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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06438224
• Other study ID #: HangangSHH-18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: May 2024
• Source: Hangang Sacred Heart Hospital
• Contact: Sung Rakyum
• Phone: 82-2-2639-5900
• Email: sung6652[@]hallym.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. We 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.

Description:

Burns that occur in the hand cause early joint range-of-motion (ROM) limitations and hand muscle weakness that significantly affect quality of life. Hand burns, though restricted to a small total body surface area (TBSA), can have significant functional consequences. 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. We 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 20, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• = 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Burns
• Cicatrix, Hypertrophic
• Hand Injuries
• Hypertrophy
• Shock
• Wounds and Injuries

Intervention

Other:
• Extracorporeal shock wave therapy (ESWT)
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.
• sham stimulation
the sham group was treated using an adapter that had the same shape but did not emit any energy

Locations

Country	Name	City	State
Korea, Republic of	Hangang sacred heart hodpital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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/ijms1901012 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10-point visual analog scale (VAS)	self-reported pain severity, ratings ranging from 0 (no pain) to 10 (unbearable pain	12 weeks
Secondary	the total active motion (TAM) scoring system	range of motion measurement	12 weeks
Secondary	Jebsen-Taylor hand function test (JTT)	The JTT consists of seven subtests, each scored on a 0-15-point scale, with higher scores indicating better hand function	12 weeks
Secondary	Grip and pinch strengths	quantified using a hand-held dynamometer (Lafayette Instrument, USA), with higher socres indicating more stronger	12 weeks
Secondary	Scar thickness	quantified using ultrasonography (128 BW1 US system, Medison, Korea)	12 weeks
Secondary	erythema and pigementation	Mexameter®(MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure the melanin levels and the severity of erythema. Higher values indicated darker and redder skin.	12 weeks
Secondary	Trans-epidermal water loss (TEWL)	measured using a Tewameter® (Courage-Khazaka Electronic GmbH, Germany) to evaluate water evaporation.	12 weeks