Charts of 200 registered patients with electrical burns in Shiraz burn center will be reviewed. We will includ 18 to 50 years old patients experiencing electrical injury 15 days to 3 months prior to the study. Those patients who don’t have the exclusion criteria will fill in the informed consent form. Bone mineral density (BMD), T scores, and Z scores at lumbar vertebrae and left femur of the participants will be measured . Sympathetic skin response (SSR) of the subjects will also be recorded from both soles and both palms. Then the patients will be divided into two groups using block randomization. And the case group will recieve 80 mg propranolol / d
ay for 12 weeks and then gradually tapered to discontinue in 1 week. And the control group will receive placebo for the same duration. SSR recording and BMD measurement will be repeated for both groups the day after the last dose and 9 months later With the methods described for these measurements at the beginning of the study. The gathered data will be analyzed statistically using SPSS 16.0. Independent sample t-test will be used for comparing means between the two groups. And the correlation between quantitative variables will be tested with Pearson correlation coefficient. P < 0.05 will be considered statistically significan
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111930974N1
Registration date:2017-01-18, 1395/10/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-18, 1395/10/29
Registrant information
Name
Zohreh Eshghi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 781 5296
Email address
eshghi_z@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigation of the effect of propranolol on sympathetic skin response and bone mass density of burn patients
Public title
investigation of the effect of propranolol on sympathetic skin response and bone mass density of burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
We will include 18 to 50 years old patients experiencing electrical injury 15 days to 3 months prior to the study. Exclusion criteria are as follows: positive history of joint or bone disease; neuropathy (central or peripheral); diabetes mellitus or consumption of any drug affecting the autonomic nervous system; any cast; skin lesion, skin graft, or scar at the sites of SSR recording or stimulus (palms, soles, wrists, or ankles) that make technical problems for SSR recording; contraindications of propranolol administration such as bronchial asthma, pronounced bradycardia, manifest heart failure, second and third degree heart block, hypersensitivity to propranolol. Any patient with evidence of peripheral neuropathy on 4 limb electrophysiologic study (done at the beginning of the study after filling in the written informed consent).
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
Approval date
2016-11-02, 1395/08/12
Ethics committee reference number
IR.SUMS.MED.1395.54
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T20-32
ICD-10 code description
Burns and corrosions
Primary outcomes
1
Description
Bone mass desitometery
Timepoint
Before study and 3 months, 9 months after study
Method of measurement
Bone mass densitometery
2
Description
Sympathetic skin response
Timepoint
Before study and 3 months, 9 months after study
Method of measurement
SSR
Secondary outcomes
1
Description
Decreased blood pressure
Timepoint
Before and every 2 weeks after study
Method of measurement
Mesurment of blood pressure
Intervention groups
1
Description
The control group will receive placebo for 12 weeks
Category
Placebo
2
Description
The intervention group will recieve 80 mg propranolol / day for 12 weeks and then gradually tapered to discontinue in 1 week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Medicine and Rehabilotation Depatment, Shiraz University of Medical Sciences
Full name of responsible person
Eshghi Zohreh
Street address
Faghihi hosptal
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ms. Akbarnezhad
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Eshghi
Position
MD
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitatin Depatment, Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 3231 9040
Fax
Email
eshghi_z@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Physical Medicine and Rehabilitation Department, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sharareh Roshanzamir
Position
MD, assistance professor
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Department, Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 3231 9040
Fax
Email
sharareh.roshanzamir@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zohre Eshghi
Position
MD
Other areas of specialty/work
Street address
Physical Medicine and Reahabilitation Depatment, Faghihi hospital
City
Shiraz
Postal code
Phone
+98 71 3231 9040
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)