This study was done to assess the effect of Botulinum toxin A on post herpetic neuralgia. Patients referred to outpatient clinics in Shiraz University of Medical Science who had post herpetic neuralgia for at least 1 month without any response to usual treatment were recruited. For each 10cm² of painful area 15IU Botulinum toxin A reconstructed with 4cc Lidocaein 5% was injected intradermaly. Before injection we used topical Lidocaein gel 2% on painful areas. Follow up was done 3 times on 2 days, 2 weeks and 1 month intervals (primary outcome). Pain in the lesions was assessed using Visual Analogue Scale. Target sample size was 15 patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812033396N1
Registration date:2010-05-19, 1389/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-19, 1389/02/29
Registrant information
Name
Parisa Taheri
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 9040
Email address
taherip@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of medical Sciences
Expected recruitment start date
2009-01-06, 1387/10/17
Expected recruitment end date
2010-02-06, 1388/11/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Botulinum toxin A on Post herpetic Neuralgia
Public title
Efficacy of Botulinum toxin A on Post herpetic Neuralgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age>18, pain>1month, sex:both
Exclusion criteria: history of botolinium toxin A injection for this pain, coagulopathy, topical infection, allergy to topical anesthetics, tumor in site of lesion, sepsis.
Age
From 18 years old to 149 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
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
Shiraz University of Medical Sciences
Street address
Zand street-Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
empty
Ethics committee reference number
88-4931
Health conditions studied
1
Description of health condition studied
Postherpetic Neuralgia
ICD-10 code
BO2.2, G53
ICD-10 code description
Postherpetic Neuralgia
Primary outcomes
1
Description
Pain
Timepoint
2 days, 2 weeks, 1 month after injection
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intradermal injection of botolinum toxin A (15 units /every 10cm² of body involved)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences Clinics
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Mohamad Hosein Dabaghmanesh
Street address
Shiraz- Zand street- Shiraz University of Medical Sciences
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 - Department of Physical Medicine and Rehabilitation
Full name of responsible person
Dr.MohamadReza Emad
Position
Associate Professor
Other areas of specialty/work
Street address
Shiraz - Zand street-University of Medical Sciences- Shahid Faghihi hospital - Department of Physical Medicine and Rehabilitation
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
emadm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.MohamadReza Emad
Position
Associate Professor
Other areas of specialty/work
Street address
Zand street- Shahid Faghihi hospital- Department of Physical medicine and Rehabilitation
City
Shiraz
Postal code
Phone
+98 71 1231 9040
Fax
Email
emadm@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
Dr.MohamedReza Emad
Position
Associate Professor
Other areas of specialty/work
Street address
Shiraz- Shiraz University of Medical Sciences- Faghihi hospital- Department of Physical medicine and Rehabilitation
City
Shiraz
Postal code
Phone
Fax
Email
emadm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)