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The Clinical Utility of Extracorporeal Shock Wave Therapy on Burns

Primary Purpose

Burn Scar

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

About this trial

This is an interventional treatment trial for Burn Scar focused on measuring burn scar, extracorporeal shock wave therapy, skin characteristics

Eligibility Criteria

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

Inclusion Criteria:

  • aged ≥18 years
  • deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn
  • less than 6 months since the onset of the burn injury

Exclusion Criteria:

  • history of cancer
  • fourth-degree burns (involving muscles, tendons, and bone injuries)
  • musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases)
  • pregnancy
  • if there was potential for additional damage to the skin due to the use of ESWT and conventional occupational therapy

Sites / Locations

  • Hangang Sacred Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Extracorporeal shock wave therapy group

sham stimulation group

Arm Description

Patients in the ESWT group were explained to select the most hypertrophic and retracting area for the treatment on dominant hand. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave (Fig. 2). 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

scar thickness
The thickness was measured with a ultrasonic wave equipment

Secondary Outcome Measures

skin darkness
the degree of pigmentation and melanin level, the higher values indicating a darker(AU)
skin reddness
the degree of erythema, the higher values indicating a redder skin(AU)
skin dryness
evaluating the degree of water evaporation(g/h/m2). the higher values indicating a skin dryness
sebum level
measurement is based on the principle of grease-spot photometry using a cassette with its special tape. A microprocessor calculates the result, which is shown on the display in mg/cm2
Elasticity
which applies negative pressure (450 mbar) on the skin. The numeric values (mm) of the skin's distortion is presented as the elasticity. Two seconds of negative pressure of 450 mbar is followed by 2 s of recess, and this consists of a complete cycle. Three measurement cycles were conducted, and the average values were obtained

Full Information

First Posted
April 2, 2020
Last Updated
June 1, 2020
Sponsor
Hangang Sacred Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04340271
Brief Title
The Clinical Utility of Extracorporeal Shock Wave Therapy on Burns
Official Title
The Clinical Utility of Extracorporeal Shock Wave Therapy on Burns of Upper Extremity : Controlled, Randomization, Double Bilind Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hangang Sacred Heart Hospital

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
In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, inflexible and responsible functional impairments. There are few studies which have investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics using objective measurements. Thus, this study aimed to ascertain the effects of ESWT on burn scars using objective measurements. This double-blinded, randomized, controlled trial involved 36 patients with burns. Patients were randomized into a ESWT (an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses) or a sham stimulation group.
Detailed Description
In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, inflexible and responsible functional impairments. There are few studies which have investigated the effect of extracorporeal shock wave therapy (ESWT) on hypertrophic scar characteristics using objective measurements. Thus, this study aimed to ascertain the effects of ESWT on burn scars using objective measurements. This double-blinded, randomized, controlled trial involved 36 patients with burns. Patients were randomized into a ESWT (an energy flux density (EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses) or a sham stimulation group. Each intervention was applied to the hypertrophic scars of upper extremities after autologous split-thickness skin grafting (STSG) using Materiderm for 4 weeks once per week. The ESWT group (n=18) received shock waves with low-energy flux density (0.05-0.30 mJ/mm2). The interval between treatments is a 1-week. The ESWT group also received standard treatment. The control group (n=18) received sham stimulation with standard treatment. The investigators compared the skin quality of the ESWT and control groups. Participants were made comfortable and acclimatized to room conditions. Room temperature was maintained at 20-25'C and relative humidity at 40-50 %. In the supine position, skin properties were measured. The thickness was measured with a ultrasonic wave equipment (128 BW1 Medison, Korea). Mexameter® (MX18, Courage-Khazaka Electronics GmbH, Germany) was used to measure melanin levels and the severity of erythema. The higher values indicating a darker and redder skin. TEWL was measured with a Tewameter® (Courage-Khazaka Electronic GmbH, Germany), which is used for evaluating water evaporation. Sebum in the scars was measured with the Sebumeter® (Courage-Khazaka Electronic GmbH, Germany). The measurement is based on the principle of grease-spot photometry using a cassette with its special tape. A microprocessor calculates the result, which is shown on the display in mg/cm2. Elasticity was measured using Cutometer SEM 580® (Courage-Khazaka Electronic GmbH, Cologne, Germany), which applies negative pressure (450 mbar) on the skin. The numeric values (mm) of the skin's distortion is presented as the elasticity. Two seconds of negative pressure of 450 mbar is followed by 2 s of recess, and this consists of a complete cycle. Three measurement cycles were conducted, and the average values were obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Scar
Keywords
burn scar, extracorporeal shock wave therapy, skin characteristics

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 split-thickness skin graft (STSG). We included patients aged ≥18 years with a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their upper extremities, having been transferred to the rehabilitation department after acute burn treatment, and less than 6 months since the onset of the burn injury.
Masking
ParticipantOutcomes Assessor
Masking Description
The patients didnot know whether it is included in the experimental group and control group Outcome measurements and data analyses were performed by a trained and blinded outcome assessor who was not involved in the intervention.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extracorporeal shock wave therapy group
Arm Type
Experimental
Arm Description
Patients in the ESWT group were explained to select the most hypertrophic and retracting area for the treatment on dominant hand. ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave (Fig. 2). 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
sham stimulation group
Arm Type
Sham Comparator
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 (Fig. 2). 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.
Intervention Type
Other
Intervention Name(s)
conventional occupational therapy
Intervention Description
Standard accupational therapy consist of range of motion exercise, strengthening exercises, and activities of daily living exercises
Primary Outcome Measure Information:
Title
scar thickness
Description
The thickness was measured with a ultrasonic wave equipment
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
skin darkness
Description
the degree of pigmentation and melanin level, the higher values indicating a darker(AU)
Time Frame
4 weeks
Title
skin reddness
Description
the degree of erythema, the higher values indicating a redder skin(AU)
Time Frame
4 weeks
Title
skin dryness
Description
evaluating the degree of water evaporation(g/h/m2). the higher values indicating a skin dryness
Time Frame
4 weeks
Title
sebum level
Description
measurement is based on the principle of grease-spot photometry using a cassette with its special tape. A microprocessor calculates the result, which is shown on the display in mg/cm2
Time Frame
4 weeks
Title
Elasticity
Description
which applies negative pressure (450 mbar) on the skin. The numeric values (mm) of the skin's distortion is presented as the elasticity. Two seconds of negative pressure of 450 mbar is followed by 2 s of recess, and this consists of a complete cycle. Three measurement cycles were conducted, and the average values were obtained
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: aged ≥18 years deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn less than 6 months since the onset of the burn injury Exclusion Criteria: history of cancer fourth-degree burns (involving muscles, tendons, and bone injuries) musculoskeletal diseases (fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) pregnancy if there was potential for additional damage to the skin due to the use of ESWT and conventional occupational therapy
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
Undecided
Citations:
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
26454624
Citation
Saggini R, Saggini A, Spagnoli AM, Dodaj I, Cigna E, Maruccia M, Soda G, Bellomo RG, Scuderi N. Extracorporeal Shock Wave Therapy: An Emerging Treatment Modality for Retracting Scars of the Hands. Ultrasound Med Biol. 2016 Jan;42(1):185-95. doi: 10.1016/j.ultrasmedbio.2015.07.028. Epub 2015 Oct 9.
Results Reference
result

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The Clinical Utility of Extracorporeal Shock Wave Therapy on Burns

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