The effect of lumbosacral orthosis on pain, quality of life and temporo-spatial parameters of walking in the elderly with spondylolysis
Design
Prospective interventional study: Sampling of 10 people with spondylolysis will be done. First, each person without orthoslombosacral fills in the pain questionnaire while standing and the quality of life.
In the third stage, after 2 months of using orthoses and following up patients with a weekly phone call on how to close and how long to wear braces, re-evaluate the patient and after re-completing the questionnaires, the experiment will be performed with lumbosacral orthosis.
Settings and conduct
In this study, we consider 10 people as a preliminary and finally the exact number of samples will be calculated according to the results for future studies. Sampling among people with spondylolysis who are members of centers affiliated to Isfahan University of Medical Sciences; it is going to happen.
Eligible individuals are required to walk at a route of 13 meters in length and 3 meters in width at their chosen speed. Step by minute and step length and step time are measured.
Participants/Inclusion and exclusion criteria
Elderly 60 to 85 years; Spondylolysis in the 4th and 5th lumbar vertebrae; Have pain 4 days a week or more; Pain intensity should be at least 3 on the pain assessment scale; No history of drug use
Intervention groups
First, after completing the pain and quality of life questionnaire, each person first performs the test without orthoslombosacral. Then we fit the orthosis on the patient's body and perform the tests again. Finally, after 2 months of using orthoses and following up patients by phone, the patient will be re-evaluated weekly.
The effect of lumbosacral orthosis on pain, quality of life and spatiotemporal parameter of gait on elderly people with spondylolysis
Public title
The effect of lumbar belt on pain and gait in adolescent with lumbar pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly people aged 60 to 85 years who experience low back pain due to spondylolysis for at least 3 months
Spondylolysis in the 4th and 5th lumbar vertebrae
Have pain 4 days a week or more
Pain intensity at least 3 on the pain assessment scale
No history of use Medication
No sudden changes in pain
Exclusion criteria:
Spinal tumor
Progressive neurological disorder
Sensory disorders such as diabetes and neuropathy and ..
Lumbar surgery in the last 3 years
Age
From 60 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
No.318, Research and Technology Development Building, Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-10-02, 1400/07/10
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.129
Health conditions studied
1
Description of health condition studied
Spondylosis
ICD-10 code
M47
ICD-10 code description
Spondylosis
Primary outcomes
1
Description
Spatiotemporal parameter of gait on elderly people
Timepoint
Before, immediate and 2 months later
Method of measurement
Infrared cameras
Secondary outcomes
1
Description
Pain
Timepoint
Before, after and 2 months later
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
In the first stage, after completing the standing pain and quality of life questionnaire, each person first performs the test without orthoslombosacral. In the second step, we fit the orthosis on the patient's body and each person fills out the pain questionnaire while standing and performs the gait test with lumbosacral orthosis. In the third stage, after 2 months of using orthoses and following up patients with a weekly phone call on how to close and how long to wear braces, re-evaluate the patient and after re-completing the questionnaires, the experiment will be performed with lumbosacral orthosis.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Masoud Rafiaei
Street address
No 318, Rehabilitation college, Isfahan University of Medical Sciences, Hezarjerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Building No. 4, Vice Chancellor for Research and Technology, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
No. 318, Rehabilitation college
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
No318, Rehabilitation college
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Masoud Rafiaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
No. 318, Rehabilitation college
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5043
Email
ma.rafiaei@gmail.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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The effect of lumbosacral orthosis on pain,quality of life and spatiotemporal parameter of gait on elderly people with spondylolysis
When the data will become available and for how long
6 month
To whom data/document is available
article authors
Under which criteria data/document could be used
Analysis and verification
From where data/document is obtainable
The main performer
What processes are involved for a request to access data/document