ESWT vs HILT in Chronic Lateral Epicondylitis

NCT07654790 | Not Yet Recruiting

• 1 other identifier: KFSIRB200-1048
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Lateral Epicondylitis

Outcome Measures

Primary Outcomes (3)

• 1. Pain intensity measured using Visual Analogue Scale (VAS).

  at baseline 4 weeks and 8 weeks

• 2. Grip strength measured using Hand Dynamometer.

  at baseline 4 weeks and 8 weeks

• 3. Upper limb disability measured using QuickDASH Questionnaire.

  at baseline 4 weeks and 8 weeks

Secondary Outcomes (4)

• 1. Pressure Pain Threshold using Algometer.

  at baseline 4 weeks and 8 weeks

• 2. Pinch Strength Measurement.

  at baseline 4 weeks and 8 weeks

• 3. Elbow Range of Motion (ROM).

  at baseline 4 weeks and 8 weeks

• 4. Oxford Elbow Score (OES).

  at baseline 4 weeks and 8 weeks

Study Arms (3)

Group A

ACTIVE COMPARATOR

Conventional Physical Therapy

Other: Conventional Physical Therapy

Group B

ACTIVE COMPARATOR

ESWT + Conventional Physical Therapy

Device: Extracorporeal shock wave therapy; Other: Conventional Physical Therapy

Group C:

ACTIVE COMPARATOR

HILT + Conventional Physical Therapy

Other: Conventional Physical Therapy; Device: High-power intinsty laser

Interventions

Extracorporeal shock wave therapy DEVICE

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).

Group B

Conventional Physical Therapy OTHER

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

Group A; Group B; Group C:

High-power intinsty laser DEVICE

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).

Group C:

Eligibility Criteria

• Age: 40 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• 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 CHAIR

• 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 DIRECTOR

Central Study Contacts

mohammed ALI alghamdi

CONTACT

=966538500550; pt.mohammedhajar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06