- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07654790
ESWT vs HILT in Chronic Lateral Epicondylitis (ESWT vs HILT)
June 12, 2026 updated by: Mohammed Ali Saleh Alghamdi, Kafrelsheikh University
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Interventional
Enrollment (Estimated)
72
Phase
- Not Applicable
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
- Name: mohammed ALI alghamdi
- Phone Number: =966538500550
- Email: pt.mohammedhajar@gmail.com
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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• 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.
Exclusion Criteria:
• 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
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
Conventional Physical Therapy
|
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
|
|
Active Comparator: Group B
ESWT + Conventional Physical Therapy
|
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
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).
|
|
Active Comparator: Group C:
HILT + Conventional Physical Therapy
|
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
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
1. Pain intensity measured using Visual Analogue Scale (VAS).
Time Frame: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
|
2. Grip strength measured using Hand Dynamometer.
Time Frame: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
|
3. Upper limb disability measured using QuickDASH Questionnaire.
Time Frame: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
1. Pressure Pain Threshold using Algometer.
Time Frame: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
|
2. Pinch Strength Measurement.
Time Frame: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
|
3. Elbow Range of Motion (ROM).
Time Frame: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
|
4. Oxford Elbow Score (OES).
Time Frame: at baseline 4 weeks and 8 weeks
|
at baseline 4 weeks and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: MAHMOUD MOHAMMED EWIDA, PHD, Professor of Basic Sciences for Physical Therapy Department of Basic Sciences for Physical Therapy Faculty of Physical Therapy Kafrelsheikh University
- Study Director: MOHAMMED FATHY ABDEL-GALIL, Lecturer of Basic Sciences for Physical Therapy Department of Basic Sciences for Physical Therapy Faculty of Physical Therapy Kafrelsheikh University
- Study Director: HOSSAM MOHAMMED GAD, PHD, Professor of Orthopaedic Surgery Department of Orthopaedic Surgery Faculty of medicine Kafrelsheikh University
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 (Estimated)
August 1, 2026
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
April 1, 2027
Study Registration Dates
First Submitted
June 12, 2026
First Submitted That Met QC Criteria
June 12, 2026
First Posted (Actual)
June 17, 2026
Study Record Updates
Last Update Posted (Actual)
June 17, 2026
Last Update Submitted That Met QC Criteria
June 12, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-1048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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