Comparison of the Effectiveness of Infrared radiation and Tecar Therapy with Infrared radiation on Peripheral Neuropathy in Patients with Type II Diabetes
Investigation of the Effect of Infrared radiation and Tecar Therapy with Infrared radiation on Peripheral Neuropathy in Patients with Type II Diabetes
Design
A Randomized, Single Blinds, Sham controlled clinical trial with Parallel Group Design of 24 Patients enrolled, and followed for six weeks
Settings and conduct
After evaluation of the intensity of pain, neurological disorders, tactile sensation of the feet and tibial nerve conduction velocity, patients were randomly divided into control and treatment groups. They were treated at the physiotherapy clinic of Rehabilitation faculty of Shahid Beheshti University of Medical Sciences.
Patients were treated on separate days and were not aware of their placement in the treatment and control groups, so blinding was only applied to the participants of the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Age: 18-75; The least duration of illness affliction was more than six months; Patients have type II diabetes Mellitus with signs and Symtoms of mild(I) to moderate(II) Peripheral Neuropathy; Pain Intensity which was based on VAS ( Visual Analog Scale) scores were more than three. Exclusion Criteria:Pregnancy; Diabetic Infectious Wound; Involvement of Cardiovascular system; Involvement of Respiratory system; To have Pace maker
Intervention groups
Treatment Group: Patients in the Treatment Group were treated with Infrared radiation and Tecar Therapy
Control Group: Patients in the Control Group were treated with Infrared radiation and Sham Tecar Therapy
Main outcome variables
Intensity of pain based on visual analogue scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190726044337N1
Registration date:2019-10-20, 1398/07/28
Registration timing:retrospective
Last update:2019-10-20, 1398/07/28
Update count:0
Registration date
2019-10-20, 1398/07/28
Registrant information
Name
Maryam Niajalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4222 4593
Email address
maryam_niajalili@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-08, 1398/01/19
Expected recruitment end date
2019-08-29, 1398/06/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Infrared radiation and Tecar Therapy with Infrared radiation on Peripheral Neuropathy in Patients with Type II Diabetes
Public title
The Effect of Tecar Therapy on Peripheral Neuropathy in Patients with Type II Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 18-75
The least duration of illness affliction was more than six months
Patients have type II diabetes Mellitus with signs and Symtoms of mild(I) to moderate(II) Peripheral Neuropathy
Pain Intensity which was based on VAS (Visual Analog Scale) scores were more than three
Exclusion criteria:
Pregnancy
Diabetic Infectious Wound
Involvement of Cardiovascular system
Involvement of Respiratory system
To have Pace maker
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization: Patients were assigned a number according to the order of selection and were divided into treatment and control groups by sortition. The first pulled out number was assigned to the treatment group and the subsequent numbers were assigned to the two groups, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the Participants of the Study were Blinded and did not know which of the two treatment and control groups were assigned to them.That way, the Individuals in both groups were treated on separate days.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
3th Floor, Medical school, Next to the Taleghani Hospital, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.713
Health conditions studied
1
Description of health condition studied
Type II Diabetes
ICD-10 code
E11.4
ICD-10 code description
Type 2 diabetes mellitus with neurological complications
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before treatment, after ten session, Follow up for six weeks
Method of measurement
Base on visual analogue scale
Secondary outcomes
1
Description
Tactile sensation of feet
Timepoint
Before treatment, After ten session, Follow up for six weeks
Method of measurement
Monofilament 5.07/10 g
Intervention groups
1
Description
Intervention group: Patients in this group are treated with Infrared radiation (electromagnetic fields with 890 nanometers ,70-80 centimeters away from the surfaces of the foot) for 60 minutes and Capacitive Tecar Therapy (electromagnetic fields with 300-800 Kilohertz and intensity less than 50%) on Tibial nerve pathway with for 20 minutes in each session.Infrared radiation treatment is applied to dorsal, plantar, medial and lateral surface of the feet for twenty minutes and then, the passive electrode of tecar device is placed anterior surface of legs and its active electrode is moved along the tibial nerve pathway for twenty minutes in prone position.
Category
Rehabilitation
2
Description
Control group: Patients in this group are treated with Infrared radiation (electromagnetic fields with 890 nanometers , 70-80 centimeters away from the surfaces of the foot) for 60 minutes and Sham Capacitive Tecar Therapy (electromagnetic fields with 300-800 Kilohertz and Zero intensity ) on Tibial nerve pathway with for 20 minutes in each session.Infrared radiation treatment is applied to dorsal, plantar, medial and lateral surface of the feet for twenty minutes and then, the passive electrode of tecar device is placed anterior surface of legs and its active electrode is moved along the tibial nerve pathway for twenty minutes in prone position; except that the current intensity is zero.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic of School of Rehabilitation Shahid Beheshti University of Medical Science
Full name of responsible person
Maryam Niajalili
Street address
No. 9, Kheyri Alley, Sardar-e Jangal Ave
City
Lahijan
Province
Guilan
Postal code
4418786769
Phone
+98 13 4222 4593
Email
Maryam_Niajalili@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3th Floor, Medical school, Next to the Taleghani Hospital, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9780
Email
zarghi@smbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
1
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Niajalili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 9, Kheyri Alley, Sardar-e Jangal Ave
City
lahijan
Province
Guilan
Postal code
4418786769
Phone
+98 13 4222 4593
Email
Maryam_Niajalili@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Asghar Rezasoltani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Shahid Beheshti University of Medical Science, Damavand Ave, Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
009877561721
Email
A_rezasoltani@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Niajalili
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 9, Kheyri Alley, Sardar-e Jangal Ave
City
Lahijan
Province
Guilan
Postal code
4418786769
Phone
+98 13 4222 4593
Email
Maryam_Niajalili@sbmu.ac.ir
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