The effect of cognitive behavioral therapy (CBT) programs with cathodal DLPFC transcranial direct current stimulation on fear in patient with non-specific chronic low back pain with high fear
The effect of cognitive behavioral therapy(CBT) programs with cathodal DLPFC transcranial direct current stimulation on fear in patient with non-specific chronic low back pain with high fear
Design
In this research, 45 eligible patients with non-specific chronic low back pain referring to neuromuscular research of Semnan university of medical sciences will be chose purposefully and a code will be considered to each one of them. Then, patients will be randomly divided into 3 intervention, sham and control groups. All participants and assessor will be blind to group allocation.
Settings and conduct
Neuromuscular Rehabilitation Research Center Semnan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
45 patients with non-specific chronic low back pain referring to Neuromuscular Rehabilitation Research Center Semnan University of Medical Sciences.
Inclusion criteria: Age between 18-45; Having periodic low back pain for 12 weeks; Visual analog scale less than 3; Pain anxiety symptoms scale more than 30.
Exclusion criteria: Any symptoms of spinal cord involvement; Cauda equina syndrome symptoms; Sciatica symptoms; Root canal involvement symptoms; History of spinal surgery; Fracture in spinal column; Impairment of learning; Pregnancy.
Intervention groups
Intervention group: Receive 20 minutes cognitive behavioral therapy with cathodal transcranial direct current stimulation (tDCS). Sham intervention group: Receive 20 minutes cognitive behavioral therapy with 30 seconds cathodal tDCS. Control group: Receive only 20 minutes cognitive behavioral therapy. All groups received intervention for 8 sessions during 4 weeks.
Main outcome variables
Fear of pain, fear of movement, disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150302021294N6
Registration date:2018-02-07, 1396/11/18
Registration timing:registered_while_recruiting
Last update:2018-02-07, 1396/11/18
Update count:0
Registration date
2018-02-07, 1396/11/18
Registrant information
Name
Fatemeh Ehsani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
f.ehsani@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive behavioral therapy (CBT) programs with cathodal DLPFC transcranial direct current stimulation on fear in patient with non-specific chronic low back pain with high fear
Public title
The effect of cognitive behavioral therapy (CBT) programs with cathodal DLPFC transcranial direct current stimulation on fear in patient with non-specific chronic low back pain with high fear
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-45
Having periodic low back pain for 12 weeks
Visual analog scale less than 3
Pain anxiety symptoms scale more than 30
Exclusion criteria:
Any symptoms of spinal cord involvement
Cauda equina syndrome symptoms
Sciatica symptoms
Root canal involvement symptoms
History of spinal surgery
Fracture in spinal column
Impairment of learning
Pregnancy
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 3).
Using Excel software to generate random number tables.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in each group and assessors are blind to the experimental conditions and interventions (intervention group, sham group and control group).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Neuromuscular Rehabilitation research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
IR.SEMUMS.REC.1396.162
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
Score of fear in Pain Anxiety Symptoms Scale
Timepoint
Before interventions, immediately after intervention and 2 weeks after intervention
Method of measurement
Pain Anxiety Symptoms Scale to measure fear of pain
2
Description
Score of fear of movement in Tampa Scale for Kinesiophobia
Timepoint
Before intervention, immediately after intervention and 2 weeks later after intervention
Method of measurement
Tampa Scale for Kinesiophobia to measure fear of movement
3
Description
Disability
Timepoint
Before intervention, immediately after intervention and 2 weeks later after intervention
Method of measurement
Roland Morris questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Cognitive behavioral therapy with 20 minutes cathodal transcranial direct current stimulation on left DLPFC for 4 weeks, 2 sessions in each week
Category
Rehabilitation
2
Description
Intervention group 2: Cognitive behavioral therapy with 30 seconds cathodal transcranial direct current stimulation on left DLPFC for 4 weeks, 2 sessions in each week
Category
Placebo
3
Description
Control group: Cognitive behavioral therapy without transcranial direct current stimulation for 4 weeks, 2 sessions in each week
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Fax
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?