Determining the effect of botulinum toxin A injection in improving pain and quality of life in patients with diabetic neuropathy
Design
This clinical efficacy study has a control group in a Double blind, randomized on 30 patients.
Settings and conduct
By using ready-filled syringes and sealed envelopes, the patients, the injecting person, the outcome assessor, the data analyst and the researcher were blinded to the treatment groups and the patients were randomly divided into 2 groups of 15 people (botulinum toxin injection and placebo or normal Saline) will be divided. The place of study will be Mahdieh Hospital in Tehran
Participants/Inclusion and exclusion criteria
People with definitive diagnosis of diabetes with symptoms of diabetic neuropathy, diabetic neuropathy in the plantar area of both feet confirmed by NCV. Suffering from diabetes for at least three years.
Consistency of the patient's medication for diabetic neuropathy for at least one month before entering the study .Exclusion criteria:g Having an underlying disease involving the peripheral nerves that causes symptoms similar to diabetic neuropathy in the plantar area.
Change in the patient's medication for diabetic neuropathy during at least one month before entering the study
History of myasthenia gravis, Allergy to botulinum toxin
suffering from kidney disorder,Having a history of alcohol consumption
Opioid addiction, Presence of pain with a typical dermatomal pattern caused by radiculopathy
Intervention groups
15 patients with diabetic neuropathy who receive 240 units of botulinum toxin A drug, 15 patients receive placebo with the same amount and method.ا
Main outcome variables
Improving pain and quality of life and sleep in patients with diabetic neuropathy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240116060710N1
Registration date:2024-02-02, 1402/11/13
Registration timing:prospective
Last update:2024-02-02, 1402/11/13
Update count:0
Registration date
2024-02-02, 1402/11/13
Registrant information
Name
yasaman malekzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 9373
Email address
yasimalekztaheri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-04-21, 1403/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Botulinum toxin type A Masport 500 injection on improving pain and quality of life in patients with diabetic neuropathy.
Public title
Evaluation the effect of Botulinium toxin injection on improving symptoms in patients with diabetic neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diabetic neuropathy in the plantar area of both feet confirmed by NCV.
diabetes at least for three years
Consistency of the patient's medication for diabetic neuropathy for at least one month before entering the study
Filling out a personal consent form to enter the study
Exclusion criteria:
Having an underlying disease involving the peripheral nerves that causes symptoms similar to diabetic neuropathy in the plantar area.
Change in the patient's medication for diabetic neuropathy during at least one month before entering the study
History of myasthenia gravis
Allergy to botulinum toxin
kidney dysfunction
Having a history of alcohol consumption
Opioid addiction
Presence of pain with a typical dermatomal pattern caused by radiculopathy
Lack of patient consent to participate in the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Dividing patients into case and control groups based on the block randomization method for all patients in the case and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
In this clinical trial study, 30 patients with diabetic neuropathy confirmed by electrodiagnostic study and with symptoms of diabetic neuropathy will be included in the study. For the random allocation of people in the study groups (intervention group and control group) using the random allocation or block method randomization will be used. In this method, blocks of 6 (including three people in the intervention group and 3 people in the control group) will be used with a ratio of 1:1. Random Allocation software will be used to generate random sequences.
Random allocation concealment method will be used, in this way that the random sequences created in this method, which are identified by the letters a (intervention group) and b (control group), will be recorded on cards and these cards will be sealed inside the envelope. will be placed in order. In order to preserve the created sequence, numbering will also be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder, then according to the order of arrival of the eligible participants, the envelopes will be opened and The assigned group of that participant will be determined
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Shahid Beheshti univercity of medical sciences
Street address
Shahid Beheshti university of medical sciennce ,Yaman Street ,Chamran highway ,Velenjak Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-02-20, 1402/12/01
Ethics committee reference number
ir.SBMU.MSP.REC.1402.496
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain and quality of life and sleep quality of patients
Timepoint
at the begining of the study and in 1-4-8-12 week after intervention
Method of measurement
Evaluation of changes in scores of VAS, PSQI, SF-36 questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
After covering the perianal bilateral surface of the foot and the front of the ankle with 2% lidocaine ointment, a total of 240 units of botulinum toxin A must be administered (120 units per foot) once intradermal injection in 6 places on the perianal surface of the foot and the front of the ankles(12 points)
Category
Rehabilitation
2
Description
Control group: After covering the perianal surface of the foot and the front of the ankle on both sides with 2% lidocaine ointment, the same amount(240 unit toxin) of normal injectable saline 0.9% is injected intradermally in the same points (6 points 12 points total) on the perianal surface of the foot and ankles
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdyieh Hospital
Full name of responsible person
Masome Bayat
Street address
Mahdiye Hospital Fadaeiane Eslam St ,Shosh squre , Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
masume.Bayat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masome Bayat
Street address
Mahdiye Hospital Fadaeiane Eslam St ,Shosh squre , Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
11858117311
Phone
+98 21 5506 2628
Email
bayat.masume@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Masoon darou
Proportion provided by this source
80
Public or private sector
Private
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
Yasaman malekzade
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Mahdiye Hospital Fadaeiane Eslam St ,Shosh squre , Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
yasimalekztaheri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masume Bayat
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Mahdiye Hospital Fadaeiane Eslam St ,Shosh squre , Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
yasimalekztaheri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yasaman malekzade
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Mahdiye Hospital Fadaeiane Eslam St ,Shosh squre , Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1158817311
Phone
+98 21 5506 2628
Email
yasimalekztaheri@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the data of people participating in the study can be shared after de-identifying people.
When the data will become available and for how long
The access period starts one year after the results are published.
To whom data/document is available
The data of this study will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If the goal of the researchers is to perform a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers.
From where data/document is obtainable
by sending an e-mail to yasimalekztaher@gmail.com
What processes are involved for a request to access data/document
Sending an email requesting information and explaining the purpose and method of using data.