Evaluation of the therapeutic effect of acupuncture
Evaluation of the therapeutic effect of acupuncture for the treatment of patients with Trigeminal neuralgia
Design
Clinical trial with intervention and control groups in two groups of 8 people, with parallel groups, two-way blind, randomized as an individual block, the random function of Excel software was used for randomization
The phase for this study does not apply
Settings and conduct
This trial was performed in patients referring to Al-Zahra Hospital affiliated to Isfahan University of Medical Sciences. Acupuncture was performed as a supplement to drug treatments. The intervention was performed on the main group and the placebo, which was the usual needles, was used to blind the control group.
Participants, researchers, outcome assessors, and analyzers are blinded.
Participants/Inclusion and exclusion criteria
A person with typical symptoms of Trigeminal neuralgia includes sudden, unilateral, shock-like pain in the path of the Trigeminal nerve branches
The person who with Trigeminal neuralgia undergoing drug treatment
Intervention groups
Perform acupuncture method in the intervention group
Use the usual needles in the control group and apply pressure to the skin
Main outcome variables
Patient pain according to VAS criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200704047996N1
Registration date:2020-07-25, 1399/05/04
Registration timing:retrospective
Last update:2020-07-25, 1399/05/04
Update count:0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
ali kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4264 8448
Email address
alikazemi_dnt@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2017-06-20, 1396/03/30
Trial completion date
2017-06-20, 1396/03/30
Scientific title
Evaluation of the therapeutic effect of Acupuncture as a complementary treatment in patients with Trigeminal neuralgia under medication treatment
Public title
Evaluation of the therapeutic effect of acupuncture as a complementary treatment in patients with trigeminal neuralgia under medication treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A person with typical symptoms of Trigeminal neuralgia includes sudden, unilateral, shock-like pain in the path of the Trigeminal nerve branches.
The person who with Trigeminal neuralgia undergoing drug treatment
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Actual sample size reached:
16
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants were blinded by contact of the needle with the skin as a placebo
Patients' names were given to the out of study operator,who were randomly divided persons into two groups and each individual was assigned a separate code and provided with clinical care.
After the intervention, the codes assigned to individuals In order to examine the consequences and the necessary analyzes, it was provided to the researcher and the evaluator of the consequence
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan Dental School, Hakim Nezami St.,
City
isfahan
Province
Isfehan
Postal code
8514694171
Approval date
2016-06-14, 1395/03/25
Ethics committee reference number
3556405
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
Patients' pain according to VAS criteria
Timepoint
Measurement of pain at the beginning of the study and after the end of the intervention after two weeks
Method of measurement
VAS criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to previous drug treatment acupuncture was given once a day for 3 times a week for at least 2 weeks. Acupuncture was performed by an anesthesiologist who is proficient in this Method. Thin, disposable sterile steel needles were used. The needles were held in the muscle until a tingling sensation, such as numbness or electric shock, was felt in the area, and then remained in place for 30 minutes.
Category
Treatment - Other
2
Description
Control group: Continue previous medication and use regular needles to apply pressure to the skin
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital of Medical Sciences, Isfahan
Full name of responsible person
iman mohamadi
Street address
Al-Zahra Hospital , Hakim Nezami St
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
shaghayegh haghjoo javanmard
Street address
Isfahan University of Medical Sciences , Hezar Jarib St.
City
isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3668 0048
Email
jazb@mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
alikazemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
oral and maxillofacial
Street address
Isfahan Dental School, Hakim Nezami St.,
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
alikazemi_dnt@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
alikazemi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
oral and maxillofacial
Street address
Isfahan Dental School, Hakim Nezami St.,
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
alikazemi_dnt@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
alikazemi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
oral and maxillofacial
Street address
Isfahan Dental School, Hakim Nezami St.,
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
alikazemi_dnt@yahoo.com
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
Not applicable
Informed Consent Form
No - There is not 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