The present study aimed to investigate the effectiveness of transcranial direct current stimulation and pharmacotherapy on pain management in patients with chronic pain
Design
After sampling, the participants were assigned randomly via casting lots in three groups of experimental pharmacotherapy, tDCS, and control groups.
Settings and conduct
The present study followed a clinical trial design, with both the experimental and control groups and a pre-test, post-test, and follow up.
Participants/Inclusion and exclusion criteria
The statistical population consists of patients with chronic pain admitted to Pardis Multidisciplinary Pain Clinic, located in Tehran. The inclusion criteria were suffering from chronic pain, being female, the age range of 35 to 60 years, holding at least a school completion certificate, and being interested in participation in the intervention treatment. The exclusion criteria were suffering from severe psychological diseases in terms of diagnostic and statistical psychological disorder guidance (5th edition), which was diagnosed on the basis of the clinical interview.
Intervention groups
Pharmacotherapy
Transcranial Direct Current Stimulation (tDCS )
Main outcome variables
Pain Management
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211026052879N1
Registration date:2021-11-18, 1400/08/27
Registration timing:retrospective
Last update:2021-11-18, 1400/08/27
Update count:0
Registration date
2021-11-18, 1400/08/27
Registrant information
Name
Atefeh Lotfi Jabali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7650 5891
Email address
atlotfi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
2011-06-22, 1390/04/01
Actual recruitment end date
2020-08-22, 1399/06/01
Trial completion date
2020-12-21, 1399/10/01
Scientific title
Effectiveness of Transcranial Direct Current Stimulation and Pharmacotherapy on Pain Management in Patients with Chronic Pain
Public title
tDCS and Pharmacotherapy on Pain Management in Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from chronic pain
Being female
Age range of 35 to 60 years
Holding at least a school completion certificate
being interested in participation in the intervention treatment
Exclusion criteria:
Suffering from severe psychological diseases in terms of diagnostic and statistical psychological disorder guidance
Age
From 35 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were divided into experimental and control groups based on a table of random numbers, so that odd numbers were considered for the experimental group and even numbers were considered for the control group. As a result, participants were assigned to experimental and control groups according to the type of random number they received.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee, Islamic Azad University, Roudehen, Iran.
Street address
Islamic Azad University, Roudehen, Iran.
City
Tehran
Province
Tehran
Postal code
3973188981
Approval date
2020-05-26, 1399/03/06
Ethics committee reference number
1134820005987911399162344200
Health conditions studied
1
Description of health condition studied
Chronic Pain
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Pain management
Timepoint
Post-test
Method of measurement
The McGill Pain Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pharmacotherapy: Pharmacotherapy involved taking 600 mg of gabapentin twice a day (300 mg in the morning and 300 mg at night) for three weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Transcranial Direct Current Stimulation: tDCS involved increasing the delta waves (0.5-3 Hz) to raise endorphins and, therefore, alleviate pain and promote a sense of peacefulness. All the participants in the tDCS group received 20 minutes of delta wave at a 2µA current for 10 weeks straight (one month). Anode and cathode electrodes were placed on the frontal C3 and FP2 regions, respectively. Every 20-minute session started upon connecting the ear clips and automatically ended after a certain time elapsed. At the end of the 10th week, the participants were no longer allowed to continue treatment or receive any type of tDCS.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Pardis Pain Clinic (Tehran)
Full name of responsible person
Atefeh Lotfi Jabali
Street address
Saadat Abad, Bakhshaish St.,
City
Tehran
Province
Tehran
Postal code
1446665657
Phone
+98 21 2238 3662
Email
atlotfi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Roudehen Branch, Islamic Azad University
Full name of responsible person
Malek Mirhashemi
Street address
Roudehen Branch, Islamic Azad University
City
Tehran
Province
Tehran
Postal code
3973188981
Phone
+98 21 7650 5015
Email
info@riau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research, Roudehen Branch, Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Atefeh Lotfi Jabali
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Roudehen, Iran.
City
Roudehen
Province
Tehran
Postal code
3973188981
Phone
+98 21 7650 5015
Email
atlotfi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Atefeh Lotfi Jabali
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Roudehen, Iran.
City
Tehran
Province
Tehran
Postal code
3973188981
Phone
+98 21 7650 5015
Email
atlotfi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Atefeh Lotfi Jabali
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Psychology, Roudehen Branch, Islamic Azad University, Roudehen, Iran.
City
Tehran
Province
Tehran
Postal code
3973188981
Phone
+98 21 7650 5891
Fax
Email
atlotfi@yahoo.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
Ethical considerations and privacy of participants