Protocol summary

Study aim
The Effect of Eight weeks Aqua Stretch and Dynamic Neuro Muscular Stabilization on Pain, Disability and foot pressure distribution in Patients with Nonspecific Chronic Low Back Pain
Design
Random controlled trial, with control group, with parallel, two-way blind groups
Settings and conduct
The study, conducted at Razi University's Sports Rehabilitation Laboratory, will evaluate the randomized double-blind, double-blind, 52-year-old patients with non-specific chronic low back pain.Then, in three groups, dynamic neuromuscular exercises, aqua sterch and control will be included. After the intervention, the evaluations will be done again
Participants/Inclusion and exclusion criteria
Age 30 to 50 years with chronic non-specific low back pain for three months or more and OSWESTRY score of 20 to 61, visual acuity pain (VAS) between 3 and 8, no surgical intervention, no damage, especially in Low back pain, lack of pregnancy, lack of exercise therapy at least 6 months before the study. Also, people with bone fractures, duct stenosis, vertebral fractures, a history of back surgery, inflammatory joint disease during pregnancy or less than 6 months after delivery
Intervention groups
Group 1: Dynamic neuromuscular stabilization exercises for 8 weeks and 3 sessions per week Group 2: َAqua stretching exercises for eight weeks and 3 sessions per week Third group: control group that Receive correct and preventive posture training on spine pressure online in cyberspace.
Main outcome variables
Pain and disability, center of pressure,balance,lumbopelvic control, spinal posture

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200704048002N1
Registration date: 2020-08-03, 1399/05/13
Registration timing: prospective

Last update: 2020-08-03, 1399/05/13
Update count: 0
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
behnoosh najafi
Name of organization / entity
Razi university
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 3227
Email address
behnushnajafi106@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eight weeks Aqua Stretch and Dynamic Neuro Muscular Stabilization on Pain, Disability and foot pressure distribution in Patients with Nonspecific Chronic Low Back Pain
Public title
The Effect of Eight weeks Aqua Stretch and Dynamic Neuro Muscular Stabilization on Pain, Disability and foot pressure distribution in Patients with Nonspecific Chronic Low Back Pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
with chronic non-specific low back pain for three months or more 30 to 50 years of age the OSWESTRY score of 20 to 61 visual acuity pain (VAS) between 3 and 8
Exclusion criteria:
No surgery no back injury no pregnancy, pregnancy or less than 6 months after delivery no exercise at least 6 months before the test bone fractures history of back surgery
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Using random number generator software, the subjects will be assigned to three groups of physical exercises and control, and this process of number distribution will be performed by the software in a completely random manner. The evaluator is not aware of this random allocation and after evaluating each patient, they will be given a number from 1 to 52 and after evaluating, they will take their number envelope and it will be determined in which group they will be placed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects will be hidden using the SNOSE method of allocating subjects. In this way, the allocation sheet will be given to a non-involved person in the research and after evaluating each person, it will be announced in which group they will be placed. To blind the subjects, we will also give an educational intervention to the control group, which once a week will give ergonomic principles to the control group online in cyberspace to prevent mechanical pressures on the spine.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق در پژوهش دانشگاه رازی کرمانشاه
Street address
bag abrisham
City
kermanshah
Province
Kermanshah
Postal code
6714414874
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.RAZI.REC.1399.005

Health conditions studied

1

Description of health condition studied
Non-specific back pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Before the start of the intervention and one day after the end of the intervention
Method of measurement
pain with visual analog scale( VAS)

2

Description
disability
Timepoint
Before the start of the intervention and one day after the end of the intervention
Method of measurement
Disability with OSWESTRY

Secondary outcomes

1

Description
lumbopelvic control, balance, center of pressure,
Timepoint
Before the start of the intervention and one day after the end of the intervention
Method of measurement
Laboratory

Intervention groups

1

Description
Intervention group1: Eight weeks 3 sessions each week and 1 hour each session of dynamic neuromuscular stabilization exercises
Category
Rehabilitation

2

Description
Intervention group2: 8 weeks and 3 sessions per week and 1 hour of aqua stretching exercises for each session
Category
Rehabilitation

3

Description
Control group: The control group we will give an educational intervention that once a week in cyberspace, the control group will be given ergonomic training to prevent mechanical stress on the spine.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi University Sports Science Laboratory
Full name of responsible person
behnush najafi
Street address
baghabrisham
City
kermansha
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3428 3207
Email
behnushnajafi106@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
razi university
Full name of responsible person
farzad vysi
Street address
kermanshah
City
kermansha
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3428 3272
Email
behnushnajafi106@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
razi university
Proportion provided by this source
10
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
razi university
Full name of responsible person
behnush najafi
Position
studen
Latest degree
Master
Other areas of specialty/work
sport injury/corrective exercise
Street address
bag abrisham
City
kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3428 3207
Email
behnushnajafi106@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
razi university
Full name of responsible person
behnush najafi
Position
student
Latest degree
Master
Other areas of specialty/work
spor injury/corrective exercise
Street address
bagabrisham
City
kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3428 3207
Email
behnushnajafi106@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
razi university
Full name of responsible person
benush najafi
Position
student
Latest degree
Master
Other areas of specialty/work
sport injury/corretive exercise
Street address
baghabrisham
City
kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3428 3207
Email
behnushnajafi106@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is not much information
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
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