating the functional level of patients with lateral epicondylitis in the last week.
5 questions evaluate pain and the other 10 questions evaluate functional level in various tasks.
The score for each question is between 0 (best) and 10 (worst).
The best score that can be obtained in the section that evaluates functionality is 0, while the worst score is 100.
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Patient-Rated Tennis Elbow Evaluation will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Sensitivity Measurement
Time Frame: Pain Sensitivity Measurement will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
|
Pain sensitivity will be measured with a pressure pain meter (JTECH Medical, Midvale, UT, USA).
Measurements will be made by the same researcher under the same conditions.
The researcher will press a 1 cm2 probe perpendicularly to the affected lateral epicondyle and the first point where the patient feels pain will be recorded.
Measurements will be repeated 3 times and the average of these values will be taken.
|
Pain Sensitivity Measurement will be evaluated before treatment, immediately after treatment and 6 weeks after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: abuzer akbas, hasan kalyoncu university faculty of health science
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
November 15, 2024
Study Registration Dates
First Submitted
April 20, 2024
First Submitted That Met QC Criteria
April 20, 2024
First Posted (Actual)
April 24, 2024
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HasanKU_FTR_AA_02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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