The aim of this study is evaluating the efficacy of a non-pharmacological treatment "accupuncture" for treating refractory trigeminal neuralgia
Design
In this clinical trial with one group which is without control group, 20 patients will receive acupuncture.
Settings and conduct
This study will be done on patients with refractory trigeminal neuralgia who will be referred to Oral & Maxillofacial Department of Shiraz Dental Faculty and Emam Reza clinic during 2018-2019. Sinew channel method of acupuncture will be accomplished for participants. No control group has been designed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The Patients with refractory trigeminal neuralgia since more than 3 months ago;
The participants who sign the written consent form.
Non inclusion criteria:
Patients with Diabetes mellitus;
Patients with cerebrovascular diseases;
Patients with skin problems or hypersensitivity.
Intervention groups
The participants with refractory trigeminal neuralgia will receive acupuncture treatment.
Sinew channel method of acupuncture will be accomplished for participants 3 sessions in a week for 10 sessions (3 weeks). The pharmacological treatment will continue during acupuncture therapy.
Main outcome variables
Visual analogue scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120101008585N8
Registration date:2019-05-24, 1398/03/03
Registration timing:registered_while_recruiting
Last update:2019-05-24, 1398/03/03
Update count:0
Registration date
2019-05-24, 1398/03/03
Registrant information
Name
Fatemeh Lavaee
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1631 9309
Email address
lavaeef@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of acupuncture on pain of patients with trigeminal neuralgia
Public title
effect of acupuncture on trigeminal neuralgia pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Patients who have been under pharmacological treatment since at least 3 months ago for trigeminal neuralgia and they still suffer from pain
The participants who sign the written consent form
Exclusion criteria:
The Patients who have been under pharmacological treatment since less than 3 months ago for trigeminal neuralgia
Patients with Diabetes mellitus
Patients with cerebrovascular diseases
Patients who have any history of dermal skin problems or hypersensitivity
Age
From 15 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Namazi square, Zand street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7186781559
Approval date
2019-02-06, 1397/11/17
Ethics committee reference number
ir.sums.rec.1398.100
Health conditions studied
1
Description of health condition studied
trigeminal neuralgia
ICD-10 code
G50.0
ICD-10 code description
Trigeminal neuralgia
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, before each session of 10 sessions of acupuncture
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient in intervention group will receive acupuncture. Sinew channel method of acupuncture will be accomplished for participants, 3 sessions in a week for 10 sessions (3 weeks). The pharmacological treatment will continue for participants during acupuncture therapy. The pain severity of patients will be evaluated by visual analogue scale (VAS) in days 0,7,14,21. In sinew channel method the Ashi points, GB20, SJ5, ST40, ST36 will be used for acupuncture.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Fateme Lavaee
Street address
Shiraz Dental School, Ghasrdasht street, Shiraz
City
Shiraz
Province
Fars
Postal code
7186781559
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
empty
Title of funding source
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Ghhasemi
Street address
Shiraz university of Medical Sciences, Zand street, Iran
City
Shiraz
Province
Fars
Postal code
7186782559
Phone
+98 71 3212 2438
Email
ghasemim@summs.ac.ir
Grant name
Grant code / Reference number
97-01-99-18108
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Assistant Professor of Oral and Maxillofacial Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7186781559
Phone
+98 71 3631 9309
Email
lavaeef@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Assistant Professor of Oral and Maxillofacial Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7186781559
Phone
+98 71 3631 9309
Email
lavaeef@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Assistant Professor of Oral and Maxillofacial Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7186781559
Phone
+98 71 3626 3193
Email
lavaeef@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data will be shared after deidentification of participants.
When the data will become available and for how long
6 months after publication data will become available.
To whom data/document is available
The researchers in academic institutions.
Under which criteria data/document could be used
The researchers in academic institutions.
From where data/document is obtainable
The researchers in academic institutions can send their request to responsible person via email and request information
What processes are involved for a request to access data/document
The researchers in academic institutions can send their request to responsible person via email and request information