High and Low Dose High-intensity Laser Therapy Lateral Epicondylitis

NCT07342426 — Phase 4, Recruiting, 45 participants, Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Registry	NCT07342426
Status	Recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	45 (Estimated)
Sponsor	Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Conditions	Lateral Epicondylitis, High Intensity Laser Therapy, Tennis Elbow, High Intensity Laser
Interventions	High intensity laser therapy, Infarred ray therapy system, Transcutaneous electrical nerve stimulator (Device)
Dates	start 2026-01-12, primary completion 2026-02-06 (estimated), completion 2026-12-06 (estimated), first posted 2026-01-15, last updated 2026-01-21
Locations	1 site in Taiwan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Conrol group	Placebo comparator	Device: Infarred ray therapy system; Device: Transcutaneous electrical nerve stimulator	Placebo high intensity laser therapy with Infarred ray and Transcutaneous electrical nerve stimulator therapy
Low dosage group	Experimental	Device: High intensity laser therapy; Device: Infarred ray therapy system; Device: Transcutaneous electrical nerve stimulator	Low dosage High intensity laser with Infarred ray and Transcutaneous electrical nerve stimulator therapy
High dosage group	Experimental	Device: High intensity laser therapy; Device: Infarred ray therapy system; Device: Transcutaneous electrical nerve stimulator	High dosage High intensity laser therapy with Infarred ray and Transcutaneous electrical nerve stimulator therapy

High intensity laser therapy (Device): Using high-intensity laser therapy applying on the affected area.
Infarred ray therapy system (Device): Using infarred ray therapy applying on affected area for 15 minutes.
Transcutaneous electrical nerve stimulator (Device): Using transcutaneous electrical nerve stimulator on the affected area fior 15 minutes.

+Outcome measures

Primary outcomes

Pain intensity [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.

Secondary outcomes

Grip strength [From enrollment to the end of treatment at 4 weeks]: Using dynanometer to measure grip strength
Quality of life [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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
TSAI CHENG-TAO Physical Therapy Clinic	Kaohsiung City	Taiwan	Recruiting