Protocol summary

Study aim
The Effect of Trunk Motor Control Exercises Along with Pain Neuroscience Education in Water and Land Environment on Disability, Psychological Variables and Postural Control of Patients with Non-Specific Chronic Low Back Pain.
Design
This Clinical Trial as Parallel Design. The Patients will be Completely Randomly Assigned to two Experimental Groups and one Control Group, so that Random Codes by an Evaluator who is not Aware of the Study Design Deliver them to the Patients. The Experimental Group will Receive Rehabilitation Protocol for 4 and 8 Weeks, and the Control Group will not Receive any Intervention.
Settings and conduct
All Tests and Rehabilitation Protocol will be done in the Laboratory and Swimming Pool of Bu-Ali Sina University. Patients will be Randomly Assigned to Two Experimental Groups and one Control Group, so that Random Codes will be Delivered to Patients by an Evaluator who is not Aware of the Study Design. As a Result, Patients and Assessors will be Unaware of Group Allocation.
Participants/Inclusion and exclusion criteria
Pain in Other Joints Misalignment of Upper and Lower Limbs History of Surgery Use of Painkillers in the Past 6 Months Physiotherapy in the Last Year Participate in Sports Sciatica Pain Spondylolysis Neuromuscular Disorders Neurological Disorder Respiratory Disorders Muscle Spasm Vertebral Fractures.
Intervention groups
Two Experimental Groups will Receive the Combination of Motor Control Exercises with Pain Neuroscience Education in Water and Land to 4 and 8 Weeks. The Third Group, Which is the Control Group, will not Perform any Rehabilitation Exercises During this Period.
Main outcome variables
Pain, Disability, Fear of Movement, Stress, Anxiety, Depression, Pain Catastrophizing, Posture Control, Plantar Pressure Distribution, Vertical Ground Reaction Force

General information

Reason for update
Acronym
CNSLBP
IRCT registration information
IRCT registration number: IRCT20240311061249N1
Registration date: 2024-03-30, 1403/01/11
Registration timing: retrospective

Last update: 2024-03-30, 1403/01/11
Update count: 0
Registration date
2024-03-30, 1403/01/11
Registrant information
Name
Fatemeh Sori
Name of organization / entity
Bu_Ali Sina University of Hamedan
Country
Iran (Islamic Republic of)
Phone
+98 81 3429 6149
Email address
fatemesori1862@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Trunk Motor Control Exercises Along with Pain Neuroscience Education in Water and Land Environment on Disability, Psychological Variables and Postural Control of Patients with Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
Public title
The Effect of Trunk Motor Control Exercises Along with Pain Neuroscience Education in Patients with Non-Specific Chronic Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from Chronic Low Back Pain for More than 3 Months The Cause of Low Back Pain is Unknown Age Range from 30 to 60 Years Pain Intensity more than 45 mm on the Visual Analog Scale Oswestrian Disability Index More than 25
Exclusion criteria:
Pain in other Joints Misalignment of Upper and Lower Limbs History of Surgery Use of Painkillers in the Past 6 Months Physiotherapy in the Last Year Participate in Sports Sciatica Pain Spondylolysis Neuromuscular Disorders Neurological Disorder Respiratory Disorders Muscle Spasm Vertebral Fractures
Age
From 30 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
First, Random Codes will be Generated Using Random Allocation Software and then they will be Placed Inside Sealed Envelopes. An Evaluator who is not Aware of the Study Purpose will Randomly Deliver the Envelopes to the Patients. As a Result, Patients will be Assigned to Experimental and Control Groups (30 People in Each Group) with a 1:1:1 Allocation. Patients and Assessors will be Unaware of Group Allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
First, Random Codes will be Generated Using Random Allocation Software and then they will be Placed Inside Sealed Envelopes. An Evaluator who is not Aware of the Study Purpose will Randomly Deliver the Envelopes to the Patients. As a Result, Patients will be Assigned to Experimental and Control Groups (30 People in Each Group) with a 1:1:1 Allocation. Patients and Assessors will be Unaware of Group Allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه بوعلی سینا
Street address
Madani Town, Azadegan Street, 2 Yas Alley, Azin Building, Unit 8
City
Hamedan
Province
Hamadan
Postal code
6513861328
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.BASU.REC.1402.095

Health conditions studied

1

Description of health condition studied
Chronic Non-Specific Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low Back Pain

