Effect of whole body vibration on trunk proprioception in non-specific chronic low back pain
Design
Clinical trial with control group; Randomized, without placebo, single center trial.
Settings and conduct
60 patients with non-specific chronic low back pain who referred to Neuro muscular rehabilitation research center of Semnan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 40 to 70 years; Diagnosis of non-specific chronic low back pain (without showing neurologic defect); Having non-specific chronic low back pain for at least 6 months.
Exclusion criteria: Chronic low back pain with known etiology; Any other major illness; Regular physical activity (more than once a week) during 5 years ago; Use of any medication that may have significantly affect the balance; Diabetes; High blood pressure; Persons that perform a regular strength exercises; The presence of metal in the body, Having cardiovascular disease.
Intervention groups
Intervention group: In this group, the patients stand on Scott's position on a vibrations platform without shoes, while the feet are spaced from about 33 cm. The flexion angle of the knee measured by the goniometer. In this situation, the vibration is performed according to the protocol (24 sessions, a total of 12 weeks and 2 times in a week with a minimum of one day interval). All measurements are performed and evaluated before and 12 weeks after the intervention.
Control group: In this group, the patients stand on Scott's position on a vibrations platform without shoes, while the feet are spaced from about 33 cm, the difference is that the machine is off. There is no therapeutic treatment and only for comparison with the intervention group.
Main outcome variables
Deep feeling (Trunk Reposition Error (TRE))
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N34
Registration date:2018-08-12, 1397/05/21
Registration timing:registered_while_recruiting
Last update:2018-08-12, 1397/05/21
Update count:0
Registration date
2018-08-12, 1397/05/21
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-06, 1396/11/17
Expected recruitment end date
2019-02-06, 1397/11/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of whole body vibration on trunk proprioception in non-specific chronic low back pain
Public title
Effect of whole body vibration on trunk proprioception in non-specific chronic low back pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 40 to 70 years
Diagnosis of non-specific chronic low back pain (without showing neurologic defect)
Having non-specific chronic low back pain for at least 6 months
Exclusion criteria:
Chronic low back pain with known etiology
Any other major illness
Regular physical activity (more than once a week) during 5 years ago
Use of any medication that may have significantly affect the balance
Diabetes
High blood pressure
Persons that perform a regular strength exercises
The presence of metal in the body
Having cardiovascular disease
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers is used for randomization. Using Excel software to generate random number tables.
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2018-02-06, 1396/11/17
Ethics committee reference number
IR.SEMUMS.REC.1396.220
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
Deep feeling (Trunk Reposition Error (TRE))
Timepoint
Before and 12 weeks after intervention
Method of measurement
Dualer IQ™ digital Inclinometer (J-TECH medical, Salt Lake City, UT, USA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, the patients stand on Scott's position on a vibrations platform without shoes, while the feet are spaced from about 33 cm. The flexion angle of the knee measured by the goniometer. In this situation, the vibration is performed according to the protocol (24 sessions, a total of 12 weeks and 2 times in a week with a minimum of one day interval). All measurements are performed and evaluated before and 12 weeks after the intervention.
Category
Treatment - Other
2
Description
Control group: In this group, the patients stand on Scott's position on a vibrations platform without shoes, while the feet are spaced from about 33 cm, the difference is that the machine is off. There is no therapeutic treatment and only for comparison with the intervention group.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Atefe Aminianfar
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefeh Aminianfar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Hojati
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Atefe Aminianfar. Neuromuscular Rehabilitation Research Center, Ghods Blvd. 00989122132947
What processes are involved for a request to access data/document