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A Comparison of the Effectiveness of Transcutaneous Electrical Nerve Stimulation and Duloxetine on Diabetic Peripheral Neuropathic pain

Protocol summary

Study aim
A Comparison of the Effectiveness of Transcutaneous Electrical Nerve Stimulation and Duloxetine on the pain caused by diabetic peripheral neuropathy
Design
A one-blinded,randomized clinical trial,phase 3 with parallel groups,design of 60 patients.
Settings and conduct
This study will be done at Pursina Hospital and Guilan Pain Clinic on patients with diabetic peripheral neuropathic pain who have not responded to previous therapies.60 patients randomly and with quadruple block method will be divided in two groups of TENS and Duloxetine.Patients will be visited weekly,during the first 4 weeks and then every 4 weeks.Patients will be followed up for 3 months. Patients will be assessed based on NRS (Numerical Rating Scale).Finally,results will be compared in two groups.In this study,the physician that evaluates patients after treatment is blind.But because of the method of administration,patients are aware of their treatment.
Participants/Inclusion and exclusion criteria
Entry criteria:patients type I or II diabetes mellitus,with diabetic neuropathic pain Resistant to usual drug treatments. Non-entry criteria:Having a pacemaker or defibrillator,Other neuropathies with causes other than diabetes.
Intervention groups
Tense group:In this group,an electrode will be placed above the wrist and another below the knee.Patients will receive a tense with the stimulator (E 3 model, Omran Location) for 20 minutes with these Specifications(80 Hz, 50 Amp, 0.2 ms Square Pulse 2 to 3 times sensory threshold).For four weeks, sessions will be held Every other day.Then, twice a week for three months. Duloxetine group:In this group,(20 milligrams tablets,Abidi Company),patients will receive 20 milligrams per day in the first week,40 milligrams per day in the second week and 60 milligrams since week 3 to 12.
Main outcome variables
Pain caused by diabetic peripheral neuropathy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110413006186N13
Registration date: 2019-05-27, 1398/03/06
Registration timing: prospective

Last update: 2019-05-27, 1398/03/06
Update count: 0
Registration date
2019-05-27, 1398/03/06
Registrant information
Name
Bahram Naderi Nabi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 4600
Email address
naderi_bahram@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of the Effectiveness of Transcutaneous Electrical Nerve Stimulation and Duloxetine on Diabetic Peripheral Neuropathic pain
Public title
The effect of electric stimulation through skin and duloxetine on diabetic neuropathic pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients type I or II diabetes mellitus, with diabetic neuropathic pain Resistant to usual drug treatments, at least for 6 months Minimum Pain Rating 4 based on Numerical Rating Having normal creatinine and CBC blood counts HBA1C less than 8%.
Exclusion criteria:
Having a pacemaker or defibrillator Having brain stimulators Infection or inflammation at the site of electrodes Other neuropathies with causes other than diabetes Alcohol consumption history Malignant history Tens Records history Pregnancy Bipolar patients Duloxetine contraindications such as liver or kidney failure and MAO-I simultaneous use
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To produce random sequences in this clinical trial, we will use this site: http://www.graphpad.com/quickcalcs/index.cfm.This study will be conducted as a pilot study in two groups of 30. The responsible physician for this study will randomly divide the patients into TENS (T) and Duloxetine (D) groups based on quadruple block method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Three months before starting the treatment, patients will be asked to discontinue all their analgesics and receive gabapentin 400-300 milligrams daily. After three months, if the symptoms of the patient are adequately controlled and there were no side effects, They will be excluded. Other patients who did not respond to the treatment will be randomly assigned to TENS (T) or Dolextine (D) by the responsible physician. In this study, the physician that evaluates patients after treatment is blind and unaware of the treatment group. But because of the method of administration, patients are aware of their treatment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Guilan University Of Medical Sciences
Street address
Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.GUMS.REC.1398.052

Health conditions studied

1

Description of health condition studied
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 caused by diabetic peripheral neuropathy
Timepoint
Before starting treatment, 1 month and 3 months after starting treatment
Method of measurement
Patients will be assessed based on NRS (Numerical Rating Scale)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Three months before the start of treatment, patients will be asked to discontinue all their analgesics and receive gabapentin 400-300 milligrams per day. If the symptoms of the patient were not adequately controlled with this drug and Or have side effects they will be excluded. Three months later, patients will randomly be divided into two groups: TENS (T) and Duloxetine (D).In group T, an electrode above the wrist and another will be placed below the knee. Patients will receive a tense scan (E 3 model, Omran Location) for 20 minutes with a ((80 Hz, 50 Amp, 0.2 ms Square Pulse 2 to 3 times sensory threshold) profile. For four weeks, sessions will be held Every other day. Then, twice a week for three months, patients undergo treatment with Tense. In the first 4 weeks, patients will be visited weekly and then every 4 weeks. Patients will be followed up for 3 months.
Category
Treatment - Devices

2

Description
Intervention group: In the duloxetine group (20 milligrams tablets, the Abidi Pharmaceutical Company), in the first week, 20 milligrams per day, in the second week, 40 milligrams per day , and from week 3 to 12 ,60 milligrams of duloxetine per day will be received. During the first 4 weeks,they will be visited weekly and then every 4 weeks.Patients will be follow up for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Bahram Naderi Nabi
Street address
Porsina Hospital
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3332 2444
Email
poursina@gums.ac.ir
Web page address

2

Recruitment center
Name of recruitment center
Guilan pain clinic
Full name of responsible person
Bahram Naderi Nabi
Street address
Second Floor,Guilan Building,next to Marlik MRI building,Golbagh Namaz,Rasht
City
Rasht
Province
Guilan
Postal code
4554553336
Phone
+98 13 3373 4539
Email
info@guilanpainclinic.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Doctor Shadman Nemati
Street address
Vice Chancellor for research of Guilan,Shahid Siadati Avenue, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
drshadmannemati_ent@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Dr Bahram Naderi Nabi
Position
Assosiate professor /Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Poursina Hospital
City
Rasht
Province
Guilan
Postal code
4193713189
Phone
+98 13 1321 0434
Fax
+98 13 1324 5140
Email
naderi_bahram@yahoo.com
Web page address
http://www.gums.ac.ir/arc

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Bahram Naderi Nabi
Position
Assosiate professor /Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Poursina Hospital
City
Rasht
Province
Guilan
Postal code
4193713189
Phone
+98 13 1321 0434
Fax
+98 13 1324 5140
Email
naderi_bahram@yahoo.com
Web page address
http://www.gums.ac.ir/arc

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohadese Ahmadi
Position
Research Expert/(MSc) English
Latest degree
Master
Other areas of specialty/work
Research Expert
Street address
Anestesiology Reseaech Center, Alzahra Hospital, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9328
Email
p.ahmadi2311@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
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
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