Comparison of efficacy of nortriptyline with Transcutaneous Electrical Nerve Stimulation (TENS) on painful peripheral neuropathy in patients with diabetes
The comparison of efficacy of TENS and Nortriptyline on pain reduction in patients with painful peripheral neuropathy caused by diabetes.
Design
This is a controlled double-blind clinical trial study conducted on 42 patients with painful peripheral neuropathy caused by type 1 or type 2 diabetes mellitus. Patients (N = 21per group) were randomly treated with TENS (18 sessions, each session 30 minutes) or Nortriptyline (25 to 75 mg, once daily) for 6 weeks.
Settings and conduct
This controlled double-blind clinical trial study was conducted on 42 patients with painful peripheral neuropathy caused by type 1 or type 2 diabetes mellitus referring to Golestan Hospital in Ahvaz in 2017-18. Patients were evaluated for side effects and pain relief using visual analog scale (VAS) every week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, Consent to participate in the study, Patients with diabetic painful peripheral neuropathy; Exclusion criteria: Patients with other causes of neuropathy, renal dysfunction, liver disease, uncontrolled hypertension, malignancy.
Intervention groups
Treatment with TENS (18 sessions) or Nortriptyline (25 to 75 mg)
Main outcome variables
Pain severity (using VAS) and side effects of the drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180212038705N2
Registration date:2018-06-26, 1397/04/05
Registration timing:retrospective
Last update:2018-06-26, 1397/04/05
Update count:0
Registration date
2018-06-26, 1397/04/05
Registrant information
Name
Fariba Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 2242
Email address
heidari.p@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-06, 1396/08/15
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
2017-11-06, 1396/08/15
Actual recruitment end date
2018-03-19, 1396/12/28
Trial completion date
empty
Scientific title
Comparison of efficacy of nortriptyline with Transcutaneous Electrical Nerve Stimulation (TENS) on painful peripheral neuropathy in patients with diabetes
Public title
Comparison of efficacy of Nortriptyline with TENS on painful diabetic peripheral neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years
Type 1 and 2 diabetes
Definitive diagnosis of diabetic neuropathy
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
42
Actual sample size reached:
39
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Both patients and and researchers did not know about type of treatment and patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jundishapour University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61355393
Approval date
2017-10-04, 1396/07/12
Ethics committee reference number
IR.AJUMS.REC.1396.605
Health conditions studied
1
Description of health condition studied
Painful diabetic peripheral neuropathy
ICD-10 code
E11.40
ICD-10 code description
Type 2 diabetes mellitus with diabetic neuropathy, unspecified
Primary outcomes
1
Description
Pain severity
Timepoint
Every week
Method of measurement
Visual analog scale (VAS)
Secondary outcomes
1
Description
Side effects
Timepoint
Every week
Method of measurement
Examination and patient history
Intervention groups
1
Description
Intervention group: Nortriptyline (25 to 75 mg)
Category
Treatment - Drugs
2
Description
Intervention group: TENS
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
دکتر مهرنوش ذاکرکیش
Street address
Golestan Hospital, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Zakerkish@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh ZakerKish
Street address
Jundishapour University of Medical Sciences, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Zakerkish@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology
Street address
Golestan Hospital, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Zakerkish@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Davood Reisi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golestan Hospital, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
reisidavood@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Davood Reisi
Position
Internal Medicine Residency
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golestan Hospital, Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
reisidavood@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available