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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

January 12, 2026

Primary Completion (Estimated)

February 6, 2026

Study Completion (Estimated)

December 6, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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