Comparison of Pulsed Radiofrequency and Transcutaneous electrical nerve stimulation on decreasing of Diabetic neuropathy symptoms in Lower extremity in patients who did not respond to medications
This study is a randomized-controlled trial. The sample of study is diabetic patients who have been referred to the Pain clinic because of persistent pain and paresthesia in lower extremity. The entire patients are enrolled in the study after consideration of inclusion and exclusion criteria and informed consents are obtained. All the study subjects will be followed-up regarding pain and paresthesia in lower extremity with numeric rating scale score. The study patients are divided into two groups. Group 1 patients receive pulsed radiofrequency on lumbar sympathetic chain and group 2 patients receive TENS on lower extremity. patients will be followed with numeric rating scale score due to their severity of pain and paresthesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212166186N1
Registration date:2012-12-20, 1391/09/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-20, 1391/09/30
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
research office of anesthesiology and pain management, guilan university of medical sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Pulsed Radiofrequency and Transcutaneous electrical nerve stimulation on decreasing of Diabetic neuropathy symptoms in Lower extremity in patients who did not respond to medications
Public title
Comparison of Pulsed Radiofrequency and TENS on decreasing of Diabetic neuropathy symptoms in Lower extremity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: diabetic patients who have been referred to the "Pain clinic" because of persistent pain and paresthesia in lower extremity who did not respond to oral medications.
Exclusion criteria: coagulopathy; anti platelet and anticoagulant therapy; local infection at the procedure site; advanced stages of diabetic neuropathy without paresthesia and pain; addiction; cardiac pacemaker; epilepsy and pregnancy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research office of guilan university of medical sciences
Street address
gas square, western shahid beheshti blvd, in front of sepah bank
City
rasht
Postal code
4193893345
Approval date
2012-10-23, 1391/08/02
Ethics committee reference number
1910231201
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
G99*
ICD-10 code description
Diabetic autonomic neuropathy
Primary outcomes
1
Description
pain
Timepoint
before intervention, 7th day and 1st month and 3rd month after intervention
Method of measurement
numeric rating scale score
2
Description
paresthesia
Timepoint
before intervention, 7th day and 1st month and 3rd month after intervention
Method of measurement
numeric rating scale score
Secondary outcomes
empty
Intervention groups
1
Description
for TENS group after cleaning the skin with alcohol, patch electrodes will be attached to the skin of lateral inferior part of knee and forfoot. then electrical impulses will be generated with 80 Hz and 50 mA for 20 minutes. there will be 10 sessions of TENS daily.
Category
Treatment - Devices
2
Description
for RF group in operation room with fluoroscopic guide, the patient will be in prone position and RF needle will be inserted percutaneously from lumbar region to the lumbar sympathetic chain in anterolateral portion of L2 L3 and L4 vertebrates. the needle position will be approved by injection of omnipaque 240 and sensory and motor stimulating test.patients will receive 3 cycles of pulsed radiofrequency lasting for 180 seconds for each of the vertebrates.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
poursina hospital
Full name of responsible person
amir hossein fathi
Street address
namjoo street
City
rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research office of anesthesiology and pain, guilan university of medical sciences
Full name of responsible person
abas sedighinejad
Street address
namjoo street, poursina hospital
City
rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research office of anesthesiology and pain, guilan university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
guilan university of medical sciences
Full name of responsible person
bahram naderi nabi
Position
assistant professor of anesthesiology-fellowship of interventional pain management
Other areas of specialty/work
Street address
sadi street, baharestan building, 4th floor
City
rasht
Postal code
4157658434
Phone
+98 13 1723 8889
Fax
+98 13 1723 2166
Email
naderi_bahram@gums.ac.ir naderi_bahram@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
guilan university of medical sciences
Full name of responsible person
bahram naderi nabi
Position
assistant professor of anesthesiology-fellowship of interventional pain management
Other areas of specialty/work
Street address
sadi street, baharestan building, 4th floor
City
rasht
Postal code
4157658434
Phone
+98 13 1723 8889
Fax
+98 13 1723 2166
Email
naderi_bahram@gums.ac.ir naderi_bahram@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
guilan university of medical sciences
Full name of responsible person
bahram naderi nabi
Position
assistant professor of anesthesiology- fellowship of interventional pain management
Other areas of specialty/work
Street address
sadi street, baharestan building, 4th floor
City
rasht
Postal code
4157658434
Phone
+98 13 1723 8889
Fax
+98 13 1723 2166
Email
naderi_bahram@gums.ac.ir naderi_bahram@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)