The study of effective of cognitive behavior fear management with stabilization exercise on automatic and voluntary activity of muscles in people with non-specific chronic low back pain
Main objective is evaluation of effetive of cognitive behaviour fear management with stabilization exercise on automatic and voluntary activity of muscles in people with non-specific chronic low back pain. This study is a double blinded randomized control trial. Subject with non-specific chronic low back pain of at least 3 mounths duration were randomly assigned to 8 weekly treatments with core stability exercise and cognitive bahavior fear management in groups. Subject will excluded if they have neourological signs from nerve root compression, former back surgery, pregnancy and unsolved social security. Variables are automatic and voluntary activity of abdominal muscles, pain, fear and disability. Testing will be performed prior to intervention and 8 weeks after intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020716514N1
Registration date:2014-05-31, 1393/03/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-31, 1393/03/10
Registrant information
Name
Nasim Hemati Broujeni
Name of organization / entity
Semnan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 1444 0225
Email address
nhemati@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University ofMedical Sciences
Expected recruitment start date
2014-03-01, 1392/12/10
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of effective of cognitive behavior fear management with stabilization exercise on automatic and voluntary activity of muscles in people with non-specific chronic low back pain
Public title
Effect of cognitive behavior fear management on people with non-specific chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female with non-specific chronic low back pain for 3 months or more; and pain score of 3 or less on a visual analoge scale.
Exclusion criteria: female with neurological signs; breathing problem; arthrities, systemic and metabolic disease; infection; spinal malalignment; former back surgery; pregnancy; vertebral fracture; acute truma; using opiods; unsolved social security.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 science
Street address
Vice chancellor for research, Semnan University of Medical Science, Basij Blvd
City
Semnan
Postal code
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
92/415444
Health conditions studied
1
Description of health condition studied
non-specific chronic low back pain
ICD-10 code
M95, M96,
ICD-10 code description
disorders of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
Automatic activity of muscles
Timepoint
before intervention, 8weeks after interventions
Method of measurement
ultrasound
2
Description
muscle activation
Timepoint
before intervention, 8weeks after interventions
Method of measurement
ultrasound
Secondary outcomes
1
Description
pain
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
visual analoge scale
2
Description
fear of pain
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
Tampa Scale for Kinesiophobia
3
Description
disability
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
Roland and Morris
4
Description
fear of movement
Timepoint
before intervention, 8 weeks after intervention
Method of measurement
Fear Avoidance Belief Questionare
Intervention groups
1
Description
cognotive behavioral therapy is intervention. cognitive behavioral therapy involves a combination of cognitive and behavioral techniques and is based on the assumption that the individual's way of thinking and affects behavior and emotions. in this cases the idea is to target maladaptive thoughts and behaviors usingstructured technique that aim to identify, challenge, and subsequently change patterns of unhelpful thoughts and behaviors. It gives to pateint once a week for 8 weeks by spesking to pateint.
Category
Behavior
2
Description
core stabilization exercise: the target of these exercise is improvment of muscles activation and increase coordination of those and reduce the copression pressur between joints.
it gives 3 times on the week for 8 weeks by therapists
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center, Semnan Universityof Medical Science
Full name of responsible person
Nasim Hemati Boroujeni
Street address
Mashahir squar
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Raheb Ghorbani
Street address
Vice chancellor for research, Semnan University of Medical Science, Basij Blvd.,
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Nasim Hemati Broujeni
Position
MSc student in Physical Therapy
Other areas of specialty/work
Street address
unit 1, code 29, Pirouz alley, up to SeidKhandan bridge, Shariati st, Tehran
City
Tehran
Postal code
1661739634
Phone
+98 21 2287 0910
Fax
Email
nasimhb@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Rosita Hedayati
Position
PhD in Physical Therapy
Other areas of specialty/work
Street address
Vice chancellor for research, Semnan University of Medical Science, Basij Blvd.,
City
Semnan
Postal code
Phone
+98 23 1444 0225
Fax
Email
rosehed@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
Nasim Hemati Broujeni
Position
MSc student in physical therapy
Other areas of specialty/work
Street address
unit 11, code 29, Pirouz alley, up to Seid Khandan bridge, Shariati st, Tehran
City
Tehran
Postal code
Phone
+98 21 2287 0910
Fax
Email
nasimhb@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)