NCT07342426

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
7mo left

Started Jan 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jan 2026Dec 2026

Study Start

First participant enrolled

January 12, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2026

Expected
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

25 days

First QC Date

January 13, 2026

Last Update Submit

January 20, 2026

Conditions

Tennis ElbowHigh Intensity LaserLateral EpicondylitisHigh Intensity Laser Therapy

Keywords

treatment

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    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 Outcomes (2)

  • Grip strength

    From enrollment to the end of treatment at 4 weeks

  • Quality of life

    From enrollment to the end of treatment at 4 weeks

Study Arms (3)

Conrol group

PLACEBO COMPARATOR

Placebo high intensity laser therapy with Infarred ray and Transcutaneous electrical nerve stimulator therapy

Device: Infarred ray therapy systemDevice: Transcutaneous electrical nerve stimulator

Low dosage group

EXPERIMENTAL

Low dosage High intensity laser with Infarred ray and Transcutaneous electrical nerve stimulator therapy

Device: High intensity laser therapyDevice: Infarred ray therapy systemDevice: Transcutaneous electrical nerve stimulator

High dosage group

EXPERIMENTAL

High dosage High intensity laser therapy with Infarred ray and Transcutaneous electrical nerve stimulator therapy

Device: High intensity laser therapyDevice: Infarred ray therapy systemDevice: Transcutaneous electrical nerve stimulator

Interventions

Transcutaneous electrical nerve stimulatorDEVICE

Using transcutaneous electrical nerve stimulator on the affected area fior 15 minutes.

Conrol groupHigh dosage groupLow dosage group
Infarred ray therapy systemDEVICE

Using infarred ray therapy applying on affected area for 15 minutes.

Conrol groupHigh dosage groupLow dosage group
High intensity laser therapyDEVICE

Using high-intensity laser therapy applying on the affected area.

High dosage groupLow dosage group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who have received treatments other than standard treatment to the affected area within past three months
  • Patients with contraindication for rehabilitation therapy
  • Photosensitivity
  • Sensory impairment
  • Implanted cardiac pacemaker
  • Pregnancy
  • Malignancy
  • Patients with a history of surgery on the affected elbow
  • Patients with cervical radiculopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TSAI CHENG-TAO Physical Therapy Clinic

Kaohsiung City, 803, Taiwan

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Central Study Contacts

CHENG-CHANG LU

CONTACT

+886 975357331cclu0880330@gmail.com

MIN-HAO TSAI

CONTACT

+886 908011166petertsai0702@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 15, 2026

Study Start

January 12, 2026

Primary Completion

February 6, 2026

Study Completion (Estimated)

December 6, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

TW(1)