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evaluation of the effect of acupuncture in control of the symptoms in patients with restless leg syndrome

Protocol summary

Summary
This study is a randomized, single-blind, non-placebo controlled and single-center clinical trial. The aim of this study is to compare the efficacy of Acupuncture and gabapentin versus gabapentin as a standard treatment for treating the Restless Legs Syndrome. This study includes 46 patients who have Restless Legs Syndrome for over 6 months and have the four diagnostic criteria for Restless Legs Syndrome. Patients with Pregnancy, immune deficiency, cancer, diffuse skin lesions, pacemaker, coagulation disease, infection on the area of acupuncture are not enrolled. Also patients who have systemic disorder such as iron deficiency anemia, thyroid dysfunction, renal failure will be excluded. Using block randomization, patients are categorized to one of two groups: 1. Acupuncture and gabapentin as an intervention group, 2. gabapentin as a control group. All patients after giving ethical consent undergo treatment with 300mg gabapentin tablet daily. Patients in intervention group undergo electro acupuncture for 10 sessions. If after 4 weeks the signs of the patients improved less than 30% according to VAS increase the dosage of gabapentin. Both groups of patients are evaluated by resident of Physical medicine and rehabilitation who are not aware of the type of treatment. This evaluation is performed before, a month later and 2 month after treatment (by visit) via IRLSSG و Pittsburg questioners and Visual analog scales. Finally, statistical comparison of results will perform.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015102724742N1
Registration date: 2015-11-19, 1394/08/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-19, 1394/08/28
Registrant information
Name
Samaneh Ghahramanpoori
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8876 7305
Email address
s.ghahramanpoori@gmail.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of the effect of acupuncture in control of the symptoms in patients with restless leg syndrome
Public title
evaluation of the effect of acupuncture in control of the symptoms in patients with restless leg syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: men and women 18 years old up to 65 years old who have restless legs with duration more than 6 month and have the four diagnostic criteria for Restless Legs Syndrome: 1- an urge to move the legs, 2- that is present at rest, 3- relieved by movement, 4- demonstrates a circadian pattern with peak symptoms occurring at night or in the evening. exclusion criteria: patients who have treatable systemic disorder such as renal failure; iron deficiency anemia; thyroid dysfunction; Patients with Pregnancy; immune deficiency; coagulation disease; cancer; diffuse skin lesions; cardiac pacemaker; infection on the areas of acupuncture also other neurologic disorder such as levodopa dependent dyskinesia; neuroleptic dependent akathisia; Tourette syndrome; attention deficit hyperactivity disorder(ADHD) and anxiety disorders.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences
Street address
6th floor, Central Organization of university, Keshavarz Boulevard, Tehran
City
Tehran
Postal code
Approval date
2014-07-06, 1393/04/15
Ethics committee reference number
105/1680/د/93

Health conditions studied

1

Description of health condition studied
restless leg syndrome
ICD-10 code
G25.8
ICD-10 code description
Other specified extrapyramidal and movement disorder: Restless legs syndrome Stiff-man syndromes

Primary outcomes

1

Description
severity of leg restlessness
Timepoint
in start of study, first month and second month after start of study.
Method of measurement
International Restless Legs Syndrome Study Group(IRLSSG) questionnaire

2

Description
severity of leg restlessness
Timepoint
in start of study, first month and second month after start of study.
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: underwent treatment of 300 mg gabapentin daily concomitant of 10 session 40 HZ frequency electro Acupuncture over 30 minutes over maximum 3 session in weeks during 4 weeks. If after 4 weeks the signs of the patients improved less than 30% according to VAS increase the dosage of gabapentin.
Category
Treatment - Other

2

Description
Control group: underwent treatment of 300 mg gabapentin daily. If after 4 weeks the signs of the patients improved less than 30% according to VAS increase the dosage of gabapentin.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of physical medicine and rehabilitation, Firoozgar Hospital
Full name of responsible person
Samaneh Ghahramanpoori, Resident of physical medicine and rehabilitationi
Street address
Firoozgar Hospital, Beh Afarin Street, Karim Khan e Zand Avenue, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehrdad Eftekhar MD
Street address
School of medicine, Iran University of Medical Sciences, Hemat avenue, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Department of physical medicine and rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Samaneh Ghahramanpoori
Position
physical medicine and rehabilitation resident, Medical Doctor
Other areas of specialty/work
Street address
Firoozgar Hospital, Beh Afarin Street, Karim Khan e Zand Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
+98 21 8894 2970
Email
s.ghahramanpoori@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of physical medicine and rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Simin Sajadi
Position
Physical medicine and rehabilitation specialist, Professor Assistance.
Other areas of specialty/work
Street address
Firoozgar Hospital, Beh Afarin Street, Karim Khan e Zand Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 218214122
Fax
+98 21 8894 2970
Email
dr.sajadi_pmr@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of physical medicine and rehabilitation, Iran University of Medical Sciences.
Full name of responsible person
Samaneh Ghahramanpoori
Position
physical medicine and rehabilitation resident, Medical Doctor
Other areas of specialty/work
Street address
Firoozgar Hospital, Beh Afarin Street, Karim Khan e Zand Avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
+98 21 8894 2970
Email
s.gharamanpoori@gmail.com ghahramanpoorisamaneh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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