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The effect of Transcutaneous Electrical Nerve (TENS) on the restless leg syndrome (RLS) In patients with this complaint

Protocol summary

Study aim
Evaluation of the effect of transcutaneous electrical nerve stimulation (TENS) on severity of restless legs syndrome (RLS) in patients with this complaint
Design
The present study is a single blind randomized clinical trial. Patients who meet the eligibility criteria will be asked to complete a questionnaire. People with a score above 4 will be randomly divided into intervention and control groups (15 patients in each group).
Settings and conduct
The present study will be performed in the office of Internal medicine specialist. Both groups receive their usual treatment, which will be prescribed by an Internal medicine specialist. Before connecting them to the TENS device and after separating the device, RLS questionnaires will be completed. To match the working process, the PM70 2-channel TENS device manufactured by Iran will be used.
Participants/Inclusion and exclusion criteria
People with suspected RLS who have diagnostic criteria for RLS will receive an IRLSS questionnaire. Those with a score above 4 will be selected as the sample if they are eligible for the study. If they have a history of mental illness, vascular disease, neuromuscular disorders, experiencing a crisis for the past 3 months, taking antispasmodics, anticonvulsants, antidepressants, sedatives and herbal remedies and other non-pharmacological treatments during the past two weeks, will be excluded from the study.
Intervention groups
In this study, the TENS electric current is used at a frequency of 100 Hz, 3 times in three consecutive days, and each time, for 20 minutes. Due to the location of the complication, the electrodes are attached to the extremities (legs) and their efficacy is evaluated according to the patient's condition. In the intervention group, the TENS device with HZ100 frequency will be used.
Main outcome variables
Severity of restless leg syndrom

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191217045764N2
Registration date: 2021-02-01, 1399/11/13
Registration timing: registered_while_recruiting

Last update: 2021-02-01, 1399/11/13
Update count: 0
Registration date
2021-02-01, 1399/11/13
Registrant information
Name
Ali Abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3722 8634
Email address
abedia1371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-24, 1398/12/05
Expected recruitment end date
2021-04-25, 1400/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Transcutaneous Electrical Nerve (TENS) on the restless leg syndrome (RLS) In patients with this complaint
Public title
The effect of Transcutaneous Electrical Nerve (TENS) on the restless leg syndrome (RLS)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People over 35 years old Restless leg syndrome based on patient self-report Restless leg syndrome based on a doctor's diagnosis in the final step, score higher than 4 based on the standard questionnaire
Exclusion criteria:
History of neurological disease other than Restless Legs Syndrome Presence of vascular diseases other than restless legs syndrome according to the doctor's opinion Neuromuscular Disorders (Technique Problem) Experience the crisis over the past 3 months Patient's unwillingness to cooperate in design Severe stress to the individual or family over the past two weeks (death of a family member, ...) Intensification of RLS Use of antispasmodics over the past two weeks Use of anticonvulsants in the past two weeks Use of antidepressants over the past two weeks Use of sedatives over the past two weeks Using herbal remedies or any non-pharmacological treatments for treating restless legs syndrome over the past two weeks
Age
From 35 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Permissive blocks will be used for random allocation of patients. So we have 5 blocks with two repetitions in each block (BABA, BAAB, ABAB, AABB, ABBA) and we selected 10 numbers from the table of random numbers, so that if the numbers 1 and 0 were selected, the first block, the number 3 and 2, the second block, the number 5 and 4, the third block, 6 and 7 Blocks , the forth block, 8 and 9, the fifth block, were selected and the final allocation of samples was calculated from the sequence of these blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be unaware of being in the control and intervention groups. In order to not exchange information between the patients in the two groups; patients will be considered for interview and training in the separate room. Patients are reminded to not exchange information with other patients during the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Esfarayen University of Medical Sciences
Street address
No. 70, Imam Reza Alley12 , Imam Reza Ave
City
esfarayen
Province
North Khorasan
Postal code
9661876981
Approval date
2019-12-17, 1398/09/26
Ethics committee reference number
IR.ESFARAYENUMS.REC.1398.009

Health conditions studied

1

Description of health condition studied
Restless Legs Syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome

Primary outcomes

1

Description
Severity of restless leg syndrome
Timepoint
Before the start of the first stage intervention, before the start of the second stage intervention, before the start of the third stage intervention, the day after the third stage intervention.
Method of measurement
Using the International Restless Legs Syndrome Study Group (IRLSS) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, the transcutaneous electrical nerve stimulation (TENS) electric current is used at a frequency of 100 Hz, three times in three consecutive days, for 20 minutes. Due to the location of the complication, the electrodes are attached to the extremities (legs). The efficacy of TENS is evaluated according to the patient's condition. In the intervention group, the TENS device with HZ100 frequency will be used.
Category
Treatment - Devices

2

Description
Control group: in this group placebo TENS will be used. The leads connect to the lower extremities, but the device is off.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Internal Medicine Doctor's Office
Full name of responsible person
Dr. Mohammad Ghasem Tabey
Street address
No. 70, Imam Reza Alley12 , Imam Reza Ave
City
Esfarayen
Province
North Khorasan
Postal code
9661876981
Phone
+98 58 3155 0000
Email
dr-tabeiy@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Dr. Ali Asghar Neshat
Street address
No. 70, Imam Reza Alley12 , Imam Reza Ave
City
Esfarayen
Province
North Khorasan
Postal code
9661876981
Phone
+98 58 3155 0000
Email
Info@esfrums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfarayen 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
Esfarayen University of Medical Sciences
Full name of responsible person
Ali Abedi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 70, Imam Reza Alley12, Imam Reza Ave
City
Esfarayen
Province
North Khorasan
Postal code
9613873136
Phone
05144011300-6
Email
mtadayonfar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Ali Abedi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.70, Imam Reza Alley12 , Imam Reza Ave
City
Esfarayen
Province
North Khorasan
Postal code
9661876981
Phone
+98 58 3155 0000
Email
Abedia1371@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfarayen University of Medical Sciences
Full name of responsible person
Ali Abedi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.70, Imam Reza Alley12 , Imam Reza Ave
City
Esfarayen
Province
North Khorasan
Postal code
9661876981
Phone
+98 58 3155 0000
Email
Abedia1371@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The required data will appear in the article.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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