Protocol summary

Summary
The aim of present study is to examine McGill stabilization and General lumbar exercises on center of pressure and balance variables changes and lumbar range of motion and pain in chronic non-spesific low back pain(CNSLBP). study population consists of 30 CNSLBP patients aged 20-40 years. Patients will be randomly divided into two groups : Control group will take general lumbar exercises and intervention group will take McGill stabilization exercises. Each patient will treat for six weeks. Study variables including pain intensity, range of motion, center of pressure variables, and postural balance which will be measured for each three weeks and will be followed up after one month.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015051022202N1
Registration date: 2016-05-01, 1395/02/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-01, 1395/02/12
Registrant information
Name
Mir Ali Eteraf Oskoei
Name of organization / entity
Rehabilitayion Faculty, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 4647
Email address
eterafoskouei@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-12-11, 1394/09/20
Expected recruitment end date
2016-03-10, 1394/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lumbar McGill stabilization and general exercises on spinal postural balance, pain and active range of motion in patients with non-specific chronic low back pain; Clinical Trial
Public title
Effect of lumbar McGill stabilization and general exercises on spinal postural balance, pain and active range of motion in patients with non-specific chronic low back pain; Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
In this study, two groups of men and women with nonspecific low back pain will participate. Inclusion criteria : Men and women with an average age of 20-40 years; Body Mass Index(BMI) between 20-25; non-specific low back pain with no specific cause and pain for more than six months without referal pain in the lower extremities; non-specific low back pain of less than 4 from 10 in patients with using Visual Analogue Scale Pain(VAS); did not receive physiotherapy treatment programs Exclusion criteria: having surgeries in the spinal vertebarl, abdominal, shoulder gridle, pelvic gridle, and lower extremities; obvious postural malalignment or muscle shortenings; the arms and legs pain or weakness; repeated Neurologic deficits; having a history of medical diseases and cardiovascular diseases; professional athletes; use of drugs that affect the balance; In women, married and pregnant
Age
To 40 years old
Gender
Both
Phase
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization with random-number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht , Tabriz
City
Tabriz
Postal code
Approval date
2015-02-09, 1393/11/20
Ethics committee reference number
93170

Health conditions studied

1

Description of health condition studied
Non-specific Chronic Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low Back Pain

Primary outcomes

1

Description
Center of Pressure variables
Timepoint
Three times in the six weeks of the study and after one month
Method of measurement
FDM Zebris

2

Description
Balance index
Timepoint
before - after
Method of measurement
Biodex system

Secondary outcomes

1

Description
Range of motion
Timepoint
Three times in the six weeks of the study and after one month
Method of measurement
Inclinometer

2

Description
Pain
Timepoint
Three times in the six weeks of the study and after one month
Method of measurement
Visual Analoge Scale

Intervention groups

1

Description
Intervention group, lumbar McGill stabilization exercises
Category
Rehabilitation

2

Description
Control group, lumbar general exercises
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic of Faculty of Rehabilitation
Full name of responsible person
Mir Ali Eteraf Oskouei
Street address
Faculty of Rehabilitation, Golpark, North Tavanir, Valyeasr, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mir Ali Eteraf Oskouei
Street address
Rehabilitation Faculty, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Rehabilitayion Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Eteraf Oskouei, Mir Ali
Position
Associate Professor - Physiotherapy PhD
Other areas of specialty/work
Street address
Rehabilitayion Faculty, Golpark, North Tavanir, Valyeasr, Tabriz
City
Tabriz
Postal code
5157635411
Phone
+98 41 3333 4647
Fax
Email
eterafoskouei@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rehabilitayion Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Eteraf Oskoei, Mir Ali
Position
Associate Professor
Other areas of specialty/work
Street address
Rehabilitayion Faculty, Golpark, North Tavanir, Valyeasr, Tabriz
City
Tabriz
Postal code
5157635411
Phone
+98 41 3333 4647
Fax
Email
eterafoskouei@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rehabilitation Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Eteraf Oskouei, Mir Ali
Position
Associate Professor
Other areas of specialty/work
Street address
Rehabilitation Faculty, Tabriz, Golpark, North Tavanir, Valyeasr, Tabriz
City
Tabriz
Postal code
5157635411
Phone
+98 41 3333 4647
Fax
Email
eterafoskouei@tbzmed.ac.ir
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
Loading...