Protocol summary

Summary
First study consisted of a methodological study is to evaluate the reliability of the information collected by the examiner performed on a sample of 20 cases. In the second part : changes in the thickness of the gluteus medius, quadratus Lumbarm, transves abdominis, multifidus muscles in 30 patients with chronic low back pain and 30 healthy women by the ultrasonography will be evaluated. In Part III study : women with chronic low back pain were randomly divided into two groups: the first group (control) received conventional therapy physiotherapy to reduce pain) TENS therapy(30 min) device with a frequency 100-80 Hz and short pulse time 50 ms and heating surface (plus trunk stabilization exercises, group II) test (routine physiotherapy treatment) similar to the first group (plus abductor exercises will receive lower limbs . after 8weeks( 3 times a week) will be evaluated by ultrasonography.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016081921459N3
Registration date: 2017-06-19, 1396/03/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-06-19, 1396/03/29
Registrant information
Name
Mohammad Akbari
Name of organization / entity
Dept. of Physical therapy, School of Rehabilitation,Iran University of Medical Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
akbari.mo@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of trunk stabilization and lower limb abductor muscles exercises impacts on thickness changes of the selected global and local lumbar and lower limb muscles and its association with the pain intensity and disability in women with chronic low back pa
Public title
Effect of exercise therapy on thickness change of lower limb musclles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with general health and age between 20 -45 years old. Exclusion criteria: si joint disorders; pregnant women and participants with a history of surgery in the lumbar spine; radiculopathy; persistent severe pain; neurological symptoms; osteoporosis; structural deformity; systemic inflammatory disease; previous spinal fusion; cardiovascular diseases; acute infection; recent abdominal surgery.
Age
From 20 years old to 45 years old
Gender
Female
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.IUMS.REC.1396.9223643201

Health conditions studied

1

Description of health condition studied
Chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain

Primary outcomes

1

Description
Thickness change
Timepoint
Before intervention, 8 weeeks after intervention
Method of measurement
Ultrasonography

Secondary outcomes

1

Description
Pain
Timepoint
Before intervention, 8 weeeks after intervention
Method of measurement
VAS

2

Description
Disability
Timepoint
Before intervention, 8 weeeks after intervention
Method of measurement
Quebec questionnaire

Intervention groups

1

Description
Routine physiotherapy treatment involves the use of device-TENS with frequency 80-100 Hz and surface heat and stabilization exercises, including muscle contraction multifidus and transverse abdomen in diferent positions ( supine, lateral positions and quadrapd position
Category
Treatment - Other

2

Description
Routine physical therapy treatment involves the use of device-TENS with frequency 80-100 Hz and surface heat plus abductor muscle strengthening exercises.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Jafar Pisheh
Street address
alzahra hospital, soffeh street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
farzaneh Jahani
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Akbari
Position
Ph.D
Other areas of specialty/work
Street address
School of Rehabilitation, Mirdamad St.
City
Tehran
Postal code
Phone
+98 21 2222 2059
Fax
Email
akbari.mo@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Akbari
Position
Ph.D
Other areas of specialty/work
Street address
School of Rehabilitation, Mirdamad St.
City
Tehran
Postal code
Phone
+98 21 2222 2059
Fax
Email
akbari.mo@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
IUMS
Full name of responsible person
mahnaz aboufazeli
Position
Ph.D candidate of physical therapy
Other areas of specialty/work
Street address
school of rehabilitation, blv mirdamad
City
tehran
Postal code
Phone
Fax
Email
m.fazel71062@gmail.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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