HILT vs ESWT in Supraspinatus Tendinitis

NCT07615920 | Not Yet Recruiting

• 1 other identifier: KFSIRB200-1036
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial aims to compare the effectiveness of High-Intensity Laser Therapy (HILT) and Extracorporeal Shock Wave Therapy (ESWT) in patients with supraspinatus tendinitis.

Conditions

Supraspinatus Tendinitis

Outcome Measures

Primary Outcomes (1)

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

  Pain intensity will be assessed using the Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.

  At baseline and immediately after 4 weeks of intervention

Secondary Outcomes (4)

• Shoulder Pain and Disability Measured by the Shoulder Pain and Disability Index (SPADI)

  At baseline and immediately after 4 weeks of intervention

• Upper Extremity Function Measured by the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)

  Time Frame: Baseline and immediately after 4 weeks of intervention.

• Shoulder Range of Motion Measured Using a Digital Goniometer

  Baseline and immediately after 4 weeks of intervention.

• Quality of Life Measured by the Short Form-36 Health Survey (SF-36)

  Baseline and immediately after 4 weeks of intervention.

Study Arms (3)

Group A: HILT + Conventional PT

ACTIVE COMPARATOR

Device: High-Intensity Laser Therapy; Other: Conventional Physical Therapy

Group B: ESWT + Conventional PT

ACTIVE COMPARATOR

Device: Extracorporeal Shock Wave Therapy; Other: Conventional Physical Therapy

Group C: Conventional Physical Therapy Only

ACTIVE COMPARATOR

Other: Conventional Physical Therapy

Interventions

High-Intensity Laser Therapy DEVICE

High-Intensity Laser Therapy (HILT) is an advanced electrotherapy modality that uses high-power laser energy to penetrate deep musculoskeletal tissues and stimulate biological healing processes. The device emits laser wavelengths ranging between 808-1064 nm with high peak power output, allowing deeper tissue penetration compared to conventional low-level laser therapy. HILT provides analgesic, anti-inflammatory, and biostimulatory effects through increasing local blood circulation, enhancing cellular metabolism, stimulating collagen synthesis, and promoting tissue regeneration. The treatment is non-invasive, safe, and commonly used in musculoskeletal rehabilitation, particularly for tendinopathies and chronic pain conditions.

Group A: HILT + Conventional PT

Conventional Physical Therapy OTHER

The conventional physical therapy program consisted of a combination of therapeutic exercises and physical therapy modalities aimed at reducing pain, improving shoulder range of motion, enhancing muscle strength, and restoring functional performance. The program included hot pack application, Transcutaneous Electrical Nerve Stimulation (TENS), stretching exercises, range of motion exercises, strengthening exercises for the rotator cuff and scapular stabilizers, as well as a home exercise program. Treatment sessions were conducted three times per week according to the patient's tolerance and clinical condition

Group A: HILT + Conventional PT; Group B: ESWT + Conventional PT; Group C: Conventional Physical Therapy Only

Extracorporeal Shock Wave Therapy DEVICE

Extracorporeal Shock Wave Therapy (ESWT) is a non-invasive therapeutic modality that delivers high-energy acoustic waves to injured musculoskeletal tissues. The device generates focused or radial shock waves that stimulate tissue healing, neovascularization, pain reduction, and cellular repair mechanisms. ESWT is widely used in the management of tendinopathies, calcific disorders, and chronic musculoskeletal pain. Treatment parameters typically include energy flux density, frequency, number of impulses, and treatment sessions. The therapy is considered safe and effective, with minimal side effects

Group B: ESWT + Conventional PT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants aged between 18 and 60 years.
• Clinically diagnosed supraspinatus tendinitis confirmed by ultrasound imaging.
• Shoulder pain duration greater than 3 months.
• Ability to understand and follow study instructions.
• Willingness to participate and provide informed consent.

You may not qualify if:

• Full-thickness rotator cuff tear.
• Previous shoulder surgery.
• Pregnancy.
• Neurological disorders affecting the upper limb.
• Corticosteroid injection within the previous 3 months.
• Shoulder fracture or dislocation.
• Systemic inflammatory diseases.
• Participation in other physical therapy programs during the study period

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

• Yasmin Mohamed Mahmoud

  Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy

  STUDY DIRECTOR

• Mahmoud Mohamed Ewida, PHD

  Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy

  STUDY CHAIR

• Shaimaa Ramadan Eldeab, PHD

  Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy

  STUDY DIRECTOR

• Sami ABDU Akkur, MASTER DEGREE STUDENT

  Kafrelsheikh University Faculty of Physical Therapy Department of Basic Sciences for Physical Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SAMI ABDU AKKUR, MASTER

CONTACT

+966500433558; pt.sami558@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: Princpal Investigator

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05