Comparison of the effect of acupuncture points and infrared light on the severity of restless legs syndrome
Design
This clinical trial design has a control and intervention group, with parallel, double-blind and simple random groups.
Settings and conduct
This clinical trial study will be conducted on patients with this syndrome in 8 sessions of Transcutaneous Electrical Acupoint Stimulation and infrared light points after using restless legs syndrome universal questionnaire. Participants and statistical analysts will perform.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
Having restless legs syndrome
Age range between 18 and 65 years
Not being cancer
Not receiving pharmacological and non-pharmacological treatment to relieve restless leg syndrome
Not having pacemaker
Exclusion criteria:
Failure to attend more than 3 sessions
Using Restless Foot Syndrome Soothing Medications
Migration
Death
Intervention groups
Transcutaneous Electrical Acupoint Stimulation group
Infrared group
Main outcome variables
Severity of restless leg syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190925044884N1
Registration date:2019-12-24, 1398/10/03
Registration timing:registered_while_recruiting
Last update:2019-12-24, 1398/10/03
Update count:0
Registration date
2019-12-24, 1398/10/03
Registrant information
Name
mohammad nazarianpirdosti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4512 6851
Email address
mnazarianpirdosti@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Transcutaneous Electrical Acupoint Stimulation and Infrared on the Severity of the restless leg Syndrome
Public title
Comparison of the Effect of Transcutaneous Electrical Acupoint Stimulation and Infrared on the Severity of the restless leg Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
Having restless legs syndrome
Age range between 18 and 65 years
Not being cancer
Not receiving pharmacological and non-pharmacological treatment to relieve restless leg syndrome
Not having pacemaker
Exclusion criteria:
Failure to attend more than 3 sessions
Using Restless Foot Syndrome Soothing Medications
Migration
Death
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used. The random number table will be used to select the samples and place them in the intervention and control modes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in this study will not know which of the intervention and control groups they belong to. The data analyzer also does not know which data belongs to which group.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Branch of researchs and industry,Kermanshah University Of Medical Sciences, Shahid Beheshti Blvd, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-09-17, 1398/06/26
Ethics committee reference number
IR.KUMS.REC.1398.686
Health conditions studied
1
Description of health condition studied
Restless leg syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
Primary outcomes
1
Description
In this study, we compared the effect of acupuncture points and infrared light on the severity of restless legs syndrome using the restless legs syndrome universal questionnaire whose score is below 4.
Timepoint
In this study, we compared the efficacy of acupuncture points and infrared light on the severity of restless leg syndrome, the first measurement with a pre-test and the second with a post-test, and the third measurement to determine whether the method was effective. Whether or not treatment will continue, one month after the end of treatment, re-treatment will be perform
Method of measurement
Restless Foot Syndrome World Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Transcutaneous Electrical Acupoint Stimulation.In the electrical stimulation intervention group, skin stimulation was performed with AcuHealth (Australian Made) at specified locations.Electrical stimulation of the specimens was performed for each sample for 4 consecutive weeks, 3 times a week, and every 5 minutes.
Category
Treatment - Devices
2
Description
Intervention group: Infrared.In the infrared intervention group, infrared light therapy sessions are conducted in two sessions, with each individual in the intervention group being treated three times a week for one month. The BioBeam940 (Israel-made) portable, FDA-approved, portable, hand-held device is used to conduct infrared light therapy sessions. In this regard, the 2 nm wavelength in the NIR range, with a power of 1 mW / cm2, a frequency of 2 Hz, a maximum focusing power of 2 mW, and a 2 degree radiation angle are applied to each acupuncture point of each foot as well as the entire plantar surface of each. The foot will be exposed to infrared light It should be noted that the energy transfer to each acupuncture point is two minutes in order to transmit energy to the foot from the method used in the bath so that the infrared probe in The whole plantar surface will move about for 5 minutes, so each person will have to walk 5 minutes in total. Session receives infrared light.
Category
Treatment - Devices
3
Description
Control group: Intervention group: Transcutaneous Electrical Acupoint Stimulation.While the sessions in the control group will be administered in the form of dummy treatment, the researcher only pretends that he is undergoing electrical stimulation therapy in the control group, but in fact, the acupuncture points of these individuals are not stimulated.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences Research Center for Sleep Disorders
Full name of responsible person
Behnam Khaledi Paveh
Street address
Farabi Hospital, Dollat Abad, Kermanshah, Iran
City
kermnshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 8326 5255
Email
bkhaledipaveh@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farzaneh Saadat Hosseini
Street address
Branch of researchs and industry,Kermanshah University Of Medical Sciences, Shahid Beheshti Blvd, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8258
Email
daftarriast@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Nazarian Pirdosti
Position
nursing student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Farabi Hospital, Dollat Abad, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 4512 6851
Email
mnazarianpirdosti@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behnam Khaledi Paveh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Farabi Hospital, Dollat Abad, Kermanshah, Iran
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3816 2401
Email
bkhaledipaveh@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behnam Khaledi Paveh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kermanshah, Dollat Abad, School of Nursing and Midwifery.
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3816 2401
Fax
Email
bkhaledipaveh@kums.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