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Effect of lumbosacral orthosis on thickness/cross-sectional area of trunk muscle stabilizers using ultrasound imaging in patients with low back pain

Protocol summary

Summary
Objective: To evaluate the effect of non-extensible lumbosacral orthosis on thickness/cross sectional area of trunk stabilizers muscles using ultrasound imaging in patients with non-specific chronic low back pain, Study design: A single-blinded randomized controlled trial, Population and sample size: Thirty four participants (20-55 years old) with chronic non-specific low back pain, for at least for 12 months, serious enough to require medical attention or absence from work. Intervention: participants will be randomized in to experimental or control group, both groups will receive 8 treatment sessions for a period of 4 weeks (twice a week). Common physiotherapy modalities will comprise of moist heat, ultrasound, TENS, posture and activity education, and flexibility exercises. Patients in the experimental group will be prescribed a non-extensible lumbosacral orthosis over the whole duration of the trial, and during the whole day, with the exception of bedroom and bathroom activities. Outcome measures: The primary outcomes include thickness of transverses abdominis and external oblique, and cross sectional area of lumbar multifidus that will be measured by ultrasound . Secondary outcomes are pain intensity, Oswestry Disability Index.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015083123836N1
Registration date: 2015-11-02, 1394/08/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-11-02, 1394/08/11
Registrant information
Name
Fatemeh Azadinia
Name of organization / entity
School of Rehabilitation, iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22228051
Email address
azadinia.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2015-11-06, 1394/08/15
Expected recruitment end date
2016-05-17, 1395/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lumbosacral orthosis on thickness/cross-sectional area of trunk muscle stabilizers using ultrasound imaging in patients with low back pain
Public title
Effect of orthosis on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
The subjects are included in LBP group if they meet the following criteria: age between 20 and 55 years, experience of back pain for at least for 12 months serious enough to require medical attention or absence from work, at least 1 episode of LBP in the last 6 month or pain with semicontinuous nature, no history of red flags, no history of core-strengthening exercise or physiotherapy and wearing orthosis during the past 6 month, no history of muscle relaxant medication, 3≤ VAS ≥7, ODI > 6. Individuals with a history of vestibular disorder, muscular dystrophy, neurological or sensory disorders, cardiac and respiratory disease, previous spinal surgery, serious neck problems, spinal structural deformity (kyphosis or scoliosis) , uncorrected vision impairment, vestibular disorder, pregnancy, diabetes, unequal length > 1 cm, osteoarthritis of hip and knee, BMI > 30, will be excluded. Also the subjects will be excluded if they have a hobby or job that requires extension of back or abdominal muscle training, a condition that requires prescription of muscle relax agents, or current use of analgesic medications other than acetaminophen (especially NSAD)
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 34
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
Hemmat Highway
City
Tehran
Postal code
Approval date
2015-08-30, 1394/06/08
Ethics committee reference number
IR.IUMS.rec.1394.26454

Health conditions studied

1

Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Loin pain Low back strain Lumbago NOS

Primary outcomes

1

Description
Thickness of Transversus abdominis and External oblique muscle
Timepoint
before & after 4 weeks intervention
Method of measurement
Ultrasound measurements, milimeter

2

Description
Cross-sectional area of multifidus
Timepoint
Before & after 4 weeks intervention
Method of measurement
Ultrasound measurements

Secondary outcomes

1

Description
Pain intensity
Timepoint
Before and after 4 weeks intervention
Method of measurement
Visual analogue scale

2

Description
Disability
Timepoint
Before & after 4 weeks intervention
Method of measurement
Oswestry Disability Index

Intervention groups

1

Description
Patients in the experimental group will be prescribed a non-extensible lumbosacral orthosis over the whole duration of the trial, and during the whole day, with the exception of bedroom and bathroom activities. Moreover they will receive 8 physical treatment sessions for a period of 4 weeks (twice a week). Common physiotherapy modalities will comprise of moist heat, ultrasound, TENS, posture and activity education, and flexibility exercises.
Category
Treatment - Other

2

Description
Patients in the control group will receive 8 physical treatment sessions for a period of 4 weeks (twice a week). Common physiotherapy modalities will comprise of moist heat, ultrasound, TENS, posture and activity education, and flexibility exercises.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation school, Iran University of Medical Sciences
Full name of responsible person
Fatemeh Azadinia
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Mossavi
Street address
Hemmat Highway, Iran University of medical Sciences
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
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Fatemeh Azadinia
Position
Ph.D candidate
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Postal code
Phone
+98 21 2222 8051
Fax
Email
azadinia.fatemeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Esmail Ebrahimi Takamjani
Position
PhD. in physical therapy
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Tehran
Postal code
Phone
+98 21 2222 9087
Fax
Email
ebrahimi.pt@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Fatemeh Azadinia
Position
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Nezam Alley, Shahnazari St. Madar Sq. Mirdamad Blv.
City
Postal code
Phone
+98 21 2222 8051
Fax
Email
azadinia.fatemeh@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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