Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06438224

Clinical Utility of Extracorporeal Shock Wave Therapy in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns

Led by Hangang Sacred Heart Hospital · Updated on 2024-08-20

120

Participants Needed

1

Research Sites

5 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of extracorporeal shock wave therapy (ESWT) on hand function in patients who have nerve injuries and hypertrophic scars caused by burns. Hand burns can lead to joint stiffness and muscle weakness that affect quality of life. This study compares ESWT to a sham treatment to explore its impact on nerve injury and scar tissue regeneration. Participants receive either ESWT or a sham treatment over 12 weeks, with one session per week. The ESWT is delivered using a specialized device targeting the most affected scar areas with 1000 to 3000 impulses per session at specific energy and frequency settings. The sham group receives a similar device that does not emit energy. During the study, researchers assess pain using a visual analog scale, hand function through several tests, grip strength, scar thickness, skin redness, water loss through the skin, and pigmentation. These measurements are taken before treatment and immediately after 12 weeks. The study involves randomized group assignment and double-blinding to ensure unbiased results.

CONDITIONS

Brief Title

Clinical Utility of ESWT in Restoring Hand Function of Patients With Nerve Injury and Hypertrophic Scars Due to Burns

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Sustained a deep partial-thickness or full-thickness burn on the right dominant hand
  • Burn treated with a split-thickness skin graft after injury
  • Nerve injury to the hand confirmed by electromyography
  • Burn injury occurred less than 6 months before enrollment
Not Eligible

You will not qualify if you...

  • Musculoskeletal diseases of the hands such as fractures, amputations, rheumatoid arthritis, or degenerative joint diseases
  • Acute infection
  • Malignant tumors
  • Coagulopathy
  • Pregnancy
  • Risk of additional skin damage from ESWT and conventional occupational therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants receive extracorporeal shock wave therapy (ESWT) or sham stimulation targeting hypertrophic scars on the hand once a week.

12 weekly visits (in-person)

Trial Site Locations

Total: 1 location

1

Hangang sacred heart hodpital

Seoul, South Korea, 07247

Actively Recruiting

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Research Team

S

Sung Rakyum

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Extracorporeal Shock Wave Therapy Alters the Expression of Fibrosis-Related Molecules in Fibroblast Derived from Human Hypertrophic Scar.

Hui Song Cui, A Ram Hong, June-Bum Kim...

https://pubmed.ncbi.nlm.nih.gov/29301325