Protocol summary
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Study aim
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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.
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Design
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A clinical trial with a control group, with parallel groups, double-blind, randomized, 26 patients in each group, randomization by permutation blocks.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Pain, disability, geometry of abdominal muscles and multifidus muscle, fear of movement, fear-avoidance beliefs, pain catastrophizing
General information
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Reason for update
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Considering that at the time of registration of the trial, we did not have an accurate prediction of the time of judging and acceptance of the trial, our expected time to start accepting patients was before the date of approval and registration of the code, therefore, we request to change the start time of accepting patients from 31 May 2023 to 17June 2023 we have Subsequently, the end time of sick leave will be changed to 17January 2024
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230505058095N1
Registration date:
2023-06-02, 1402/03/12
Registration timing:
prospective
Last update:
2023-06-06, 1402/03/16
Update count:
1
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Registration date
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2023-06-02, 1402/03/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-06-17, 1402/03/27
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Expected recruitment end date
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2024-01-17, 1402/10/27
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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.
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Public title
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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.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
52
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The randomization method used was permutation block method. (considering blocks of four with the number of 13 blocks)
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-05-03, 1402/02/13
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Ethics committee reference number
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IR.SUMS.REHAB.REC.1402.001
Health conditions studied
1
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Description of health condition studied
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Low back pain
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ICD-10 code
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M54.5
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ICD-10 code description
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Low back pain
Primary outcomes
1
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Description
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Pain
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Timepoint
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Before, immediately and one month after the study
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Method of measurement
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Visual analogue scale
2
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Description
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Disability
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Timepoint
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Before, immediately and one month after the study
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Method of measurement
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Persian version of Roland Morris questionnaire
3
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Description
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Geometry of abdominal muscles and multifidus muscle
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Timepoint
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Before and immediately after the study
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Method of measurement
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Ultrasound device
Secondary outcomes
1
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Description
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Fear of movement
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Timepoint
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Before, immediately and one month after the study
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Method of measurement
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Persian version of the Tampa questionnaire
2
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Description
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Pain catastrophizing
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Timepoint
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Before, immediately and one month after the study
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Method of measurement
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Persian version of pain catastrophizing questionnaire
3
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Description
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Fear-avoidance beliefs
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Timepoint
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Before, immediately and one month after the study
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Method of measurement
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Persian version of fear-avoidance beliefs questionnaire
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available