High and Low Dose High-intensity Laser Therapy Lateral Epicondylitis

January 20, 2026 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

Comparison of the Effects of High and Low Dose High-intensity Laser Therapy in Patients With Lateral Epicondylitis

High-intensity laser therapy has gained increasing attention in recent years as a therapeutic modality. It is a non-invasive treatment that can reduce pain, increase local blood circulation, and promote tissue repair. The higher energy output of high-intensity laser therapy also have deeper tissue penetration. Several studies have investigated the effects of high-intensity laser therapy on lateral epicondylitis, and the existing literature indicates that, compared with other treatment modalities, high-intensity laser therapy is more effective in improving pain and quality of life in patients with lateral epicondylitis.

However, the dosage, duration, and treatment frequency applied in previous studies vary considerably. The therapeutic effects of high-intensity laser therapy may therefore be influenced by treatment dosage. Consequently, the purpose of this study is to compare the effects of two different dosages of high-intensity laser therapy on patients with lateral epicondylitis.

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
45

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.
  • Phase 4

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

  • Taiwan
      • Kaohsiung City, Taiwan, 803
        • Recruiting
        • TSAI CHENG-TAO Physical Therapy Clinic
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients diagnosed with lateral epicondylitis by physician
  2. Disease duration of less than three months
  3. Adults aged above 18 years with full decision-making capacity

Exclusion Criteria:

  1. Patients who have received treatments other than standard treatment to the affected area within past three months

  2. Patients with contraindication for rehabilitation therapy

    1. Photosensitivity
    2. Sensory impairment
    3. Implanted cardiac pacemaker
    4. Pregnancy
    5. Malignancy
  3. Patients with a history of surgery on the affected elbow
  4. Patients with cervical radiculopathy

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: Double

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.
Placebo Comparator: Conrol group
Placebo high intensity laser therapy with Infarred ray and Transcutaneous electrical nerve stimulator therapy
Device: Infarred ray therapy system
Using infarred ray therapy applying on affected area for 15 minutes.
Device: Transcutaneous electrical nerve stimulator
Using transcutaneous electrical nerve stimulator on the affected area fior 15 minutes.
Experimental: Low dosage group
Low dosage High intensity laser with Infarred ray and Transcutaneous electrical nerve stimulator therapy
Device: Infarred ray therapy system
Using infarred ray therapy applying on affected area for 15 minutes.
Device: Transcutaneous electrical nerve stimulator
Using transcutaneous electrical nerve stimulator on the affected area fior 15 minutes.
Device: High intensity laser therapy
Using high-intensity laser therapy applying on the affected area.
Experimental: High dosage group
High dosage High intensity laser therapy with Infarred ray and Transcutaneous electrical nerve stimulator therapy
Device: Infarred ray therapy system
Using infarred ray therapy applying on affected area for 15 minutes.
Device: Transcutaneous electrical nerve stimulator
Using transcutaneous electrical nerve stimulator on the affected area fior 15 minutes.
Device: High intensity laser therapy
Using high-intensity laser therapy applying on the affected area.

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 intensity
Time Frame: From enrollment to the end of treatment at 4 weeks
Using visual analog scale to measure pain intensity. Score from 0 to 10. Score 0 means no pain and score 10 indicates highest pain.
From enrollment to the end of treatment at 4 weeks

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
Grip strength
Time Frame: From enrollment to the end of treatment at 4 weeks
Using dynanometer to measure grip strength
From enrollment to the end of treatment at 4 weeks
Quality of life
Time Frame: From enrollment to the end of treatment at 4 weeks
Using Quick disabilities of the Arm, Shoulder, and hand scale (also known as Quick DASH) to measure quality of life of participants. Scale contains 11 questions. Each question scored from 1 to 5, higher score indicates higher degree of disability.
From enrollment to the end of treatment at 4 weeks

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.
Kaohsiung Medical University Chung-Ho Memorial Hospital

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.
January 12, 2026

Primary Completion (Estimated)

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.
February 6, 2026

Study Completion (Estimated)

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.
December 6, 2026

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).
January 13, 2026

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.
January 13, 2026

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.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

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.
January 21, 2026

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.
January 20, 2026

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.
January 1, 2026

More Information

Terms related to this study

Keywords

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.
  • KMUHIRB-F(I)-20250361

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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