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The effects of botulinum toxin type A injections on pain symptoms, quality of life and sleep quality of patients with diabetic neuropathy : A randomized double-blind clinical trial

Protocol summary

Study aim
The present study was conducted to compare the effect Butolinium Toxin A on lower limb neuropathic pain, quality of life and sleep in Diabetic neuropathic patients , with a group of them receiving the placebo.
Design
Two study groups of 19 diabetic patients with lower limbs neuropathy in each group, with simple randomization , single center
Settings and conduct
At first, 50 patients with sensory and motor complaints were evaluated. Of these, 38 patients with type 2 diabetes aged 40-70 years who admitted to the Diabetes Clinic of AIA Hospital in Rafsanjan, were selected based on criteria. patients and investigator were blinded to injected material.
Participants/Inclusion and exclusion criteria
inclusion :Having type 2 diabetes for at least 3 years, being aged 40-70 years, providing a positive response to four or more questions in DN4 , and evidence of diabetic neuropathy in lower limb electrophysiological examination Exclusion: who were allergic to BTX-A, those who used other drugs to reduce neuropathic pain or had a history of myasthenia gravis, subjects with muscle weakness, kidney dysfunction, and history of alcohol use, post-operative patients, those who initiated taking medication after the onset of the study, as well as those who developed aminoglycosides or obstructive airway disease
Intervention groups
,100 units BTX-A (Dysport-Ipsen, UK) was dissolved in 1.2 ml of normal saline and intrathecal (intradermal) according to the grid pattern of 12 points ( 3 × 4) on the foot surface and injected into the subject's leg (8 units out of 12 were injected in each site) In placebo group the same volume of normal saline was injected in 12 points on foot surface.
Main outcome variables
Quality of life :SF-36 standard questionnaire Pain quality and severity :Neuropathic Pain Scale Pain severity :Visual Analogue Scale Sleep Quality :The Pittsburgh Sleep Quality Index .

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190129042540N1
Registration date: 2019-03-12, 1397/12/21
Registration timing: retrospective

Last update: 2019-03-12, 1397/12/21
Update count: 0
Registration date
2019-03-12, 1397/12/21
Registrant information
Name
Alireza Vakilian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 9393
Email address
alirezavakilian66@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-01-06, 1395/10/17
Expected recruitment end date
2018-03-03, 1396/12/12
Actual recruitment start date
2018-02-04, 1396/11/15
Actual recruitment end date
2018-04-04, 1397/01/15
Trial completion date
2018-10-08, 1397/07/16
Scientific title
The effects of botulinum toxin type A injections on pain symptoms, quality of life and sleep quality of patients with diabetic neuropathy : A randomized double-blind clinical trial
Public title
botulinum toxin type A and diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes for at least 3 years 40-70 years old providing a positive response to four or more questions in DN4 test evidence of diabetic neuropathy in lower limb electrophysiological examination
Exclusion criteria:
who were allergic to BTX-A using other drugs to reduce neuropathic pain a history of myasthenia gravis subjects with distal muscle weakness kidney dysfunction history of alcohol use post-operative patients who initiated taking medication after the onset of the study who used aminoglycosides peripheral vascular obstructive disease
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 50
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization: To randomize individuals, two groups of random number table method was used. Therefore the direction of reading the numbers was chosen towards the right side. Even numbers were considered for the intervention group and odd numbers was considered for the placebo group
Blinding (investigator's opinion)
Double blinded
Blinding description
investigator and patients are blind in this study . Other collegues such as nurse and who inject Dysport and analyzer are not blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Central Organization of Rafsanjan University of Medical Siences, Imam Ali Avenue. Rafsanjan .
City
rafsanjan
Province
Kerman
Postal code
7718796755
Approval date
2017-01-01, 1395/10/12
Ethics committee reference number
IR.RUMS.REC.1395.116

Health conditions studied

1

Description of health condition studied
Diabeticr polyneuropathy
ICD-10 code
E10.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy

Primary outcomes

1

Description
severity of pain
Timepoint
in the beginning of study and 1, 4, 8, and 12 weeks after intervention
Method of measurement
Pain Visual Analogue Scale

2

Description
quality of life
Timepoint
in the beginning of study and 1, 4, 8, and 12 weeks after intervention
Method of measurement
Short Form-36Quality-of-Life Questionnaire

3

Description
Severity and quality of pain
Timepoint
in the beginning of study and 1, 4, 8, and 12 weeks after intervention
Method of measurement
Neuropathic Pain Scale

4

Description
Sleep quality
Timepoint
in the beginning of study and 1, 4, 8, and 12 weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Index questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: Patients receive the Toxin Botulinum A at the 8 units out of 12 points injected in each site according to the grid pattern
Category
Treatment - Drugs

2

Description
Control group:Patients receive the normal saline as the same volume injected in each point according to the grid pattern
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetic clinic of Ali Ibn Abitalib Hospital
Full name of responsible person
Alireza Vakilian
Street address
Ali-Ibn-Abitalib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717653995
Phone
+98 34 3428 0001
Fax
+98 34 3428 0022
Email
alirezavakilian&@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
Central Organization of Rafsanjan University of Medical Sciences. Imam Ali Avenue, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
+98 34 3425 8294
Email
alishamsy@gmail.com
Web page address
https://www.rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Alireza Vakilian
Position
associate professor ,
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No1,4th Alley, Imam Aven. Rafsanjan .
City
Rafsanjan
Province
Kerman
Postal code
7717653995
Phone
+98 34 3428 9393
Fax
+98 34 3428 9393
Email
alirezavakilian7@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Alireza Vakilian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
1,4th Alley,Imam Avenue,
City
Rafsanjan
Province
Kerman
Postal code
7717653995
Phone
+98 34 3428 9393
Fax
+98 34 3428 9393
Email
alirezavakilian7@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Alireza Vakilian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No.1,4th Alley,Imam Ave
City
Rafsanjan
Province
Kerman
Postal code
7717653995
Phone
+98 34 3428 9393
Fax
Email
alirezavakilian66@rums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We decided to present it in an article.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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