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

NCT06438224 | Recruiting DMC

• 1 other identifier: HangangSHH-18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Joint contractures and nerve injuries are common after hand burns. Extracorporeal shock wave therapy (ESWT) is effective not only for the regeneration of various tissues, including scar tissues, but also for reducing pain and pruritus in patients with burns. Researchers have attempted to explore the effects of ESWT on hand dysfunction caused by nerve injury following burns. The investigators planned to evaluate the effects of ESWT (compared to sham stimulation) on hands with nerve injury and hypertrophic scars and thereby on hand function. The ESWT parameters were as follows: energy flux density, 0.05-0.30 mJ/mm2; frequency, 4 Hz; 1000 to 2000 impulses per treatment; and 12 treatments, one/week for 12 weeks. Outcome measures were as follows: 10-point visual analog scale for pain, Jebsen-Taylor hand function test, grip strength, Purdue Pegboard test, ultrasound measurement of scar thickness, and skin characteristics before and immediately after 12 weeks of treatment.

Conditions

Hand Injuries; Extracorporeal Shock Wave Therapy; Burns

Keywords

Extracorporeal shock wave therapy; hypertrophic scar; burns; hand function; nerve injury

Outcome Measures

Primary Outcomes (1)

• 10-point visual analog scale (VAS)

  self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain

  12 weeks

Secondary Outcomes (7)

• the total active motion (TAM) scoring system

  12 weeks

• Jebsen-Taylor hand function test (JTT)

  12 weeks

• Grip and pinch strengths

  12 weeks

• Scar thickness

  12 weeks

• erythema

  12 weeks

Study Arms (2)

Extracorporeal shock wave therapy (ESWT)

EXPERIMENTAL

Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals.

Other: Extracorporeal shock wave therapy (ESWT)

sham group

SHAM COMPARATOR

the sham group was treated using an adapter that had the same shape but did not emit any energy

Other: sham stimulation

Interventions

Extracorporeal shock wave therapy (ESWT) OTHER

Those in the ESWT group were asked to select the most hypertrophic and retracting scars for treatment. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals.

Extracorporeal shock wave therapy (ESWT)

sham stimulation OTHER

the sham group was treated using an adapter that had the same shape but did not emit any energy

sham group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• had sustained a deep partial-thickness (second-degree) or a full-thickness (third-degree) burn in the right dominant hand, which had been treated with a split-thickness skin graft (STSG) after the thermal injury
• nerve injury to the hand was confirmed by electromyography
• \< 6 months prior to the enrollment

You may not qualify if:

• musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) of the hands
• acute infection
• malignant tumors
• coagulopathy
• pregnancy
• potential for additional skin damage if exposed to ESWT and conventional occupational therapy.

Sponsors & Collaborators

• Hangang Sacred Heart Hospital: lead

Study Sites (1)

Hangang sacred heart hodpital

Seoul, 07247, South Korea

RECRUITING

Related Publications (2)

• Thiele S, Thiele R, Gerdesmeyer L. Lateral epicondylitis: This is still a main indication for extracorporeal shockwave therapy. Int J Surg. 2015 Dec;24(Pt B):165-70. doi: 10.1016/j.ijsu.2015.09.034. Epub 2015 Oct 9.

  PMID: 26455532 RESULT

• Cui HS, Hong AR, Kim JB, Yu JH, Cho YS, Joo SY, Seo CH. Extracorporeal Shock Wave Therapy Alters the Expression of Fibrosis-Related Molecules in Fibroblast Derived from Human Hypertrophic Scar. Int J Mol Sci. 2018 Jan 2;19(1):124. doi: 10.3390/ijms19010124.

  PMID: 29301325 RESULT

MeSH Terms

Conditions

Hand Injuries; Burns; Cicatrix, Hypertrophic

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• SO YOUNG JOO

  handgang sacred heart hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Rakyum

CONTACT

82-2-2639-5900; sung6652@hallym.or.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland), with an electromagnetic cylindrical coil source used to focus the shock wave. ESWT was performed around the primary treatment site, at an intensity of 100 impulses/cm2, an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, and frequency of 4 Hz. Regarding the volume of treatment, 1000-3000 impulses were administered per session for 12 sessions held at 1-week intervals. As in previous studies, the sham group was treated using an adapter that had the same shape but did not emit any energy

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: May 31, 2024
• Study Start: January 1, 2023
• Primary Completion: July 10, 2024
• Study Completion: August 20, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)