The effect of trans cranial direct current stimulation on fear of pain in patients with low back pain
Design
tDCS is applied for 5 days. The scores of fear of pain and disability from low back pain disorder investigated immediately after applying tDCS in the first session and after 5 days.
Settings and conduct
Persons volunteering to participate in the project are invited to the Neuro muscular Rehabilitation Center of semnan University of Medical Sciences. At the time of the entry, the form containing information of plan and Informed consent, the personal profile and fear of pain and disability questionnaire are completed
Participants/Inclusion and exclusion criteria
inclusion criteria:
1-People who have back pain for at least 2 months ago,
2-People who have pain intensity less than 3
3-People who have score more than 30 in the pain anxiety symptom scale (PASS) questionnaire.
4- People with low back pain who had no history of physiotherapy
exclusion criteria:
1-People with vertebral fractures
2- People have lumbar spondilolisthesis vertebra higher than grade 2.
3-People who have defects in the sensory and motor nerves conduction of
4- People with headaches and neurological defects
Intervention groups
1) transcranial direct current stimulation on dorsolateral prefrontal area 2) transcranial direct current stimulation on SHAM
Main outcome variables
1-Fear of pain rate
2-Disability rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190311043012N2
Registration date:2019-06-27, 1398/04/06
Registration timing:registered_while_recruiting
Last update:2019-06-27, 1398/04/06
Update count:0
Registration date
2019-06-27, 1398/04/06
Registrant information
Name
pooran madani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3332 8502
Email address
pooran.madani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-10, 1398/02/20
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of stimulation on fear of pain in people with chronic low back pain with high fear
Public title
The effect of brain current stimulation on fear of pain in chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who have back pain for t least 2 months ago,
those who have pain intensity less than 3
People who have score more than 30 in the pain anxiety symptom scale (PASS) questionnaire.
People with low back pain who had no history of physiotherapy
Exclusion criteria:
People with vertebral fractures
have lumbar spondylolisthesis vertebra higher than grade 2
People who have defects in the speed of conduction of the sensory and motor nerves.
People with headaches and neurological defects.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization of random numbers that arranged as non-ordinating numbers in a table and read in the lower order.The names of people with the specified code are arranged in the table and these numbers are read from top to bottom of the table. The first 25 people in the intervention group and rest of them located in the sham group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The tDCS will be used on the control group participants from the beginning of the treatment session, but the duration of the current is only 30 seconds, and after disconnection of the electrical current, the electrodes remain on the respective brain regions for 20 minutes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Semnan University of Medical Science
Street address
Tabatabaee clinic,Mashahir squar,Ghods blvd
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2019-04-16, 1398/01/27
Ethics committee reference number
IR.SEMUMS.REC.1397.270
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
1-Fear of pain rate
Timepoint
At the beginning of the study, immediately and 5 days after the end of the intervention
Method of measurement
PASS (Pain Anxiety Symptom Scale)questionnaire
Secondary outcomes
1
Description
disability
Timepoint
before, immediately and 5 days after last session of intervention
Method of measurement
Roland Morris Disability questionnaire
Intervention groups
1
Description
Intervention group: trans cranial direct current stimulation with mA and 20 minutes on dorsolateral prefrontal in Consecutive 5 days
Category
Treatment - Devices
2
Description
Control group: Trans cranial direct current stimulation of the brain to trade off for 20 minutes ( The current there was only in the first 30 seconds)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Reaearch Center
Full name of responsible person
Dr. Rosita Hedayati
Street address
Faculty of Rehabilitation, Educational and therapeutic complex of Semnan university of medical sciences,5 km of Damghan road
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Fax
+98 23 3344 8999
Email
rozhed@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Rosita Hedayati
Street address
Faculty of Rehabilitation, Educational and therapeutic complex of Semnan university of medical sciences,5 km of Damghan roadan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 8996
Fax
+98 23 3344 8999
Email
President-offce@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?