Chronic Lateral EpicondylitisESWT vs HILTNCT07654790
ESWT vs HILT in Chronic Lateral Epicondylitis
A study testing Extracorporeal shock wave therapy, Conventional Physical Therapy and High-power intinsty laser in people with Chronic Lateral Epicondylitis, run by Kafrelsheikh University.
Trial summary
This randomized controlled trial aims to compare the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) and High-Intensity Laser Therapy (HILT) in patients with chronic lateral epicondylitis. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Chronic Lateral Epicondylitis
- What is being tested?
- Extracorporeal shock wave therapy, Conventional Physical Therapy and High-power intinsty laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Apr 2027
- Phase
- Interventional
- 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 40 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Age 40-50 years.
- Clinically diagnosed chronic lateral epicondylitis.
- Symptoms lasting more than 3 months.
- Positive clinical provocation tests.
- Localized tenderness over the lateral epicondyle.
Who cannot join
- • Previous elbow surgery.
- Corticosteroid injection within the last 6 months.
- Cervical radiculopathy.
- Peripheral nerve entrapment.
- Rheumatologic or systemic inflammatory disorders.
- Elbow fracture.
- Severe elbow instability
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Shockwave Therapy Versus High-Power Laser Therapy in the Management of Chronic Lateral Epicondylitis: A Double-Blind Randomized Controlled Trial
This randomized controlled trial aims to compare the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) and High-Intensity Laser Therapy (HILT) in patients with chronic lateral epicondylitis.
Read the detailed description
Participants will be randomly assigned into three groups receiving either conventional physiotherapy alone, ESWT plus conventional physiotherapy, or HILT plus conventional physiotherapy. Clinical assessments will be performed before and after treatment
- Conditions
- Chronic Lateral Epicondylitis
- Being tested
- Extracorporeal shock wave therapy, Conventional Physical Therapy, High-power intinsty laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal shock wave therapyDevice
The Group will receive ESWT plus conventional physiotherapy treatment program. Regarding ESWT protocol, the group will receive 1,000, 1,500, and 2,000 pulses during the first, second, and third through fifth treatments, respectively (pressure, 2.5 bar; frequency, 8 Hz; energy density, 0.4 mJ/mm2). The patients received 5 ESWT treatments once per week. The treatments were performed using a Rosetta ESWT (CR Technology, Korea). Ultrasound gel was applied between the apparatus head and skin. The procedure was performed in the area with the most intense pain. Treatment was administered at the anterior aspect of the LE and three points around it at a radius of 1.5-2 cm. The treatment time did not exceed 10 minutes. During the treatments, the patients did not receive any drugs (Lizis, 2015).
Conventional Physical TherapyOther
The conventional program will include TENS for twenty minutes in elbow region; the use of pulse ultrasound with duty cycle 80% on the lateral epicondyle for five minutes with an intensity of 0.8 W per every cm'; the use of ice for ten minutes; training for correcting the daily activities to minimize pressure on the elbow (preferentially, holding, lifting and pressing the objects will be asked to be carried out in supination); and, stretch and strain wrist muscle strengthening exercises (Fekri et al., 2019). The exercise therapy method involved six elbow joint exercises. They are a total of six exercises (Fig. 2) for patients with tennis elbow. Each exercise will be performed three times a day, with each session involving five repetitions of the movement, over four weeks, gradually increasing weight until the movement is effective but below the pain threshold. Painful movements will be avoided, and exercises causing pain or discomfort will be discontinued following consultation from a p
High-power intinsty laserDevice
The Group will receive HILT plus conventional physiotherapy treatment program. High-power laser used in the present research paper was MLS Laser, Model M6 (ASA), that will be included in class four lasers device, with maximum 25-Watt power, average power of 3.3 Watts, wavelength of 808 nm in a continuous state. The target region diameter in this device will be 5 cm and the energy used for treating the patients will be 272.4 Jules, and the energy density will be 13.89 Jules per cm' with a 700-hertz frequency for a period of three minutes on the lateral epicondyle and the origin of the wrist's extensor muscles (Fekri et al., 2019).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Conventional Physical Therapy Receives: Other: Conventional Physical Therapy |
| Group B | Active comparator | ESWT + Conventional Physical Therapy Receives: Device: Extracorporeal shock wave therapy; Other: Conventional Physical Therapy |
| Group C: | Active comparator | HILT + Conventional Physical Therapy Receives: Other: Conventional Physical Therapy; Device: High-power intinsty laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Pain intensity measured using Visual Analogue Scale (VAS).
Measured: at baseline 4 weeks and 8 weeks
2. Grip strength measured using Hand Dynamometer.
Measured: at baseline 4 weeks and 8 weeks
3. Upper limb disability measured using QuickDASH Questionnaire.
Measured: at baseline 4 weeks and 8 weeks
Secondary outcomes (4)
1. Pressure Pain Threshold using Algometer.
Measured: at baseline 4 weeks and 8 weeks
2. Pinch Strength Measurement.
Measured: at baseline 4 weeks and 8 weeks
3. Elbow Range of Motion (ROM).
Measured: at baseline 4 weeks and 8 weeks
4. Oxford Elbow Score (OES).
Measured: at baseline 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lateral EpicondylitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali Saleh Alghamdi, Kafrelsheikh University
- Investigators
- MAHMOUD MOHAMMED EWIDA, PHD, Study chair, Professor of Basic Sciences for Physical Therapy Department of Basic Sciences for Physical Therapy Faculty of Physical Therapy Kafrelsheikh UniversityMOHAMMED FATHY ABDEL-GALIL, Study director, Lecturer of Basic Sciences for Physical Therapy Department of Basic Sciences for Physical Therapy Faculty of Physical Therapy Kafrelsheikh UniversityHOSSAM MOHAMMED GAD, PHD, Study director, Professor of Orthopaedic Surgery Department of Orthopaedic Surgery Faculty of medicine Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654790
- Sponsor's protocol ID
- KFSIRB200-1048
- Acronym
- ESWT vs HILT
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Shockwave Therapy Versus High-Power Laser Therapy in the Management of Chronic Lateral Epicondylitis: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07654790
- Acronym / sponsor ID
- ESWT vs HILT / KFSIRB200-1048
- Conditions
- Chronic Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 17 Jun 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.