Primary outcomes

1

Description
Pain, Fear of Movement, Stress, Anxiety, Depression, Pain Catastrophizing
Timepoint
In this Clinical Trial, the Researcher Intends to Evaluate the Variables of Pain, Fear of Movement, Stress, Anxiety, Depression, Pain Catastrophizing in Two time Periods Before the Intervention (Pre-Test) and After the Intervention (4 and 8 Weeks).
Method of measurement
Pain (Visual Analog Scale), Fear of Movement (Tampa Questionnaire), Stress, Anxiety and Depression (Stress, Anxiety and Depression Questionnaire), Pain Catastrophizing (Pain Catastrophizing Questionnaire)

Secondary outcomes

1

Description
Disability, Postural Control, Plantar Pressure Distribution, Vertical Ground Reaction Force
Timepoint
In this Clinical trial, the Researcher Intends to Evaluate Disability Variables, Posture Control, Plantar Pressure Distribution, Vertical Ground Reaction Force in two time Periods before the Intervention (Pre-Test) and after the Intervention (4 and 8 Weeks).
Method of measurement
Disability (Oswestory Questionnaire), Posture Control, Plantar Pressure Distribution and Vertical Ground Reaction Force (Foot Pressure)

Intervention groups

1

Description
Intervention Group: Motor Control Exercises in Four Weeks, 6 Sessions per Week (3 Sessions in the Swimming Pool of Bu-Ali Sina University and 3 Sessions in the Sports hall of Bu-Ali Sina University) Each Session will be done for 30 to 45 Minutes and the Neuroscience Education Includes 8 Topics Along with Verbal Explanations be Presented for 10 Minutes before the Beginning of the Treatment Sessions
Category
Rehabilitation

2

Description
Intervention Group: Motor Control Exercises will be done in Eight Weeks, (4 Weeks in Water and 4 Weeks on Land) Three Sessions per Week for 30 to 45 Minutes Each Session and Neuroscience Education Includes 8 Topics with Oral Explanations for 10 It will be Provided Minutes Before the Start of Treatment Sessions.
Category
Rehabilitation

3

Description
Control Group: They will not Receive any Intervention.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthopedic Clinics of Hamedan Province
Full name of responsible person
Fatemeh Sori
Street address
Madani Town, Azadegan Street, 2 Yas Alley, Azin Building, Unit 8
City
Hamedan
Province
Hamadan
Postal code
6513861328
Phone
+98 81 3429 6149
Email
fatemesori1862@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bu-Ali Sina University, Hamedan
Full name of responsible person
Ali Yalfani
Street address
Madani Town, Azadegan Street, 2 Yas Alley, Azin Building, Unit 8
City
Hamedan
Province
Hamadan
Postal code
6513861328
Phone
+98 81 3429 6149
Email
fatemesori1862@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
There is no source of financial support.
Proportion provided by this source
1
Public or private sector
Private
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
Bu-Ali Sina University, Hamedan
Full name of responsible person
Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Madani Town, Azadegan Street, 2 Yas Alley, Azin Building, Unit 8
City
Hamedan
Province
Hamadan
Postal code
6513861328
Phone
+98 81 3429 6149
Email
fatemesori1862@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bu-Ali Sina University, Hamedan
Full name of responsible person
Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Madani Town, Azadegan Street, 2 Yas Alley, Azin Building, Unit 8
City
Hamedan
Province
Hamadan
Postal code
6513861328
Phone
+98 81 3429 6149
Email
fatemesori1862@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bu-Ali Sina University, Hamedan
Full name of responsible person
Fatemeh Sori
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Madani Town, Azadegan Street, 2 Yas Alley, Azin Building, Unit 8
City
Hamedan
Province
Hamadan
Postal code
6513861328
Phone
+98 81 3429 6149
Email
fatemesori1862@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
All Data and Documents Can be Shared, but with the Non-Identification of People and the Preservation of Private Information of Subjects.
When the data will become available and for how long
The Results of this Study will be Available 3 Months after Publication in Journals.
To whom data/document is available
The Results of the Studies will be Accessible to all Members of the Society Without any Restrictions.
Under which criteria data/document could be used
The Presented Documentation Can be Used for the Treatment of Non-Specific Chronic Low Back Pain. These Interventions are Applicable if they are Prescribed and Supervised by a Physiotherapist.
From where data/document is obtainable
Fateme Soori's email Address is fatemesori1862@gmail.com
What processes are involved for a request to access data/document
When the Applicant Provides Documents for her Field of Work Related to the Subject of the Thesis and in Case of a Reasonable Request and a Commitment not to Misuse the Data of This Research, the Data will be Sent to her for 1 Working Week.
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