The aim of this study was to evaluate its efficacy and appropriate types of Transcutaneous Electrical Nerve Stimulation (TENS) for relieving pain in patients with neuropathy. Inclusion criteria were pain for more than 6 months, clinical symptoms of neuropathy and paraclinical symptoms of poly neuropathy. Exclusion criteria were using a pace maker, pain due to osteoarthritis and vascular diseases, radiculopathy, wound , infection and traumatic lesions in lower limbs. The sample size for each group were 13 patients.The diabetic Patients who referred to Endocrinology and Metabolism Research Centers for their monthly checkup, were referred to the study, if they were complying from neuropathy pain. thrity nine subjects with diabetes mellitus type II who complained from neuropathy pain were selected. The subjects were assigned into three groups. Two kinds of electrical nerve stimulation (TENS and Diadynamic) were used for two groups, and the last one received sham stimulation. They were treated in two steps. Outcome measures: Changes in pain were measured using qualitative pain score (from 0 to 5) and visual analogue scale (VAS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103176083N1
Registration date:2013-10-07, 1392/07/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-07, 1392/07/15
Registrant information
Name
Abbas Ali Pourmomeny
Name of organization / entity
School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2024
Email address
pourmomeny@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Reseach Center of Medical Scences
Expected recruitment start date
1990-01-01, 1368/10/11
Expected recruitment end date
1990-01-01, 1368/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of electroanalgesia on relieving the pain of peripheral poly neuropathy in patients with type II
Public title
The effect of electroanalgesia on relieving the pain of peripheral poly neuropathy in patients with type II diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
pain due to neuropathy in diabetic patients
pain Excepts due to neuropathy in diabetic patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Bioethics Committee of Isfahan University of Medical Scineces
Street address
Regional Bioethics Committee, Isfahan University of Medical Scineces
City
Isfahan
Postal code
Approval date
2001-09-23, 1380/07/01
Ethics committee reference number
80076
Health conditions studied
1
Description of health condition studied
dibetic polyneuropathy
ICD-10 code
G63.2
ICD-10 code description
Diabetic polyneuropathy
Primary outcomes
1
Description
pain
Timepoint
befor treatment, aftre treatment
Method of measurement
visual analog scale(VAS)
Secondary outcomes
1
Description
pain
Timepoint
pain
Method of measurement
visual Analog Scale(VAS)
Intervention groups
1
Description
Transcutaneous Electrical Nerve Stimulation(TENS) in Lower Ext. for 30 minutes every day during 2 weeks
Category
Rehabilitation
2
Description
Transcutaneous Electrical Nerve Stimulation(Diadynamic) in Lower Ext. for 30 minutes,every day during 2 weeks
Category
Rehabilitation
3
Description
placebo Transcutaneous Electrical Nerve Stimulation(TENS) in Lower Ext. for 30 minutes,every day during 2 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
diabetic centre
Full name of responsible person
Amini
Street address
Isfahan, Diabetic Centre
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center, Isfahan University of Medical Sciences
Full name of responsible person
Adibi-ََIsfahan University of Medical Sciences
Street address
Research center of Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center, Isfahan 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
Rehabilitation Sciences, Isfahan University of Medical Sciences
Full name of responsible person
pourmomeny
Position
Instructor
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
+98 31 1791 2024
Fax
Email
pourmomeny@rehab.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences, Isfahan University of Medical Sciences
Full name of responsible person
Pourmomeny
Position
Instrctor
Other areas of specialty/work
Street address
Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2024
Fax
Email
pourmomeny@rehab.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)