Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy in Lateral Epicondylitis

November 26, 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Adıyaman, Turkey, 02000
        • Adıyaman Training and Research Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group
The physiotherapy program will consist of cold-pack, US, transcutaneous electrical stimulation (TENS) and home exercise program.
Other: Physiotherapy 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.
Other: Physiotherapy 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.
Other: Kinesio Tape
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.
Other: Physiotherapy 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.
Other: High Intensity Laser therapy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Patient-Rated Tennis Elbow Evaluation will be evaluated before treatment, immediately after treatment and 6 weeks after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasan Kalyoncu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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