Lateral EpicondylitisPhase 4NCT07342426
High and Low Dose High-intensity Laser Therapy Lateral Epicondylitis
A Phase 4 study testing High intensity laser therapy, Infarred ray therapy system and Transcutaneous electrical nerve stimulator in people with Lateral Epicondylitis and High Intensity Laser Therapy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis, High Intensity Laser Therapy, Tennis Elbow
- What is being tested?
- High intensity laser therapy, Infarred ray therapy system and Transcutaneous electrical nerve stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jan 2026to 6 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with lateral epicondylitis by physician
- Disease duration of less than three months
- Adults aged above 18 years with full decision-making capacity
Who cannot join
- 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
Show all 9Show fewer
- Malignancy
- Patients with a history of surgery on the affected elbow
- Patients with cervical radiculopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
TSAI CHENG-TAO Physical Therapy Clinic
Kaohsiung City, 803
CHENG-TAO TSAI, +886 932772196, su5685@gmail.com
About this study
Official title: 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.
- Being tested
- High intensity laser therapy, Infarred ray therapy system, Transcutaneous electrical nerve stimulator
- Keywords
- treatment
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity laser therapyDevice
Using high-intensity laser therapy applying on the affected area.
Infarred ray therapy systemDevice
Using infarred ray therapy applying on affected area for 15 minutes.
Transcutaneous electrical nerve stimulatorDevice
Using transcutaneous electrical nerve stimulator on the affected area fior 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Conrol group | Placebo comparator | Placebo high intensity laser therapy with Infarred ray and Transcutaneous electrical nerve stimulator therapy Receives: Device: Infarred ray therapy system; Device: Transcutaneous electrical nerve stimulator |
| Low dosage group | Experimental | Low dosage High intensity laser with Infarred ray and Transcutaneous electrical nerve stimulator therapy Receives: Device: High intensity laser therapy; Device: Infarred ray therapy system; Device: Transcutaneous electrical nerve stimulator |
| High dosage group | Experimental | High dosage High intensity laser therapy with Infarred ray and Transcutaneous electrical nerve stimulator therapy Receives: Device: High intensity laser therapy; Device: Infarred ray therapy system; Device: Transcutaneous electrical nerve stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (2)
Grip strength
Using dynanometer to measure grip strength
Measured: From enrollment to the end of treatment at 4 weeks
Quality of life
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.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start12 Jan 2026
- Primary completion6 Feb 2026 (estimated)
- Study completion6 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342426
- Sponsor's protocol ID
- KMUHIRB-F(I)-20250361
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of High and Low Dose High-intensity Laser Therapy in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT07342426
- Acronym / sponsor ID
- KMUHIRB-F(I)-20250361
- Keywords
- treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 6 Feb 2026 (estimated)
- Study completion
- 6 Dec 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conrol group | Placebo comparator | Device: Infarred ray therapy system, Device: Transcutaneous electrical nerve stimulatorPlacebo 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 stimulatorLow 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 stimulatorHigh dosage High intensity laser therapy with Infarred ray and Transcutaneous electrical nerve stimulator therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with lateral epicondylitis by physician
- Disease duration of less than three months
- Adults aged above 18 years with full decision-making capacity
Key exclusion criteria (9 listed)
- Patients who have received treatments other than standard treatment to the affected area within past three months
- Patients with contraindication for rehabilitation therapy
- Patients with a history of surgery on the affected elbow
- Patients with cervical radiculopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity laser therapyUsing high-intensity laser therapy applying on the affected area. | Device | High dosage group, Low dosage group |
| Infarred ray therapy systemUsing infarred ray therapy applying on affected area for 15 minutes. | Device | Conrol group, High dosage group, Low dosage group |
| Transcutaneous electrical nerve stimulatorUsing transcutaneous electrical nerve stimulator on the affected area fior 15 minutes. | Device | Conrol group, High dosage group, Low dosage group |
Primary outcome
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.
2 secondary outcomes
Grip strength
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High intensity laser therapy, Infarred ray therapy system and Transcutaneous electrical nerve stimulator in people with Lateral Epicondylitis and High Intensity Laser Therapy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHENG-CHANG LU (+886 975357331, cclu0880330@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.