Hypertrophic scars is one of the common complications after burn which would cause performance and appearance limitations. The existing surgical and conservative treatments are not always satisfying. Shock wave is a non-aggressive modality which has proven to have positive effects on scars and wound healing in a few conducted studies. The present study will evaluate the effect of shock wave on improving limb scars.
This study is a non-randomized, uncontrolled, single-center stage 2 clinical trial.
Participants are patients with an age of 18 years old or more with limb scars. Patients who has coagulopathy or heart pacemaker, pregnant women and patients with a history of chemotherapy and radiotherapy will be excluded from the study.
17 patients will be treated with chock wave for 6 sessions during 6 weeks. This study will be conducted in 2016 on patients who will refer to the burn unit of Imam Musa Kazem hospital for treatment. Before, right after, one month and three months after the intervention, pain and itching will be evaluated using VAS method and the appearance of scar will be evaluated using VSS method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012132091N1
Registration date:2017-02-06, 1395/11/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-06, 1395/11/18
Registrant information
Name
Mahsa Mazaheri
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 2875
Email address
m.mazaheri@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-04-18, 1395/01/30
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of treatment with extracorporeal shock wave to improve the burn scar of limbs in burn patients
Public title
Shock wave for treating burn scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being older than 18 years with limb burn scar caused by fire
Exclusion criteria: having face, genitalia, thorax and neck scar; being pregnant for women; having coagulopathy and heart pacemaker; Undergoing chemotherapy and radiotherapy; having mental and physical disability; Not cooperating or not referring to continue the treatment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
17
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar Jarib Boulevard
City
Isfahan
Postal code
Approval date
2016-04-13, 1395/01/25
Ethics committee reference number
IR.MUI.REC.1395.3.273
Health conditions studied
1
Description of health condition studied
burn scar
ICD-10 code
T20
ICD-10 code description
Burn and corrosion of head and neck
2
Description of health condition studied
burn scar
ICD-10 code
T21
ICD-10 code description
Burn and corrosion of trunk
3
Description of health condition studied
burn scar
ICD-10 code
T22
ICD-10 code description
Burn and corrosion of shoulder and upper limb, except wrist and hand
4
Description of health condition studied
burn scar
ICD-10 code
T23
ICD-10 code description
Burn and corrosion of wrist and hand
5
Description of health condition studied
burn scar
ICD-10 code
T24
ICD-10 code description
Burn and corrosion of hip and lower limb, except ankle and foot
6
Description of health condition studied
burn scar
ICD-10 code
T25
ICD-10 code description
Burn and corrosion of ankle and foot
Primary outcomes
1
Description
burn scar
Timepoint
before the intervention, right after the intervention, 1 month after the end of the intervention, 3 months after the end of the intervention
Method of measurement
Visual Analogue Scale (VAS), Vancouver Scar Scale (VSS), Photographing the scar
Secondary outcomes
1
Description
burning pain
Timepoint
before the intervention, right after the intervention, 1 month after the end of the intervention, 3 months after the end of the intervention
Method of measurement
Viasual Analogue Scale (VAS)
2
Description
Scar Appearance
Timepoint
before the intervention, right after the intervention, 1 month after the end of the intervention, 3 months after the end of the intervention
Method of measurement
Vancouver Scar Scale (VSS)- photography
3
Description
Itching
Timepoint
before the intervention, right after the intervention, 1 month after the end of the intervention, 3 months after the end of the intervention
Method of measurement
Viasual Analogue Scale (VAS)
Intervention groups
1
Description
Treatment using STORZ MEDICAL AG device made in Switzerland by protocol 2 (Energy: 0.1 j/mm2, 100 impulses per cm2 and frequency of 4 Hz using focused probe) for 6 sessions, one session per week
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospitl, Department of physical medicine
Full name of responsible person
Dr. Parisa Taheri
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mansour Siavash
Street address
Isfahan University of Medical Sciences, Department of internal diseases
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of medical Sciences
Full name of responsible person
Mahsa Mazaheri
Position
Resdident of Physical medicine and Rehabilitation
Other areas of specialty/work
Street address
darvazeh shiraz square-hezar jarib street-pezeshkan buildings-5th block- 6th floor- unit B
City
Isfahan
Postal code
Phone
+98 31 3668 2875
Fax
Email
M.mazaheri@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Parisa Taheri
Position
Specialist
Other areas of specialty/work
Street address
Al-Zahra hospital, physical medicine department
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
Prs_taheri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University
Full name of responsible person
Zahra Saghaei
Position
Electronics Engineer
Other areas of specialty/work
Street address
Isfahan University, Darvazeh Shiraz
City
Isfahan
Postal code
Phone
+98 31 3226 3193
Fax
Email
zsaghaei@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)