Comparison of the effectiveness of home exercise with and without pain neuroscience training and breathing exercises on pain, disability and muscle function in people with chronic nonspecific back pain
The effect of a combination of pain neuroscience training and breathing exercises on pain, disability and muscle function in people with low back pain
Design
Clinical trial with control group, experimental, single blind, randomized on 40 patients.
A sphere will be used for randomization
Settings and conduct
The study site is Faraz Clinic in Isfahan. This study is performed as a single blind in such a way that the subjects are not aware that they are in the control or experimental group and after taking out the number from the sphere receive their intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20 and 60 years with normal body mass index; chronic low back pain (more than 3 months) and nonspecific (doctor's approval). Non-Inclusion criteria: spinal cord injury and diseases such as inflammatory tumor fracture, etc.; smoking
Intervention groups
The experimental group will perform breathing exercises (90/90 BRIDGE WITH BALL AND BALLOON) along with home exercises. The experimental group will participate in 3 sessions of pain neuroscience classes held by a therapist with knowledge in this field. Each session lasts between 30 and 60 minutes. The control group does only home exercises
Main outcome variables
Pain; Muscle function; Disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210618051611N1
Registration date:2021-08-11, 1400/05/20
Registration timing:registered_while_recruiting
Last update:2021-08-11, 1400/05/20
Update count:0
Registration date
2021-08-11, 1400/05/20
Registrant information
Name
Amir Mohamad Tarakameh Samani
Name of organization / entity
The university of kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 31 3580 6106
Email address
amirtarakameh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-09-01, 1400/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of home exercise with and without pain neuroscience training and breathing exercises on pain, disability and muscle function in people with chronic nonspecific back pain
Public title
Effect of combination of pain neuroscience education and breathing exercise on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 60 years
Normal body mass index
Chronic back pain (more than 3 months) and nonspecific (doctor approved)
Not using medication or other interventions during the research
The person has the ability to perform rehabilitation steps without assistance and has obtained a score of at least 14 in the assessment of disability
Exclusion criteria:
Dissatisfaction to participate in research
Having any lower limb injuries, fractures and visceral diseases
Smoking
Not having the minimum disability score
Having spinal cord injuries and diseases such as (inflammatory fracture, etc.)
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly allocated into two groups of home exercises with and without pain neuroscience training and breathing exercises by taking out the number from a pre-designed ball. People who take the even number out of the sphere will be placed in the intervention group and people who take the odd number will be placed in the control group
Blinding (investigator's opinion)
Single blinded
Blinding description
An independent person who is not involved in any of the study processes will be responsible for how randomization is performed. Subjects are not aware of which training group they are allocated to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Physical Education Research Institute
Street address
building no 17; 21 Alley; Meraj Avenue
City
Esfahan
Province
Isfehan
Postal code
8199134569
Approval date
2021-05-17, 1400/02/27
Ethics committee reference number
IR.SSRI.REC.1400.1052
Health conditions studied
1
Description of health condition studied
low back pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
The first day and 34 days after the interventions
Method of measurement
Pain questionnaire
2
Description
disability
Timepoint
The first day and 34 days after the interventions
Method of measurement
questionnaire
3
Description
Muscle function
Timepoint
The first day and 34 days after the interventions
Method of measurement
Testing
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the experimental group, each person participates in 3 sessions of pain neuroscience training classes held by a knowledgeable therapist in this field, each session lasting between 30 to 60 minutes. The experimental group will also perform breathing exercises (90/90 BRIDGE WITH BALL AND BALLOON) along with home exercises
Category
Other
2
Description
Control group: The control group will do home exercises without receiving breathing exercises and pain neuroscience training.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Physiotherapy
Full name of responsible person
Amir Samani
Street address
No. 7;West Arghavan Ave; Farahzadi Blvd; Qods
City
Esfahan
Province
Isfehan
Postal code
9913245689
Phone
+98 31 3580 6106
Email
amirtarakameh@jmail.com
Web page address
http://dr-golshani.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Amir letafatkar
Street address
No. 7; West Arghavan Ave; Farahzadi Blvd; Qods Town
City
Esfahan
Province
Isfehan
Postal code
0987675413
Phone
+98 21 8765 3212
Email
amirtarakameh@jmail.com
Web page address
http://dr-golshani.ir/
Grant name
Grant code / Reference number
1233
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Kharazmi
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
The University of Kharazmi
Full name of responsible person
Amir samani
Position
Consultan
Latest degree
Master
Other areas of specialty/work
sport injury
Street address
No. 7; West Arghavan Ave; Farahzadi Blvd; Qods Town
City
Esfahan
Province
Isfehan
Postal code
9988776655
Phone
+98 21 6655 4321
Email
amirtarakameh@jmail.com
Web page address
http://dr-golshani.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Amir Samani
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No. 7 ;West Arghavan Ave; Farahzadi Blvd; Qods Town
City
Esfahan
Province
Isfehan
Postal code
1123654539
Phone
+98 31 3580 6106
Email
amirtarakameh@gmail.com
Web page address
https://www.varzesh3.com/
Person responsible for updating data
Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Morteza Samani
Position
Consultant
Latest degree
Bachelor
Other areas of specialty/work
sport injury
Street address
No. 7 ;West Arghavan Ave; Farahzadi Blvd; Qods Town
City
Esfahan
Province
Isfehan
Postal code
4357890091
Phone
+98 31 3580 6106
Email
amirtarakameh@gmail.com
Web page address
https://www.varzesh3.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
After studying the data, such as age, sex, weight, pain, disability and muscle function will be shared anonymously
When the data will become available and for how long
The access period will start 6 months after the results are published
To whom data/document is available
Scholars and people who work the industry
Under which criteria data/document could be used
based on researchers agreement
From where data/document is obtainable
amirtarakameh@gmail.com
What processes are involved for a request to access data/document
After sending the email and confirmation by the author, the file will be sent