The effect of adding pain neuroscience education on the clinical results of core muscle training using pressure biofeedback in people with chronic low back pain diagnosed with functional instability
investigating the effect of adding pain neuroscience education on the clinical results of core muscle training using pressure biofeedback in people with chronic low back pain diagnosed with functional instability
Design
Randomized two arm parallel group trial with single blinded assessor,48 patient.
Settings and conduct
In Rofaydeh Hospital, Tehran, by using two explicit training methods, which include the addition of pain neuroscience education to core muscle training along with pressure biofeedback in people with chronic back pain, we aim to improve both the subjective aspects of back pain by using We will examine the changes in brain waves recorded by neurofeedback and analyze the biological dimensions of the morphological changes of the transverse abdominal muscle using musculoskeletal ultrasound, and finally we will examine pain, disability and fear of movement.All criteria are performed by an blind evaluator . After the initial evaluation, the participants are randomly divided into two groups during the block.the measurement is done in the first treatment sessions and immediately after 15th session and in order to follow up the participants, three months after the end of the treatment, again the primary evaluation criteria are measured by the evaluator. during the three-month follow-up , the participant will not receive anytreatment .
Participants/Inclusion and exclusion criteria
People with chronic back pain diagnosed with functional instability who do not suffer from nerve and muscle pain with a specific cause
Intervention groups
core muscle training with pressure biofeedback device,core muscle training with pressure biofeedback device plus pain neuroscience education
Main outcome variables
brain wave with neurofeedback,transverse abdominal muscle with sonography, pain in the visual analogous scale,disability in Oswestry disability index,and fear of movement with a Tampa scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240916063057N1
Registration date:2024-10-20, 1403/07/29
Registration timing:prospective
Last update:2024-10-20, 1403/07/29
Update count:0
Registration date
2024-10-20, 1403/07/29
Registrant information
Name
Golnaz Sadria
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 5198
Email address
gl.sdr9019@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-17, 1403/08/27
Expected recruitment end date
2025-08-18, 1404/05/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding pain neuroscience education on the clinical results of core muscle training using pressure biofeedback in people with chronic low back pain diagnosed with functional instability
Public title
the effect of education in treatment of chronic low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age range 18-40
at least education level is diploma
prone instability test is positive
Gower’s sign is positive
at least 3 month patient have continuous pain in lumbago
there is no obvious symptom in lumbar region ( patients rule out when have these disorder: decrease sensation in specific dermatome , decrease strength in specific myotome of lumbar region , disc herniation ,sacroiliac joint dysfunction )
at least patient have 3times low back pain during last year
intensity of patient's pain during Gower’s test in Visual Analogous Scale should be 3to7
Oswestry disability index more than 12%
patient can stand and walk without any supportive aid such as cane
patient don't have Rheumatoid and central nervous system disorder
patient don't have any history of tumor, malignancy and spinal malposture
patient don't have any history of abdominal surgery
at least score of MMSE for measuring cognition state should be 27
BMI not more than 30
patient don't get any medications and exercise therapy during last 3 month
Exclusion criteria:
pregnancy
sitting more than 2 hours a day
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
People referring to the Physiotherapy Department of ROFAYDEH Hospital, Department of Low Back Pain School are first examined by the senior researcher (NOT BLIND) according to the Inclusion criteria. If they meet the Inclusion criteria, they are included in the study.) Using the www.sealed envelope.com website with a block size of 4 (block size n=4) a random sequence is made Then, one of the 6 modes AABB, ABAB, ABBA, BBAA, BABA, BAAB will be randomly selected, where A represents the first group and B represents the second group. Then the blind assessor seals using non-transparent envelopes the random sequences generated by the site are placed in envelopes for every 48 people, and people take one of the 48 envelopes without putting them in the order of arrival and enter the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Therapist doesn't blind to type of treatment and assessment and both groups
Assessor blind to type of treatment and assessment and both groups
Patient don't blind to type of treatment and groups
Statistics analyzer blind to treatment and assessment and both groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of social welfare and rehabilitation science
Street address
Koodakyar End, Shahid Shahriari Square,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2024-09-28, 1403/07/07
Ethics committee reference number
IR.USWR.REC.1403.134
Health conditions studied
1
Description of health condition studied
chronic low back pain diagnosed with functional instability
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
pre treatment,immediate after fifteen session,Three months after the end of treatment
Method of measurement
visual analogous scale
Secondary outcomes
1
Description
disability
Timepoint
pre treatment, immediate after fifteen sessions , Three months after the end of treatment
Method of measurement
Oswestry disability index
2
Description
fear of movement
Timepoint
pre treatment, immediate after fifteen sessions , Three months after the end of treatment
Method of measurement
tampa scale
3
Description
thickness of transverse abdominis muscle
Timepoint
pre treatment, immediate after fifteen sessions , Three months after the end of treatment
Method of measurement
sonography
4
Description
brain wave
Timepoint
pre treatment, immediate after fifteen sessions , Three months after the end of treatment
Method of measurement
neurofeedback
Intervention groups
1
Description
Intervention group: core muscle training using pressure biofeedback device along with pain neuroscience education
Category
Rehabilitation
2
Description
Control group: core muscle training using pressure biofeedback device
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofaydeh hospital
Full name of responsible person
Golnaz Sadria
Street address
nemati Alley,south salimi Ave,gheytarieh
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 23570
Email
rofeideh.hospital@uswr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
mohammad saeed khanjani
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2822
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Golnaz Sadria
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
gl.sdr9019@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Golnaz Sadria
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
gl.sdr9019@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Golnaz Sadria
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
gl.sdr9019@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All ethical forms and documents and informed consent in the process of receiving the code of ethics are registered in the proposal
When the data will become available and for how long
8 months after the publication of the results of the thesis and the publication of the article extracted from the thesis
To whom data/document is available
Senior Researcher (Golnaz Sadria)
Ethics Committee of the University of social welfare and Rehabilitation Sciences
Under which criteria data/document could be used
It can be retrieved only if the patient's physical condition becomes problematic and for a detailed examination of the information and the treatment process
From where data/document is obtainable
In order to receive the results of the research, the contact numbers of the patients and their communication channels are included in the informed consent form, and after the review and analysis of the data by the senior researcher, the results will be provided to the participants via email or face-to-face meeting.
What processes are involved for a request to access data/document
First, according to the informed consent form, in which the number of the senior researcher (Golnaz Sadria) is mentioned, contact is made with that number, then after explaining the reason for receiving the documents to the senior researcher and presenting it to the ethics committee of the University of social welfare and rehabilitation science, information After unlocking, the code will be provided to the participant.