Protocol summary

Study aim
comparison of effictiveness of attention bias modification (ABM) with/without trance cranial direct current stimulation (TDCS) on attention bias, reduction of severity of perceived pain ,disability due to pain and depression in chronic low back pain patients.
Design
Participants randomly assign to experimental, control and placebo groups. The sample includes all of the low back pain patients between 20 and 50 years old who met the criteria for more than 3 months. Patients referring to Rofeideh hospital. The final sample size is 60.
Settings and conduct
Current study was conducted aiming at comparing attention bias modification with and without trance cranial direct current stimulation and its impact on reduction of pain and attention bias in patients with chronic low back pain at Rofideh Hospital. It is an experimental study with control and placebo group and two intervention groups. Blindness was achieved so that first the physician referred individuals to the examiner based on inclusion and exclusion criteria. The examiner performed required evaluations, and referred them to the therapist randomly. Following intervention, the subjects were referred to the second examiner in order to evaluate the outcomes. Thus, the physician, subjects, and outcome valuates were kept blind in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Age between 20 and 50 years. ability for writing and reading. low back pain more than 3 months. Exclusion criteria are: Substance and addictive disorder. psychiatric disorder( psychosis or bipolar disorder). migraine or recurrent headache. brain injury.
Intervention groups
One of the experimental groups receives attention bias modification task by computer through 5 sessions of 20 minutes and the other received the same combined with trance cranial direct current stimulation(tdcs). Control group fill questionnaires.Placebo group receive sham trance cranial direct current stimulation.
Main outcome variables
The primary outcomes are decrease in attention bias and severity of perceived pain. Secondary outcomes are the decrease of depression and disability due to pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171107037306N1
Registration date: 2017-12-17, 1396/09/26
Registration timing: prospective

Last update: 2017-12-17, 1396/09/26
Update count: 0
Registration date
2017-12-17, 1396/09/26
Registrant information
Name
yasaman shiasy
Name of organization / entity
The university of welfare and rehabilitation science.
Country
Iran (Islamic Republic of)
Phone
+98 88037571
Email address
ya.shiasy@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Some cost is paid by researcher and residual will be paid by Rofeideh hospital.
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of attention bias modification (ABM) with/without Trance cranial direct current stimulation (TDCS) on reduction of attention bias and severity of perceived pain in chronic low back pain patients.
Public title
Effectiveness of attention bias modification and Trance cranial direct current stimulation on reduction of pain and attention bias.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 50 years. ability for writing and reading. low back pain more than 3 months.
Exclusion criteria:
Substance and addictive disorder. Psychiatric disorder( psychosis or bipolar disorder). Migraine or recurrent headaches. Brain injury.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the subjects are randomly assigned into intervention, control, and placebo groups using random number table. Sealed non-transparent envelopes with random sequence were used to conceal random assignment. Following constructing random sequence by random table, 60 envelopes with aluminum wrappers (in order to obscure the envelopes) were prepared based on the research sample size, and each of random sequences was recorded on a card, and the cards were placed in the envelopes in order. External surface of the envelopes are numbered in the same order for preserving random sequence. Based on the order by which the qualified subjects entered to the study, the envelopes were opened and the assigned group for the subject was specified.
Blinding (investigator's opinion)
Double blinded
Blinding description
First, the physician interviewed with the patients considering inclusion and exclusion criteria. Then, individuals qualified with inclusion criteria, who were content with participation in the research, were introduced to the interviewer and he conducted the primary evaluation. The subjects were then referred to the therapist and were randomly assigned into the intervention or placebo groups. After intervention, the subjects were introduced to the examiner author, and secondary evaluation was carried out. Second examiner was unaware of assignment of subjects in intervention groups. Thus, the subjects, outcome valuator (second examiner), and clinical care provider were kept blind toward the group assignments in this study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of university of Social Welfare and Rehabilitation Sciences
Street address
Koodakyar Ave, Daneshjo Blvd ,Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2017-08-01, 1396/05/10
Ethics committee reference number
IR.USWR.REC.1396.47

Health conditions studied

1

Description of health condition studied
chronic low back pain
ICD-10 code
F45.4
ICD-10 code description
Pain disorders related to psychological factors.

Primary outcomes

1

Description
severity of perceived pain
Timepoint
Before intervention,one week after intervention,one month after intervention
Method of measurement
Visual analog scale- questionnaire of severity of chronic pain questinnaire.

2

Description
attention bais
Timepoint
Before intervention,one week after intervention,one month after intervention
Method of measurement
Dot probe test

Secondary outcomes

1

Description
Depression
Timepoint
Before intervention,one week after intervention,one month after intervention
Method of measurement
DASS questionnaire

2

Description
Disability due to pain
Timepoint
Before intervention,one week after intervention,one month after intervention
Method of measurement
Roland & Moris disability questionnaire

Intervention groups

1

Description
The second experimental group receive the attention bias modification task combined with trance cranial direct current stimulation through 5 sessions of 20 minutes.
Category
Rehabilitation

2

Description
placebo group receive sham Trance cranial direct current stimulation.(TDCS)
Category
Placebo

3

Description
One of the experimental groups receives attention bias modification task by computer through 5 sessions of 20 minutes .
Category
Rehabilitation

4

Description
control group answer the questionnaire and dont receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Rofeideh Rehabilitation Hospital
Full name of responsible person
Shima Shakiba
Street address
Nematy Ave, West Soleimany Ave, Gheitareh,Tehran
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 2220 5326
Fax
+98 21 2223 2741
Email
rofeideh.hospital@uswr.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rofeideh Rehabilitation Hospital
Full name of responsible person
Shima Shakiba
Street address
Nematy Ave, West Soleimany Ave, Gheitareh,
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 2220 5326
Fax
+98 21 2223 2741
Email
shimashakibash.psy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rofeideh Rehabilitation Hospital
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
Rofeideh Rehabilitation Hospital
Full name of responsible person
Shima Shakiba
Position
Supervisor of psychology ward in Rofeideh Hospital.
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Nematy Ave, Soleimany Ave, Gheitaerh
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 2223 3017
Fax
Email
shimashakibash.psy@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Yasaman Shiasy
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Koodakyar Ave, Daneshjo Blv, Evin, Tehan
City
Tehran
Province
Tehran
Postal code
1993696691
Phone
+98 21 8803 7571
Fax
Email
syasaman@rocketmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Yasaman Shiasy
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Koodakyar Ave, Daneshjo Blv, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1993696691
Phone
+98 21 8803 7571
Fax
Email
syasaman@rocketmail.com
Web page address

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
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Protocol of interventions including sessions’ description, the way of intervention, and system and software setting as well as number of the sessions will be published.
When the data will become available and for how long
Complete details of the protocol can be accessible after paper publication.
To whom data/document is available
All researcher working in academic and scientific institutes would be able to access the protocol.
Under which criteria data/document could be used
All researchers who will study the similar search or, need to this protocol for completing history can use the protocol.
From where data/document is obtainable
To receive the protocol send an email to this address: Syasaman@rocketmail.com( yasaman shiasy)
What processes are involved for a request to access data/document
To receive the protocol, first applicant send a curriculum vitae by email and explain aim of study. The items will check and then applicant will receive the answer in a week.
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