The effect of mindfulness based cognitive therapy in addition to stability exercise on disability, fear avoidance beliefs and the thickness of multifidus muscle in the subjects with non specific low back pain
The aim of this study is the effect of mindfulness based cognitive therapy in addition to stability exercise on disability, fear avoidance beliefs and the thickness of multifidus muscle in the subjects with non specific low back pain
Design
The clinical trial with control group, parallel group with 40 patients, randomized
Settings and conduct
40 volunteers with non specific low back pain will be randomly assigned to two intervention group including stability exercise and stability exercise with mindfulness based cognitive therapy
Participants/Inclusion and exclusion criteria
The main inclusion criteria are volunteers aged between 18 and 45 years old and visual analog scale below 4 with non specific low back pain who will be referred to Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences
The main exclusion criteria are any systemic diseases, acute musculoskeletal disorders and psychopathy
Intervention groups
Stability exercise will be applied for control group in 3 sessions per week during 8 weeks and stability exercise with mindfulness based cognitive therapy for intervention group in 2 sessions per week during 8 weeks
Main outcome variables
Disability, fear avoidance beliefs and the thickness of multifidus muscle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150602022539N8
Registration date:2018-05-27, 1397/03/06
Registration timing:registered_while_recruiting
Last update:2018-05-27, 1397/03/06
Update count:0
Registration date
2018-05-27, 1397/03/06
Registrant information
Name
Ziaeddin Safavi Farokhi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
zsafavi@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2018-05-19, 1397/02/29
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness based cognitive therapy in addition to stability exercise on disability, fear avoidance beliefs and the thickness of multifidus muscle in the subjects with non specific low back pain
Public title
The effect of mindfulness based cognitive therapy in addition to stability exercise in low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteers aged between 18 and 45 years old
Visual analog scale below 4
Unilateral or bilateral pain in lumbar area that lasted more than 3 months
Exclusion criteria:
Unwillingness to participate in the project
The history of neurological diseases; infection; systemic diseases; surgery of lumbar region; any radicular pain to lower limbs
Any structural deformity such as Scoliosis and vertebral bone fracture
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Permuted block randomization
Randomization unit: Person
Stratified randomization: Not done
Randomization instrument: ٌRandom allocation software (Excel)
Random sequence generation: Used random blocks, each block containing 4 people and allocated a number from 1 to 6 to each block
Allocation concealment: Because of physiotherapy interventions for patients, allocation concealment is not possible
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
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
5319899951
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
IR.SEMUMS.REC.1396.111
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
Disability
Timepoint
Before and immediately after intervention
Method of measurement
Oswestry disability index questionnaire
2
Description
Fear avoidance beliefs
Timepoint
Before and immediately after intervention
Method of measurement
Fear avoidance behavior questionnaire
3
Description
Thickness of multifidus muscle
Timepoint
Before and immediately after intervention
Method of measurement
Millimeter by ultrasonography device
Secondary outcomes
1
Description
Fear of movement
Timepoint
Before and immediately after intervention
Method of measurement
Tampa scale for kinesiophobia questionnaire
2
Description
Cognitive beliefs
Timepoint
Before and immediately after intervention
Method of measurement
Cognitive questionnaire
Intervention groups
1
Description
In the control group stability exercise will be applied in 3 sessions per week during 8 weeks for 20 patient. Lumbar stability exercise will be done 45 minutes per session. The control group will not receive any psychological intervention.
Category
Rehabilitation
2
Description
In the intervention group stability exercise and mindfulness cognitive therapy will be applied in 2 sessions per week during 8 weeks for 20 patient . Mindfulness cognitive therapy will be applied before stability exercise and each intervention will be done 45 minutes per session. The mindfulness cognitive therapy will be done by a psychologist for intervention group and it will be done based on a specific treatment protocol for 8 sessions. The basis of this treatment is relaxation. The focus of this program is on awareness enhancement, attention to cognitive and emotional factors and behavioral activation finally.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Street address
Mashahir Square, in front of Helal Ahmar, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Email
ziasafavi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidipour
Street address
Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
ziasafavi@yahoo.com
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, Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Fax
Email
ziasafavi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Fax
Email
ziasafavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Rehabilitation faculty, Semnan University of Medical Sciences, Kilometer 5 of Damghan Road, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Fax
Email
ziasafavi@yahoo.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
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