Clinical trial of effects of transcranial direct current stimulation (TDCS) on pain intensity and disability level of patients with chronic non specific low back pain
The aim of this study is to determine the effect of transcranial direct current stimulation in patients with chronic mechanical low back pain is in both intervention and control groups. 35 people will be in each group randomly. None of the participants will know which groups is belonging to(one way blindness). Inclusion criteria include a history of mechanical low back pain in the last 3 months, older than 18 years and less than 55 years. All these patients are initially musculoskeletal examination. Then for the control and patient groups Celecoxib (anti-inflammatory inhibitor of COX2) at a dose of 100 mg daily starts. Transcranial direct current stimulation is used for patients by ENRAF device made in Netherlands also sham group using the same device (disable mode), then the results will be discussed in two groups. In every session the asesment will be done by pain intensity questionnaire (VAS) and disability questionnaire (OSWESTRY) will be completed by the patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015113025314N1
Registration date:2016-05-05, 1395/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
Samane Sedighi
Name of organization / entity
Aja University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8931
Email address
s84sedighi@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
501 Hospital of Aja University of Medical Sciences
Expected recruitment start date
2016-03-05, 1394/12/15
Expected recruitment end date
2017-03-05, 1395/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of effects of transcranial direct current stimulation (TDCS) on pain intensity and disability level of patients with chronic non specific low back pain
Public title
Effect of transcranial direct current stimulation on lowback pain
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: low back pain history for 3 months; age 18-55.
exclusion criteria: history of severe trauma to the low back; history of cancer; history of steroid use; severe weight loss; significant morning stiffness; signs of infection such as fever; night sweats; peripheral joint involvement; positive family history of rheumatic diseases; non-mechanical nature of pain (night pain, unrelated to activity); progressive muscle weakness; neurological defects; incontinence of urine and feces; evidence of spinal cord injury; radiculopathy; immunodeficiency disease; history of spinal surgery in the past year; neurodegenerative diseases; mental illness; pregnancy; dizziness; headaches; ear pain increased continuously.
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
blocking method is considered for randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Aja University of Medical Sciences
Street address
Etemadzade avenue,Fatemi street, Tehran
City
Tehran
Postal code
Approval date
2015-09-28, 1394/07/06
Ethics committee reference number
IR.AJAUMS.REC.1394.28
Health conditions studied
1
Description of health condition studied
MECHANICAL LOWBACK PAIN
ICD-10 code
M99.9
ICD-10 code description
Biomechanical lesion, unspecified
Primary outcomes
1
Description
disability intensity
Timepoint
before intervention, imidiatly after intervention, 1 month after intervention, 3 month intervention
Method of measurement
OSWESTRY quastionaire
2
Description
pain intensity
Timepoint
before intervention, imidiatly after intervention, 1 month after intervention, 3 month intervention
Method of measurement
VAS quastionaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: using Celecoxib capsule 100 mg daily and using tDCS device for 5 days, 20 minutes
Category
Treatment - Other
2
Description
control group: using Celecoxib capsule 100 mg daily and using sham status of tDCS device for 5 days, 20 minutes
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
501 aja hospital
Full name of responsible person
Behrouz tavana
Street address
Etemadzade avenue, Fatemi street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Aja University of Medical Sciences
Full name of responsible person
Behrouz Tavana
Street address
Etemadzade avenue, Fatemi street, Tehran
City
Tehran
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 of Aja University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
AJA university of Medical Sciences
Full name of responsible person
Samane Seddighi
Position
physical medicine and rehabilitation
Other areas of specialty/work
Street address
Etemadzade avenue, Fatemi street,Tehran, ,
City
Tehran
Postal code
Phone
+98 21 4382 3476
Fax
Email
s84sedighi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Aja University of Medical Sciences
Full name of responsible person
Samane Seddighi
Position
specialist in physical medicine and rehabilitation
Other areas of specialty/work
Street address
Etemadzade avenue, Fatemi street,Tehran
City
Tehran
Postal code
Phone
+98 21 4382 3476
Fax
Email
s84sedighi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Aja University of Medical Sciences
Full name of responsible person
Samane Seddighi
Position
Specialist in physical medicine and rehabilitation
Other areas of specialty/work
Street address
Etemadzade avenue, Fatemi street,Tehran
City
Tehran
Postal code
Phone
+98 21 4382 3476
Fax
Email
s84sedighi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)