Protocol summary

Summary
Background: Low back pain is a common musculoskeletal disorder with a high prevalence, so that 85% of the population may experience it. Core Stability exerciseshas been recommended to improve neuromuscular skeletal system function in order to increase the protection of vertebral column and improve functional activities. Methods: Sixty patients (aged 18 to 30 years old) with chronic low back pain are randomly assign in one of two general exercise (GE, n=30) and core stability (CS, n=30) groups of this clinical trial. The protocol of intervention include 4 weeks (3 sessions in week) of designed exercise in each groups. The functional activities are measure before and after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504154485N3
Registration date: 2015-05-02, 1394/02/12
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-02, 1394/02/12
Registrant information
Name
Abdolhamid Hajihasani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1444 1522
Email address
hajihasani@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2015-09-06, 1394/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on the effects of Core stability and General exercise on functional activity in non- specific low back pain patients
Public title
Efects of exercise therapy on activity in low back pain patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Non- specific low back pain patients; Aged 18 to 30 years old Exclusion Criteria: Neural. Skeletal, Muscular, cardiac, Vascular and Respiratory disease; Systematic disease; Spondylolssis and Spondylolystesis; Surgical treatment on Low back pain; Truma on Low back pain one week before intervention; Disc herniation; Polyneuropathy; Pregnancy
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Rehabilitation Faculty,Semnan University of Medical Sciences, 5 kilometers of Damghan road, Semnan. Iran
City
Semnan
Postal code
Approval date
2014-07-09, 1393/04/18
Ethics committee reference number
93.470218

Health conditions studied

1

Description of health condition studied
Low Back Pain
ICD-10 code
M62.6
ICD-10 code description
Muscle strain

Primary outcomes

1

Description
Test of balance
Timepoint
4 weeks after intervension
Method of measurement
Force plate set

Secondary outcomes

empty

Intervention groups

1

Description
General Exercise of Physiotherapy, include of Strengthenhng exercise in physiotherapy clinic
Category
Rehabilitation

2

Description
Core Stability Exercise, include of 8 specific exercises
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic of Tabatabai
Full name of responsible person
Elham Fatemi
Street address
Clinic of Physiotherapy, Ghods Street, Semnan, Iran
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Rashidipour
Street address
Semnan University of Medical Science,Basije Bulvard,Semnan, Iran
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
Abdolhamid Hajihasani
Position
PhD of Physiotherapy
Other areas of specialty/work
Street address
Rehabilitation Faculty,Semnan University of Medical Sciences 5 Kilometers of Damghan road, Semnsn, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
hajihasani41@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Abdolhamid Hajihasani
Position
PhD
Other areas of specialty/work
Street address
Rehabilitation Faculty,Semnan University of Medical Sciences 5 Kilometers of Damghan road, Semnsn, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
hajihasani41@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
Abdolhamid Hajihasani
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Rehabilitation Faculty,Semnan University of Medical Sciences 5 Kilometers of Damghan road, Semnsn, Iran
City
Semnan
Postal code
Phone
+233 3654180
Fax
Email
hajihasani41@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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