The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns

Hand Burn Clinical Trial

Official title:

The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns : a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138355
• Other study ID #: HangangSHH-7
• Status: Completed
• Phase: N/A
• Start date: November 2, 2019
• Est. completion date: April 20, 2020

Study information

• Verified date: October 2019
• Source: Hangang Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

No study has investigated the effect of extracorporeal shock wave therapy (ESWT) on hand function and hypertrophic scar characteristics. To investigate ESWT effects on burned hands, the investigators compare the results of ESWT combined with manual therapy group to the results of matched conventional(CON) rehabilitation combined with manual therapy group.

Description:

Hands are the most frequent injury sites caused by burn, and appropriate rehabilitation is essential to ensure that good functional recovery is achieved. In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, red, inflexible and responsible functional and cosmetic impairments.

This randomized, controlled trial involved 40 patients with burns and dominant right-hand function impairment. Patients were randomized into a ESWT or a CON group. Each intervention was applied to the affected hand for 4 weeks once per week. Hand function was evaluated using the Jebsen-Taylor hand function test (JTT), grasp and pinch power test, and Michigan Hand Outcomes Questionnaire (MHQ). These assessments were evaluated pre-intervention and 4 weeks post-intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 20, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their hands

• less than 6 months since the onset of the burn injury

Exclusion Criteria:

• fourth-degree burns(involving muscles, tendons, and bone injuries)\

• musculoskeletal diseases(fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) in the burned hands

• neurological diseases(such as peripheral nerve disorders)

• preexisting physical and psychologic disability (severe aphasia and cognitive impairment that could influence the intervention)

• severe pain impeding hand rehabilitation

Related Conditions & MeSH terms

• Burns
• Hand Burn

Intervention

Other:
• Extracorporeal shock wave therapy
ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen,Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave. ESWT was performed around the primary treatment site at 100 impulses/cm2, an energy flux density(EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses were administered at 1-week intervals for 4 sessions.

Locations

Country	Name	City	State
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul	Yeong-deungpo-Dong

Sponsors (2)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital	Hallym University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Cho YS, Joo SY, Cui H, Cho SR, Yim H, Seo CH. Effect of extracorporeal shock wave therapy on scar pain in burn patients: A prospective, randomized, single-blind, placebo-controlled study. Medicine (Baltimore). 2016 Aug;95(32):e4575. doi: 10.1097/MD.000000 — View Citation

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). pii: E124. doi: 10.3390/ijms — View Citation

van der Veer WM, Bloemen MC, Ulrich MM, Molema G, van Zuijlen PP, Middelkoop E, Niessen FB. Potential cellular and molecular causes of hypertrophic scar formation. Burns. 2009 Feb;35(1):15-29. doi: 10.1016/j.burns.2008.06.020. Epub 2008 Oct 25. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thickness	scar thickness(cm)	4 weeks
Primary	melanin and erythema	measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin(AU)	4 weeks
Primary	transepithelial water loss	the degree of water evaporation	4 weeks
Primary	sebum	the severity of greese, the higher values indicating a more greese(mg/cm2)	4 weeks
Primary	elasticity	The numeric values (mm) of the skin's distortion is presented as the elasticity.	4 weeks
Secondary	grip strength	measure grip strength, the higher values indicating a more strength	4 weeks
Secondary	Jebsen-Taylor hand function test	The JTT measure the performance speed of standardized tasks. The JTT involves a series of 7 subtests. We used a scoring system (each subtest score ranged from 0 to 15, and the total score ranged from 0 to 105).	4 weeks