Shock Wave Therapy Versus Conventional Physical Therapy for Partial- Thickness Forearm Burn Scars

NCT07234305 | Completed

• 1 other identifier: IRB00014233-52
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Burn injuries can lead to significant physical and psychological challenges, particularly when they result in scarring. Burn scars can lead to a variety of complications that significantly impact a patient's quality of life1. Physical complications often include restricted range of motion and contractures, which can hinder mobility and daily activities, especially if the scars are located near joints2. Additionally, psychosocial effects such as anxiety, depression, and social withdrawal may arise due to the visible nature of scars and the stigma associated with them3. Functional complications can also manifest, affecting the skin's ability to regulate temperature and moisture, increasing susceptibility to infections, and causing discomfort or pain 4. In some cases, burn scars may develop into hypertrophic scars or keloids, leading to further aesthetic concerns and potential need for medical interventions5. Among the various types of burns, partial thickness burns are particularly concerning due to their potential for hypertrophic scarring and functional limitations6. Effective treatment strategies are essential to manage these scars, promote healing, and improve the quality of life for affected individuals7.

Conditions

Burn Scar; Burns

Outcome Measures

Primary Outcomes (2)

• Ultrasonography Assessment

  High-resolution ultrasound was performed using the GE Logiq P6 Pro (GE Healthcare, Solingen, Germany) machine, to measure scars during the pre-treatment, post-treatment, and follow-up periods. Scar thickness is determined at the thickest point of irregular scars

  at baseline , at 8 weeks and 8 weeks follow up

• The Vancouver Scar Scale

  The total score can range from 0 to 13, where a score of zero indicates normal skin and a score of 13 reflects the most worse scar tissue. In this study, the VSS was utilized to assess forearm scars in participants at baseline before any interventions, again after 8 weeks of treatment, and finally 8 weeks post-intervention to monitor changes over time12.

  at baseline, at 8 weeks and 8 weeks follow up

Secondary Outcomes (1)

• The Burn Specific Health Scale-Brief (BSHS-B)

  at baseline , at 8 weeks and 8 weeks follow up

Study Arms (2)

Shock wave

EXPERIMENTAL

The treatment regimen included 2000 shocks directed to the 10 cm2 scar tissue itself, 1000 shocks to the surrounding soft tissue to promote healing. Pneumatic extracorporeal shock wave therapy (ESWT) will administered using the EME Srl device (Via Degli Abeti, Pesaro- Italy) over a series of sessions

Other: Shock wave

Traditional Physical Therapy

EXPERIMENTAL

This included five minutes of passive stretching for the wrist flexors, with therapist assistance, followed by five minutes of active stretching, encouraging patients to engage in movements independently to enhance flexibility and alleviate stiffness. To rebuild strength and functionality in the forearm and hand, the regimen incorporated progressive resistance exercises such as wrist flexion and extension, performed for 20 repetitions per set, two sets per session, three times weekly, using light weights (Vinyl Dumbbell Set, Soft Grips - 2kg, progressing to 3kg, made in China). Grip strengthening exercises were also included, utilizing a guitar finger exercise grip (made in China), with 30 repetitions per set, two sets per day, three times a week.

Other: Traditional Physical Therapy

Interventions

Shock wave OTHER

The treatment regimen will include2000 shocks directed to the 10 cm2 scar tissue itself, 1000 shocks to the surrounding soft tissue to promote healing. Pneumatic extracorporeal shock wave therapy (ESWT) will administered using the EME Srl device (Via Degli Abeti, Pesaro- Italy) over a series of sessions. Patients received two sessions each week for 8 successive weeks

Shock wave

Traditional Physical Therapy OTHER

This included five minutes of passive stretching for the wrist flexors, with therapist assistance, followed by five minutes of active stretching, encouraging patients to engage in movements independently to enhance flexibility and alleviate stiffness. To rebuild strength and functionality in the forearm and hand, the regimen incorporated progressive resistance exercises such as wrist flexion and extension, performed for 20 repetitions per set, two sets per session, three times weekly, using light weights (Vinyl Dumbbell Set, Soft Grips - 2kg, progressing to 3kg, made in China). Grip strengthening exercises were also included, utilizing a guitar finger exercise grip (made in China), with 30 repetitions per set, two sets per day, three times a week.

Traditional Physical Therapy

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• adults diagnosed with partial thickness burns on the forearm,
• scars that had been present for a minimum of six months,
• participants capable of providing informed consent

You may not qualify if:

• hypersensitivity to shock wave therapy,
• active infections at the burn site,
• neurological disorders that could impact sensation,
• any contraindications that would prevent the use of ultrasonography.

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

faculty of physical therapy ,Cairo University

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: October 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 4, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)