Comparison of the effect of balance practice and stability exercises on kinetic factors of balance, pain intensity and disability in patients with non-specific chronic low back pain
Comparison of the effect of balance practice and stability exercises on kinetic factors of balance, pain intensity and disability in patients with non-specific chronic low back pain
Design
Clinical trial with 3 parallel groups, single-blind, randomized, phase 3 on 60 patients. use roll ofdie method for randomization.
Settings and conduct
People are randomly divided into 3 groups (1- stability exercises, 2- balance exercises, 3- control).At the beginning and end of the study We measure the following variables
, to check the balance ( displacement of the center of pressure and the time to reach stability by force plate - time in the Stork test - distance in Star test), to check pain (score of vas) to check disabilityare (score of oswestery), finally the comparison between groups and within groups ،will be made. Studies are conducted at Semnan Neuromuscular Rehabilitation Research Center
Participants/Inclusion and exclusion criteria
inclution criteria :Patients who have been diagnosed as non-specific back pain with or without referring pain to the leg that lasts at least three months. The pain intensity should be at least 3 according to the pain questionnaire, their age should be between 20 and 60 years.
Exclution criteria:- pregnancy-History of back surgery- Cancer- Vestibular problems- Neurological problems - pathology in the spin- Nerve root disorders- Vertebral fracture- ankle or knee Arthritis Congenital foot and ankle deformities - Ankle sprains, knee and leg ligament injuries
Intervention groups
Group 1: clinical exercises (6 weeks-3 times a week) Group 2:stabilityexercises (6 weeks-3 times a week)Group 3: no exercise
Main outcome variables
Fluctuations of the center of pressure - time to stability - time in the Stork test - distance in Star test - the score of VAS - the score of oswestry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230612058468N1
Registration date:2023-08-19, 1402/05/28
Registration timing:registered_while_recruiting
Last update:2023-08-19, 1402/05/28
Update count:0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
susan shahhosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8839 2182
Email address
shahhosseiniali@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2023-09-17, 1402/06/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of balance practice and stability exercises on kinetic factors of balance, pain intensity and disability in patients with non-specific chronic low back pain
Public title
Comparison of the effect of balance practice and stability exercises on kinetic factors of balance, pain intensity and disability in patients with non-specific chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been diagnosed as non-specific back pain with or without referring pain to the leg that lasts at least three months. .
The pain intensity should be at least 3 according to the pain questionnaire
their age should be between 20 and 60 years
Exclusion criteria:
People who are pregnant .
People who have a history of back surgery.
People who have cancer.
People who have vestibular system problems.
People who have neurological problems.
People who have pathology in the spinal cord.
People who have nerve root disorders .
People who have fractured vertebra.
People who have arthritis in the ankle or knee.
People who have congenital deformities of the foot and wrist such as genovalgum genovarum genu recuratum.
People who have ankle sprains And those who have knee and leg ligament injuries.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Individual randomization unit
Dice randomization tool
How to make a random sequence: In this study, there are three groups. Numbers 1-2 are used for the first group, numbers 3-4 are used for the second group, and numbers 5-6 are used for the third group.
Concealment using non-transparent sealed envelopes: based on the sample size, a number of envelopes are prepared and each of the random sequences created is recorded on the card, and the card is placed inside the envelope and the lid of the envelopes is glued and It is placed in the box, according to the order of arrival of the participants, one of the envelopes is opened and the participating group is revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient does not know which of the research groups he/she is placed in, so our study is single blinded
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
No29, east 4th ave, seyed jamaledin asad abadi , tehran town
City
Tehran
Province
Tehran
Postal code
1431684316
Approval date
2023-06-25, 1402/04/04
Ethics committee reference number
IR.SEMUMS.REC.1402.039
Health conditions studied
1
Description of health condition studied
non-specific low back pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
evaluation of static balance by measuring time during standing stork test - evaluation of static balance by measuring the speed of changes in the center of pressure -evaluation of static balance by measuring the displacement of changes in the center of pressure .
Timepoint
Before the intervention and 1 week after the end of the intervention
evaluation of dynamic balance by measuring the covered distance during Star excursion balance test - evaluation of dynamic balance by measuring time to stability .
Timepoint
Before the intervention and 1 week after the end of the intervention
Method of measurement
Dynamic balance checking tool: Force plate. Dynamic balance checking tool: Star excursion balance Test.
3
Description
Examining the level of pain through the visual analogue scale's scores.
Timepoint
Before the intervention and 1 week after the end of the intervention
Method of measurement
Pain assessment tool: Visual analogue Scale.
4
Description
- Examining the level of disability through the oswestry disability questionnaire's scores.
Timepoint
Before the intervention and 1 week after the end of the intervention
Intervention group: Intervention group 1 is a group that receives balance exercises that include eleven exercises for 60 minutes (15 minutes of warming up - 15 minutes of cooling down - 30 minutes of main exercise), .three times a week for 6 weeks .
Category
Rehabilitation
2
Description
Control group: They do not receive any treatment, only the studied variables are measured for them once at the beginning of the study and once at the end of the study and compared with the other groups.
Category
N/A
3
Description
Intervention group: is a group that receives stability exercises that include eight exercises for 60 minutes (15 minutes of warm-up - 15 minutes of cooling down - 30 minutes of main exercise), three times a week for 6 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan
Full name of responsible person
Banafsheh Mansori
Street address
Neuromuscular Rehabilitation Research Center of Semnan,Tabatabayi Clinic,next to Nemat Ice Cream ,Ghods Blvd,Semnan Town
City
Semnan
Province
Semnan
Postal code
9837535196
Phone
+98 23 3332 8502
Fax
+98 23 3365 4180
Email
nmrrc@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
kamran Qods
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3345 2199
Fax
+98 23 3344 8999
Email
info@semums.ac.ir
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
Susan Shahhosseini
Position
Student-master degree
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.29 4th street chehelsotoon ave . jahad square .teheran town
City
Teheran
Province
Tehran
Postal code
1431684316
Phone
+98 21 8839 2182
Fax
Email
shahhosseiniali@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
رزیتا هدایتی
Position
Associate Professor of Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
1431684316
Phone
+98 23 3332 8502
Fax
Email
hedayati@semums.ac.ircom
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Susan Shahhosseini
Position
Student-master degree
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.29 4th street chehelsotoon ave . jahad square .teheran town
City
Teheran
Province
Tehran
Postal code
1431684316
Phone
+98 21 8839 2182
Fax
Email
shahhosseiniali@ymail.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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after de-identifying individuals, including: background information. The amount of changes in the center of pressure - the amount of changes in the time to reach stability - the amount of changes in the distance traveled in the Star test - the amount of changes in the time in the Stork test - the amount of changes in the score of the visual scale analogue - the amount of changes in the score of the oswestry questionnaire
When the data will become available and for how long
One month after publication
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions, and people working in industry can apply to receive them
Under which criteria data/document could be used
Students who are doing a research and people working in the field of treatment
From where data/document is obtainable
Sosan Shah Hosseini- Phone: 09121243936 Email: shahhosseinisousan@gmai.com
What processes are involved for a request to access data/document
The request and its reason should be registered via e-mail and the data will be sent within five working days