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The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns

Primary Purpose

Hand Burn

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy
Sponsored by
Hangang Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Burn

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hangang Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Extracorporeal shock wave therapy group

conventional manual therapy

Arm Description

. 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

grip strength
measure grip strength, the higher values indicating a more strength
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).

Full Information

First Posted
October 10, 2019
Last Updated
April 21, 2020
Sponsor
Hangang Sacred Heart Hospital
Collaborators
Hallym University
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1. Study Identification

Unique Protocol Identification Number
NCT04138355
Brief Title
The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns
Official Title
The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns : a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangang Sacred Heart Hospital
Collaborators
Hallym University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients' burn scars had re-epithelialized after aseptic care or skin graft. We included patients aged ≥18 years with a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their hands, with joint contracture(hand and wrist), having been transferred to the rehabilitation department after acute burn treatment, and less than 6 months since the onset of the burn injury. Selected patients had a history of hand surgery resulting in painful, retracting scarring on hands.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal shock wave therapy group
Arm Type
Experimental
Arm Description
. 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.
Arm Title
conventional manual therapy
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Extracorporeal shock wave therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
thickness
Description
scar thickness(cm)
Time Frame
4 weeks
Title
melanin and erythema
Description
measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin(AU)
Time Frame
4 weeks
Title
transepithelial water loss
Description
the degree of water evaporation
Time Frame
4 weeks
Title
sebum
Description
the severity of greese, the higher values indicating a more greese(mg/cm2)
Time Frame
4 weeks
Title
elasticity
Description
The numeric values (mm) of the skin's distortion is presented as the elasticity.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
grip strength
Description
measure grip strength, the higher values indicating a more strength
Time Frame
4 weeks
Title
Jebsen-Taylor hand function test
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Design Participants Intervention Outcome measures Seo, M.D
Organizational Affiliation
Hangang Scared Heart Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
State/Province
Yeong-deungpo-Dong
ZIP/Postal Code
150-719
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18952381
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.
Results Reference
result
PubMed Identifier
29301325
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):124. doi: 10.3390/ijms19010124.
Results Reference
result
PubMed Identifier
27512886
Citation
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.
Results Reference
result

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The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns

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