This randomized controlled trial aims to compare the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) and High-Intensity Laser Therapy (HILT) in patients with chronic lateral epicondylitis.
Detailed description
Participants will be randomly assigned into three groups receiving either conventional physiotherapy alone, ESWT plus conventional physiotherapy, or HILT plus conventional physiotherapy. Clinical assessments will be performed before and after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Conventional Physical TherapyConventional Physical Therapy |
| Group B | Active comparator | Device: Extracorporeal shock wave therapy, Other: Conventional Physical TherapyESWT + Conventional Physical Therapy |
| Group C: | Active comparator | Other: Conventional Physical Therapy, Device: High-power intinsty laserHILT + Conventional Physical Therapy |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Age 40-50 years.
Key exclusion criteria (7 listed)
- • Previous elbow surgery.
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 |
|---|---|---|
| Extracorporeal shock wave therapyThe Group will receive ESWT plus conventional physiotherapy treatment program. Regarding ESWT protocol, the group will receive 1,000, 1,500, and 2,000 pulses during the first, second, and third through fifth treatments, respectively (pressure, 2.5 bar; frequency, 8 Hz; energy density, 0.4 mJ/mm2). The patients received 5 ESWT treatments once per week. The treatments were performed using a Rosetta ESWT (CR Technology, Korea). Ultrasound gel was applied between the apparatus head and skin. The procedure was performed in the area with the most intense pain. Treatment was administered at the anterior aspect of the LE and three points around it at a radius of 1.5-2 cm. The treatment time did not exceed 10 minutes. During the treatments, the patients did not receive any drugs (Lizis, 2015). | Device | Group B |
| Conventional Physical TherapyThe conventional program will include TENS for twenty minutes in elbow region; the use of pulse ultrasound with duty cycle 80% on the lateral epicondyle for five minutes with an intensity of 0.8 W per every cm'; the use of ice for ten minutes; training for correcting the daily activities to minimize pressure on the elbow (preferentially, holding, lifting and pressing the objects will be asked to be carried out in supination); and, stretch and strain wrist muscle strengthening exercises (Fekri et al., 2019). The exercise therapy method involved six elbow joint exercises. They are a total of six exercises (Fig. 2) for patients with tennis elbow. Each exercise will be performed three times a day, with each session involving five repetitions of the movement, over four weeks, gradually increasing weight until the movement is effective but below the pain threshold. Painful movements will be avoided, and exercises causing pain or discomfort will be discontinued following consultation from a p | Other | Group A, Group B, Group C: |
| High-power intinsty laserThe Group will receive HILT plus conventional physiotherapy treatment program. High-power laser used in the present research paper was MLS Laser, Model M6 (ASA), that will be included in class four lasers device, with maximum 25-Watt power, average power of 3.3 Watts, wavelength of 808 nm in a continuous state. The target region diameter in this device will be 5 cm and the energy used for treating the patients will be 272.4 Jules, and the energy density will be 13.89 Jules per cm' with a 700-hertz frequency for a period of three minutes on the lateral epicondyle and the origin of the wrist's extensor muscles (Fekri et al., 2019). | Device | Group C: |
Primary outcome
1. Pain intensity measured using Visual Analogue Scale (VAS).
Time frame: at baseline 4 weeks and 8 weeks
2. Grip strength measured using Hand Dynamometer.
Time frame: at baseline 4 weeks and 8 weeks
3. Upper limb disability measured using QuickDASH Questionnaire.
Time frame: at baseline 4 weeks and 8 weeks
4 secondary outcomes
1. Pressure Pain Threshold using Algometer.
Time frame: at baseline 4 weeks and 8 weeks
2. Pinch Strength Measurement.
Time frame: at baseline 4 weeks and 8 weeks
3. Elbow Range of Motion (ROM).
Time frame: at baseline 4 weeks and 8 weeks
4. Oxford Elbow Score (OES).
Time frame: at baseline 4 weeks and 8 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 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
MAHMOUD MOHAMMED EWIDA, PHD study chair
Professor of Basic Sciences for Physical Therapy Department of Basic Sciences for Physical Therapy Faculty of Physical Therapy Kafrelsheikh University
MOHAMMED FATHY ABDEL-GALIL study director
Lecturer of Basic Sciences for Physical Therapy Department of Basic Sciences for Physical Therapy Faculty of Physical Therapy Kafrelsheikh University
HOSSAM MOHAMMED GAD, PHD study director
Professor of Orthopaedic Surgery Department of Orthopaedic Surgery Faculty of medicine Kafrelsheikh University
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal shock wave therapy, Conventional Physical Therapy and High-power intinsty laser in people with Chronic Lateral Epicondylitis, run by Kafrelsheikh University.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 mohammed ALI alghamdi (=966538500550, pt.mohammedhajar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Pain intensity measured using Visual Analogue Scale (VAS). (time frame: at baseline 4 weeks and 8 weeks). The study lists 3 primary outcomes in all. 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 17 Jun 2026.