Clinical trial of postural restoration institute (PRI) training on pain, disability and selected biomechanical variables during walking in middle-aged men with and without nonspecific chronic low back pain with emphasis on modeling
Clinical trial of eight weeks of (PRI) training on pain, disability, kinematics (coordination and variability) and kinetics (joint power) during walking in middle-aged men with and without chronic nonspecific low back pain with emphasis on modeling.
Design
A clinical trial of Postural restoration Institute exercises with two control groups (healthy 14 and low back pain 14), with Parallel groups, not blinded, quasi-experimental grouping on 14 low back pain patients
Settings and conduct
The intervention group performed (PRI) exercise at the Behbood Center of Corrective Movement and Health for eight weeks, three sessions per week and each session for about 1 hour. This research is semi-experimental. There were 42 participants and they were divided into three groups: healthy (n = 14), control (n = 14) and intervention (14). Data were collected based on Visual Analogue Scale (VAS) and Roland Morris Disability Questionnaire (RMDQ) as well as biomechanical variabilitys before and after the intervention. The intervention group participated in a three-hour training session on the research process and how to perform the Training of the Posture Restoration Institute (PRI).
Participants/Inclusion and exclusion criteria
Having nonspecific chronic low back pain; Having pain in the lower back and buttocks; No severe injuries to the upper and lower limbs; Being in the age range of 30 to 50 years; Absent of any major orthopedic or neuromuscular surgery; No disc herniation and spinal canal stenosis
Intervention groups
Intervention group: A group of people with chronic non-specific low back pain to whom the exercises of the Posture restoration Institute are applied.
Control group: Tow groups of healthy people and low back pain patient to compare the biomechanical variables of the intervention group with them.
Main outcome variables
Pain; disability; joints range of motion.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211127053189N1
Registration date:2021-12-15, 1400/09/24
Registration timing:retrospective
Last update:2021-12-15, 1400/09/24
Update count:0
Registration date
2021-12-15, 1400/09/24
Registrant information
Name
Ali Salimi
Name of organization / entity
The University of Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 31 4547 4841
Email address
std_alisalimi@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
2021-05-10, 1400/02/20
Actual recruitment end date
2021-06-05, 1400/03/15
Trial completion date
2021-08-24, 1400/06/02
Scientific title
Clinical trial of postural restoration institute (PRI) training on pain, disability and selected biomechanical variables during walking in middle-aged men with and without nonspecific chronic low back pain with emphasis on modeling
Public title
Clinical trial of postural restoration institute (PRI) training on pain, disability and selected biomechanical variables
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No medical prohibition to participate in the training program
ability and opportunity to study
no moral prohibition to participate
no upper and lower limb injuries
no visible deformity
being in the age range of 30 to 50 years
filling satisfaction Conscious
no injury from injury or load on the lumbar region, disc herniation or spinal canal stenosis
Exclusion criteria:
Reluctance to participate for any reason
A history of dangerous symptoms related to specific low back pain
Observe signs of neurological problems that include weakness or numbness in the lower extremities
Any lower limb changes that potentially alter trunk movement while standing (For example leg fractures)
Vestibular disorder (balance problem) is observed in the person
The person has severe mental health problems
Roland Morris Low Back Disability Questionnaire scores less than 5
Age
From 30 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Actual sample size reached:
42
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kharazmi University Ethics Committee
Street address
Faculty of physical education; South Razan; Mirdamad;Tehran
City
Tehran
Province
Tehran
Postal code
Iran
Approval date
2019-12-09, 1398/09/18
Ethics committee reference number
IR.KHU.REC.1399.024
Health conditions studied
1
Description of health condition studied
Nonspecific chronic low back pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain (based on visual analog scale, Score between 3 and 6 )
Timepoint
Before and after exercise
Method of measurement
Visual analog scale, Score between 3 and 6
2
Description
disability
Timepoint
Before and after exercise
Method of measurement
Roland Morris Disability Questionnaire, Score more than 5
3
Description
Range of motion
Timepoint
Before and after exercise
Method of measurement
Inclinometer
Secondary outcomes
1
Description
kinematic variables of gait
Timepoint
Before and after exercise
Method of measurement
Qualisys motion capture system
2
Description
kinetic variables of gait
Timepoint
Before and after exercise
Method of measurement
kistler force platform
Intervention groups
1
Description
Intervention group: The intervention group performed (PRI) exercise at the Behbood Center of Corrective Movement and Health for eight weeks, three sessions per week and each session for about 1 hour.
Category
Rehabilitation
2
Description
Control group: Healthy group to compare with the intervention group who did not do any exercise program.
Category
Other
3
Description
Control group: Low back pain control group without exercise to neutralize the effect of time on the desired variables.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of Behbood health and corrective movements
Full name of responsible person
Fatemeh Fazel Najafabadi
Street address
Behbood Health and Correctional Movements Center, Abuzar Alley, Abolghasem Street
City
Najaf Abad
Province
Isfehan
Postal code
Iran
Phone
+98 31 4261 1077
Email
std_alisalimi@khu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of kharazmi
Full name of responsible person
Ali Salimi
Street address
Faculty of physical education; Kharazmi University; Tehran
City
Tehran
Province
Tehran
Postal code
iran
Phone
+98 21 8832 9220
Email
std_alisalimi@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
researchist
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Ali salimi
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
sports biomechanics
Street address
Faculty of physical education;Kharazmi University;Tehran
City
Tehran
Province
Tehran
Postal code
Iran
Phone
0982188329220
Email
std_alisalimi@khu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Haidar Sadeghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports biomechanics
Street address
Faculty of physical education;Kharazmi University;Tehran
City
Tehran
Province
Tehran
Postal code
Iran
Phone
+98 912 245 3175
Email
sadeghih@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Ali Salimi
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Sport biomechanics
Street address
Faculty of physical education;Kharazmi University;Tehran
City
Tehran
Province
Tehran
Postal code
Iran
Phone
+98 937 017 8250
Email
std_alisalimi@khu.ac.ir
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