Protocol summary

Summary
The purpose of this study is to compare the effect of lumbar stabilization exercises with Mckenzie's exercises on lumbo-pelvic stability and transverse abdominis and multifidus muscles thickness in patients with non-specific chronic low back pain. This clinical trial will be performed at Tehran University of Medical Sciences, in 2012. Thirty patients with non-specific chronic low back pain will be selected through simple non-probability sampling. Inclusion criteria include: non-specific low back pain for a period of at least 3 months and resulted in dysfunction, chronic low back pain with or without referring to lower limb, and age between 18 and 50 years. Exclusion criteria include: recent fracture in lumbar, disc herniation, inflammatory diseases, spondylolisthesis or spondylolysis, malignancy, pregnancy, and exacerbation of symptoms (pain and disability) following exercise performance. Subjects are randomly assigned (random number sequence) to either the stabilization (N=15) or the Mckenzie's exercises group (N=15). Before and after intervention, pain (ordinal) through Visual Analogue Scale (VAS), lumbar lordosis (degree) with flexible ruler, range of lumbar flexion and extension (centimeter) using Modified-Modified Schober test, disability (ordinal) with The Functional Rating Index (FRI), lumbo-pelvic stability using pressure biofeedback, and transverse abdominis and multifidus thickness with ultrasonography will be assessed. Exercise program will be included eighteen sessions of exercise during 6 weeks, three times per week, and one hour per session for both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107197057N1
Registration date: 2012-08-24, 1391/06/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-08-24, 1391/06/03
Registrant information
Name
Mohammad Akbari
Name of organization / entity
ِDept. of Physical Therapy, School of Rehabilitation, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
akbari_mo@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2012-01-20, 1390/10/30
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the Effect of Lumbar Stabilization Exercises with Mckenzie's Exercises on Lumbo-Pelvic Stability and Transverse Abdominis and Multifidus Muscles Thickness in Patients with Non-Specific Chronic Low Back Pain.
Public title
The Effect of Lumbar Stabilization Exercises on Non-Specific Chronic Low Back Pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Non-specific low back pain for a period of at least 3 months and resulted in dysfunction; Chronic low back pain with or without referring to lower limb; and age between 18 and 50 years. Exclusion criteria: Recent fracture at lumbar; Disc herniation; Inflammatory diseases; Spondylolisthesis or spondylolysis; Malignancy; Pregnancy; Exacerbation of symptoms (pain and disability) following exercise performance.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
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
The Ethics Committee of Tehran University of Medical Sciences
Street address
Sixth Floor, Central Organization of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Postal code
Approval date
2012-01-18, 1390/10/28
Ethics committee reference number
90.d.130.2025

Health conditions studied

1

Description of health condition studied
Nonspecific chronic low back pain
ICD-10 code
M62.9
ICD-10 code description
Disorder of muscle, unspecified

Primary outcomes

1

Description
Low back pain
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
Visual Analogue Scale

2

Description
Disability
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
The Functional Rating Index

3

Description
Angle of lumbar lordosis
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
Flexible ruler

4

Description
Range of lumbar flexion and extension
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
Modified-Modified Shober Test

5

Description
Trasnsvers abdominis and multifidus muscles thickness
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
Ultrasonography

6

Description
Lumbo-pelvic stability
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
Pressure Biofeedback

Secondary outcomes

empty

Intervention groups

1

Description
Lumbar Stabilization Exercises: Eighteen sessions of exercise during 6 weeks, three times per week, and one hour per session
Category
Rehabilitation

2

Description
McKenzie's Exercises: Eighteen sessions of exercise during 6 weeks, three times per week, and one hour per session
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic, School of Rehabilitation Sciences
Full name of responsible person
Mohammad Akbari
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotuhi
Street address
Fourth Floor, Central Organization of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd., Tehran
City
Tehran
Grant name
بودجه پژوهشي
Grant code / Reference number
90/123700/07
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Akbari
Position
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran.
City
Tehran
Postal code
15459-13187
Phone
+98 21222280512
Fax
+98 21 2222 0946
Email
Akbari_mo@tums.ac.ir; Akbarimo43@yahoo.com
Web page address
www.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences.
Full name of responsible person
Mohammad Akbari
Position
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran.
City
Tehran
Postal code
15459-13187
Phone
+98 21222250812
Fax
+98 21 2222 0946
Email
Akbari_mo@tums.ac.ir; Akbarimo43@yahoo.com
Web page address
www.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Akbari
Position
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
School of Rehabilitation sciences, Nezam Alley, Shahnazari St., Madar Sq., Mirdamad Blvd., Tehran.
City
Tehran
Postal code
15459-13187
Phone
+98 21222280512
Fax
+98 21 2222 0946
Email
Akbari_mo@tums.ac.ir; Akbarimo43@yahoo.com
Web page address
www.tums.ac.ir

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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