The effect of intradermal Dysport injections on painful diabetic polyneuropathy
Design
In group D1, 150 units BTX- A solved in 2 ml saline normal 0.9%, injected in 20 points of right foot of patients intradermally and in left foot in 20 points saline normal 0.9% are injected intradermally .In group D2 150 unites of BTX- A solved in 4 ml saline normal 0.9% for each foot 75 units botulinum toxin A in 20 points of soles of each patient injected intradermally. In group N, in 20 points of sole of each patient with 1 cm from each other and in each point 10 units of insulin syringe of saline normal 0.9% is injected.
Settings and conduct
This study was a prospective, randomized study based on three months of follow-up exerted between May 2019 and September 2019.The patients were enrolled from Tehran, Iran in the clinic of pain of Imam Hossein hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diabetic type I or II; bilateral symmetric distal polyneuropathy based on the Douleur Neuropathique 4 (DN4) questionnaire and Nerve conduction velocity (NCV); aged between 40 and 70 years old
Exclusion criteria: Patients aged more than 70 years; local infection in lower limbs; lumbar radiculopathy; neurologic or mental deficit; allergy to the botulinum toxin or used NSAIDs or other medications to alleviate the neuropathic pain; history of alcohol or opium consume; renal disease; muscular weakness or atrophy of lower limb; history of myasthenia gravis; use of aminoglycosides; breastfeeding mothers
Intervention groups
All patients were divided randomly into three groups: one group received botulinum toxin A in one foot and saline normal 0.9% in another foot (group D1),another group received botulinium toxin A in both feet (group D2).The other group received saline normal 0.09% in both feet (group N).
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130518013364N8
Registration date:2019-11-29, 1398/09/08
Registration timing:retrospective
Last update:2019-11-29, 1398/09/08
Update count:0
Registration date
2019-11-29, 1398/09/08
Registrant information
Name
Mehrdad Taheri
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 7840
Email address
m.taheri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
2019-05-10, 1398/02/20
Actual recruitment end date
2019-09-16, 1398/06/25
Trial completion date
2019-11-11, 1398/08/20
Scientific title
The effect of intradermal Dysport injections on painful diabetic polyneuropathy
Public title
The effect of intradermal Dysport injections on painful diabetic polyneuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
diabetic type I or II
bilateral symmetric distal polyneuropathy based on the Douleur Neuropathique 4 (DN4) questionnaire and Nerve conduction velocity (NCV)
aged between 40 and 70 years old
Exclusion criteria:
local infection in lower limbs
lumbar radiculopathy
neurologic or mental deficit
allergy to the botulinum toxin or used NSAIDs or other medications to alleviate the neuropathic pain
history of alcohol or opium consume
renal disease
muscular weakness or atrophy of lower limb
history of myasthenia gravis
use of aminoglycosides
breastfeeding mothers
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
141
Actual sample size reached:
141
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to one of three groups using the simple random sampling with substitution with the help of a random numbers table (Kendall & Smith table).
Blinding (investigator's opinion)
Double blinded
Blinding description
The physician who injects the drug solutions and the one who evaluates the patients in follow-up visits, are different and are blind to the subject. Patients are not aware of injectable drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2019-04-30, 1398/02/10
Ethics committee reference number
IR.SBMU.MSP.REC.1398.028
Health conditions studied
1
Description of health condition studied
Diabetic polyneuropathy
ICD-10 code
E10.42
ICD-10 code description
Type 1 diabetes mellitus with diabetic polyneuropathy
2
Description of health condition studied
Diabetic polyneuropathy
ICD-10 code
E11.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy
Primary outcomes
1
Description
Pain
Timepoint
4 weeks
Method of measurement
VAS
2
Description
Neuropathy Pain Scale (NPS)
Timepoint
4 weeks
Method of measurement
Scores are based on patients responses to questions (NPS)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: group D1, 150 units BTX- A solved in 2 ml saline normal 0.9%, injected in 20 points of right foot of patients intradermally and in left foot in 20 points saline normal 0.9% are injected intradermally
Category
Rehabilitation
2
Description
Second intervention group: group D2, 150 unites of BTX- A solved in 4 ml saline normal 0.9% for each foot 75 units botulinum toxin A in 20 points of soles of each patient injected intradermally.
Category
Rehabilitation
3
Description
Control group: group N, in 20 points of sole of each patient with 1 cm from each other and in each point 10 units of insulin syringe of saline normal 0.9% is injected.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospitalʼs pain clinic
Full name of responsible person
Mehrdad Taheri
Street address
Shahid Madani street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziai
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
0098 73430000
Email
m.taheri@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the initial implications
When the data will become available and for how long
Since 2020
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Mehrdad Taheri
taheri.1352@yahoo.com
What processes are involved for a request to access data/document