Comparison the effect of motor control exercises and small muscles lumbar stretch with motor control exercises on postural stability indices, pain and disability in patients with chronic non-specific low back pain.
The aim of this study was to compare the effect of motor control exercises and small muscles lumbar stretch with motor control exercises on postural stability indices, pain and disability in patients with chronic non-specific low back pain.
Design
Randomized clinical trial, 30 patients with nonspecific chronic low back pain were selected through non probability sampling method.
Settings and conduct
This randomized controlled trial was performed at Zahedan university of medical sciences in 2018-2019 through simple sampling.
Participants/Inclusion and exclusion criteria
Inclusion criteria including: Age between 18 to 50 years; patients with non specific low back pain; no history of radicular pain and any neurologic sign, systemic infection, cardiovascular and balance disorders; not pregnant; no history of metabolic, systemic, inflammatory disease, arthritis and malignancies
Non-entry criteria including: history of spinal surgery and severe spinal deformity or disease; instability in the lumbar region; history of new fracture and lower limb injury.
Intervention groups
motor control exercises and small muscles lumbar stretch group and motor control exercises group.
Main outcome variables
Comparison of postural stability indices, pain and disability in motor control exercises and small muscles lumbar stretch group with motor control exercises group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090210001675N15
Registration date:2019-07-18, 1398/04/27
Registration timing:retrospective
Last update:2019-07-18, 1398/04/27
Update count:0
Registration date
2019-07-18, 1398/04/27
Registrant information
Name
Asghar Akbari
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1322 8445
Email address
akbaria@zdmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of motor control exercises and small muscles lumbar stretch with motor control exercises on postural stability indices, pain and disability in patients with chronic non-specific low back pain.
Public title
Comparison the effect of motor control exercises and small muscles lumbar stretch with motor control exercises in patients with chronic non-specific low back pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non specific low back pain for a period of at least 3 month.
Age between 18 to 50 years
No history of radicular pain and any neurologic sign, systemic infection, cardiovascular and balance disorders
Not pregnant
No history of metabolic, systemic, inflammatory disease, arthritis and malignancies
Exclusion criteria:
history of new fracture and lower limb injury
instability in the lumbar region
History of spinal surgery and severe spinal deformity or disease
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomly assigned into two groups by random draw. The first group received motor control exercises and small muscles lumbar stretch and the second group received motor control exercises
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
Ethics Committee of Zahedan University of Medical Sciences
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq. Zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816843463
Approval date
2019-01-27, 1397/11/07
Ethics committee reference number
IR.ZAUMS.REC.1397.410
Health conditions studied
1
Description of health condition studied
chronic non-specific low back pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified
Primary outcomes
1
Description
pain
Timepoint
before intervention and after intervention
Method of measurement
Visual Analogue Scale
2
Description
Functional disability
Timepoint
before intervention and after intervention
Method of measurement
Oswestry scale
3
Description
postural stability indices
Timepoint
before intervention and after intervention
Method of measurement
biodex balance system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: motor control exercises and small muscles lumbar stretch, eighteen training sessions during 6 consecutive weeks, three times per week, 30 or 40 minutes per sessions including: twenty minutes for receiving hot pack and TENS and 20 minutes for training and exercises.
Category
Rehabilitation
2
Description
Control group: motor control exercises, eighteen training sessions during 6 consecutive weeks, three times per week, 30 or 40 minutes per sessions including: twenty minutes for receiving hot pack and TENS and 20 minutes for training and exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Razmejo-Moghadam Physiotherapy Clinic
Full name of responsible person
Dr. Asghar Akbari
Street address
Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatoallah Kafami St.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
64855-98136
Phone
+98 54 3342 4675
Fax
+98 54 3342 4675
Email
akbari_as@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.noormohammad Bakhshani
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd, Dr.Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Fax
Email
a.akbari@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Asghar Akbari
Position
Ph.D in Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Dept. of Physiotherapy,School of Rehabilitation Sciences,Razmjejo-Moghadam Laboratory,Ayatoallah Kafami St.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816843463
Phone
+98 54 3342 4675
Email
akbari_as@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Asghar Akbari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Dept. of physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Labratory, Ayatollah kafami St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813664855
Phone
+98 54 3342 4675
Email
akbari_as@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
asghar akbari
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
dept. of physiotherapy, School of Rehabilitation Sciences, Razmejo-Moghadam Laboratory, Ayatollah Kafami St.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9813664855
Phone
+98 54 3342 4675
Email
akbari_as@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The whole data after making people unidentifiable can be shared.
When the data will become available and for how long
2 months after publication of the results.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
All whole data is available for researchers after making the participants unidentifiable, and any other analysis on the data and any use for research and therapeutic purposes is permitted in this study.
From where data/document is obtainable
Dr. Asghar Akbari. address: Dept. of Physiotherapy, School of Rehabilitation Sciences, Razmejo-moghadam Laboratory, Ayatollah Kafami St. City: Zahedan country: Iran Postal code: 9813664855 Tel:+985433424675 Fax: +985433424675 Email: abkari_as@yahoo.com
What processes are involved for a request to access data/document
After receiving the massage from the person requesting the application, and investigating the terms of the request the earliest opportunity is information required to be sent to the individual.