Investigating the effect of adding pain neuroscience education to stabilization exercises using a flexi-bar on pain, disability, abdominal and multifidus muscles geometry in patients with chronic non-specific low back pain.
Investigating the effect of adding pain neuroscience education to stabilization exercises using a flexi-bar on pain, disability, abdominal and multifidus muscle geometry in patients with chronic non-specific low back pain.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, 26 patients in each group, randomization by permutation blocks.
Settings and conduct
Both groups of patients will receive their treatment at the Shiraz Rehabilitation Faculty clinic. In the control group, patients will be given stabilization exercises with flexi-bars, and In addition to this, PNE training will also be provided to the patients in the experimental group .Patients and co-evaluators will be blinded in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age group between 20 and 50 years of both sexes if more than 3 months have passed since the onset of symptoms, Average pain intensity between 3-7, minimum education level of diploma, Disability level greater than 8 . exclusion criteria: A history of malignancy in the area of the lumbar spine and its metastasis to any area, Systemic or local infections, History of inflammatory and systemic diseases, Presence of structural disorders of the spine, History of neurological diseases and brain damage, History of lower limb, abdominal and lumbar surgeries, Pregnancy, History of physiotherapy treatments and participation in regular sports exercises in the last three months, Musculoskeletal and orthopedic disorders of the limbs
Intervention groups
In the control group, patients will receive stabilization exercises with flexi bar, and in the experimental group, in addition to this, patients will also receive pain neuroscience education training.
Main outcome variables
Pain, disability, geometry of abdominal muscles and multifidus muscle, fear of movement, fear-avoidance beliefs, pain catastrophizing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230505058095N1
Registration date:2023-06-02, 1402/03/12
Registration timing:registered_while_recruiting
Last update:2023-06-02, 1402/03/12
Update count:1
Registration date
2023-06-02, 1402/03/12
Registrant information
Name
Zahra Dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 223 0842
Email address
zahradehghani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-31, 1402/03/10
Expected recruitment end date
2023-12-01, 1402/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of adding pain neuroscience education to stabilization exercises using a flexi-bar on pain, disability, abdominal and multifidus muscles geometry in patients with chronic non-specific low back pain.
Public title
Investigating the effect of adding pain neuroscience education to stabilization exercises using a flexi-bar on pain, disability, abdominal and multifidus muscles geometry in patients with chronic non-specific low back pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group between 20 and 50 years of both sexes if more than 3 months have passed since the onset of symptoms.
Average pain intensity based on a visual analogue scale between 3-7
Having a minimum education level of a diploma
If the functional disability level of the patients is more than 8 based on the Roland Morris Disability Questionnaire, they are included in the study.
Exclusion criteria:
A history of malignancy in the area of the lumbar spine and its metastasis to any area
Systemic or local infections that cause acute and severe pain in the lower back
History of inflammatory and systemic diseases such as diabetes and rheumatoid arthritis
Presence of structural disorders of the spine
History of neurological diseases and brain damage
History of the lower limb, abdominal and lumbar surgeries
Pregnancy
History of physiotherapy treatments and participation in regular sports exercises in the last three months
Musculoskeletal and orthopedic disorders of the upper and lower limbs
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method used was permutation block method. (considering blocks of four with the number of 13 blocks)
Blinding (investigator's opinion)
Double blinded
Blinding description
A physiotherapist applies the interventions and another physiotherapist colleague, who is unaware of the patient grouping, performs the evaluations. Also, the participants of the two groups will be treated in a separate place where they will not have any contact with each other.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz, Zand St., Shiraz University of Medical Sciences, Central Building, 7th Floor, Research and Technology Vice-Chancellor, Secretariat of the Research Ethics Committee of the University
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-05-03, 1402/02/13
Ethics committee reference number
IR.SUMS.REHAB.REC.1402.001
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
Before, immediately and one month after the study
Method of measurement
Visual analogue scale
2
Description
Disability
Timepoint
Before, immediately and one month after the study
Method of measurement
Persian version of Roland Morris questionnaire
3
Description
Geometry of abdominal muscles and multifidus muscle
Timepoint
Before and immediately after the study
Method of measurement
Ultrasound device
Secondary outcomes
1
Description
Fear of movement
Timepoint
Before, immediately and one month after the study
Method of measurement
Persian version of the Tampa questionnaire
2
Description
Pain catastrophizing
Timepoint
Before, immediately and one month after the study
Method of measurement
Persian version of pain catastrophizing questionnaire
3
Description
Fear-avoidance beliefs
Timepoint
Before, immediately and one month after the study
Method of measurement
Persian version of fear-avoidance beliefs questionnaire
Intervention groups
1
Description
Intervention group: Patients in the experimental group will perform stabilization exercises with flexi-bar in prone , standing, and quadruped positions simultaneously with the ADIM maneuver 3 times a week for 6 weeks. Also, once a week for six weeks, PNE training related to the physiology and neurophysiology of pain will be provided to the patients.
Category
Rehabilitation
2
Description
Control group: Patients in the control group will perform stabilization exercises with flexi-bar in prone , standing, and quadruped positions simultaneously with the ADIM maneuver 3 times a week for 6 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Rehabilitation Faculty Specialized Clinic
Full name of responsible person
Sara Abolahari Shirazi
Street address
Chamran Blvd. - 1 Abivardi St. - Faculty of Rehabilitation Sciences
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3626 5108
Email
SAhrari@Sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Yunus Ghasemi
Street address
Zand St., in front of Palestin St., Shiraz University of Medical Sciences Central Building, Research Assistant
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sara Abolahari Shirazi
Position
Assistant Professor of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shiraz Faculty of Rehabilitation Sciences, 1 Abivardi St., Chamran Blvd
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3627 1551
Email
SAhrari@Sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sara Abolahari Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shiraz Faculty of Rehabilitation Sciences, 1 Abivardi St., Chamran Blvd
City
Shiraz
Province
Fars
Postal code
۷۱۹۴۷-۳۳۶۶۹
Phone
+98 71 3627 1552
Email
SAhrari@Sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Dehghani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shiraz Faculty of Rehabilitation Sciences, 1 Abivardi St, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
۷۱۹۴۷-۳۳۶۶۹
Phone
+98 71 3627 1551
Email
zahradgh97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available