The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns

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

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.

Study Overview

• Status: Completed
• Conditions: Hand Burn
• Intervention / Treatment: Other: Extracorporeal shock wave therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yeong-deungpo-Dong
    • Seoul, Yeong-deungpo-Dong, Korea, Republic of, 150-719
      • Hangang Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extracorporeal shock wave therapy group; . 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.	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.
No Intervention: conventional manual therapy; the same shock wave equipment used in the experimental group was used with a sham adapter that had the same shape but emitted no energy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thickness	scar thickness(cm)	4 weeks
melanin and erythema	measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin(AU)	4 weeks
transepithelial water loss	the degree of water evaporation	4 weeks
sebum	the severity of greese, the higher values indicating a more greese(mg/cm2)	4 weeks
elasticity	The numeric values (mm) of the skin's distortion is presented as the elasticity.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
grip strength	measure grip strength, the higher values indicating a more strength	4 weeks
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

Collaborators and Investigators

• Sponsor: Hangang Sacred Heart Hospital
• Collaborators: Hallym University
• Investigators: Study Director: Study Design Participants Intervention Outcome measures Seo, M.D, Hangang Scared Heart Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.0000000000004575.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: HangangSHH-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No