The comparison of lumbosacral manipulation with and without pain neuroscience education method in treatment of nonspecific chronic low back pain in athlete with sacroiliac dysfunction
The comparison of lumbosacral manipulation with and without pain neuroscience education method in treatment of nonspecific chronic low back pain in athlete with sacroiliac dysfunction
Design
Randomised clinical trial with control group, sample size of 38 subjects, permutation block randomization In blocks 4-digit blocks, 2 groups of intervention and control with 19 subjects in each group
Settings and conduct
Athletes who are referred to Shiraz School of Rehabilitation Sciences by a physician with a diagnosis of chronic non-specific low back pain will enter the study after evaluating the entry criteria. The intervention group will receive sacroiliac and lumbar manipulation technique with pain neuroscience education technique during 3 sessions and the control group will receive only sacroiliac and lumbar manipulation technique during 3 sessions
Participants/Inclusion and exclusion criteria
Age range 18-32, Non-specific chronic low back pain, Individuals who performed specialized exercise at least three times a week for two hours each session, Pain based on the Numerical Rate Scale (NRS) between 3 and 6, Functional disability based on the Oswestry Disability Index (ODI)questionnaire between 20 and 40, Catastrophizing pain based on the Pain Catasrophizing Scale (PCS) questionnaire between 26 and 39
Intervention groups
Intervention group: sacroiliac and lumbar manipulation technique with pain neuroscience education technique (3 sessions)
Control group: only sacroiliac and lumbar manipulation technique as a basic treatment (3 sessions)
The comparison of lumbosacral manipulation with and without pain neuroscience education method in treatment of nonspecific chronic low back pain in athlete with sacroiliac dysfunction
Public title
The effect of Pain Neuroscience Education technique on Nonspecific chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non-specific chronic low back pain
Who performed specialized exercise at least three times a week for two hours each session
Pain between 3 to 6 based on the NRS
Functional disability between 20 to 40 based on the ODI questionnaire
Catastrophizing pain between 26 and 39 based on the PCS questionnaire
sacroiliac dysfunction
Exclusion criteria:
Patient dissatisfaction
Do additional therapy in addition to the treatment specified in the study
Patients who are included in one of the cases of absolute non-use of interventions such as Recent infections, cancer, use anticoagulants, lymphedema, etc.
History of spine surgery
Osteoporosis
Leg length difference
Use of painkillers and anti-inflammatory drugs over the past three months
Recent physiotherapy in the past three months
Spinal deformities including scoliosis
Cauda equina syndrome
Neurological symptoms from pressure on the nerve
Disc herniation
Pregnancy
Inability to read and write
Having medical or paramedical information (such as neuroanatomy-neurophysiology information)
Age
From 18 years old to 32 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed by permutation block randomization method with 4-digit blocks (two groups of 19 subjects)
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher who will do the manipulation and assess the outcome measures, as well as the statistic specialist will be unaware of the control and intervention groups
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
Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-07-31, 1398/05/09
Ethics committee reference number
IR.SUMS.REHAB.REC.1398.023
Health conditions studied
1
Description of health condition studied
Chronic low back pain with sacroiliac dysfunction
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
pain intensity
Timepoint
Before, after 3 sessions and after one month
Method of measurement
Numerical rate scale
2
Description
Functional disabilities
Timepoint
Before, after 3 sessions and after one month
Method of measurement
Oswestry disability index
3
Description
Pain catasrophizing rate
Timepoint
Before, after 3 sessions and after one month
Method of measurement
pain catastrophizing scale questionnare
4
Description
Static balance with closed eyes
Timepoint
Before,after 3 sessions and after one month
Method of measurement
Single leg stance bilateraly with closed eyes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Performing sacroiliac and lumbar manipulation similar to the control group with a pain neuroscience education technique that teaches about pain management and control it.This technique is performed in three sessions and each session is about 90 minutes before other interventions by PowerPoint and clip And within a month, the taught material will be sent every week to remind them. In fact, PNE technique creates a new perception of the past and previous experience, Due to the lack of focus on the damaged tissue and Pain is taught simply in neurobiology and neurophysiology. In other words, the patient is informed about the mechanism of pain and neuroanatomy in practice And this makes it possible to identify false pains of psychological origin and improve them.
Category
Rehabilitation
2
Description
Control group: only perform lumbar and sacroiliac manipulation techniques as baseline treatment in three sessions
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz School of Rehabilitation Sciences
Full name of responsible person
Mohamad Mahdi Soltani
Street address
Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
rehab@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Zand Blvd.
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
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
Mohamad Mahdi Soltani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
NO. 3, West Mardani, Janbazan Blvd., Modares Blvd.
City
Shiraz
Province
Fars
Postal code
7155816345
Phone
+98 71 3720 7692
Email
m_soltani@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohamad Mahdi Soltani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 3 West Mardani St., Janbazan Blvd., Modares Blvd.
City
Shiraz
Province
Fars
Postal code
7155816345
Phone
+98 71 3720 7692
Email
m_soltani@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Soltani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 3, West Mardani, Janbazan Blvd., Modares Blvd.
City
Shiraz
Province
Fars
Postal code
7155816345
Phone
+98 71 3720 7692
Email
m_soltani@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The results will be published as an article in the research international journals
When the data will become available and for how long
In the next 1 to 2 years
To whom data/document is available
Only people who ask the main investigator for the information
Under which criteria data/document could be used
With the permission through a written or oral request
From where data/document is obtainable
School of Rehabilitation Sciences. Shiraz University of Medical Sciences
What processes are involved for a request to access data/document
School of Rehabilitation Sciences. Shiraz University of Medical Sciences