The effect of modified protocol of exercise therapy with psychological interventions specified for army staff with discogenic low back pain: A randomized clinical trial
The effect of modified protocol of exercise therapy with psychological interventions among army staff with discogenic low back pain
Design
Randomized control trial, based on society, parallel, single blind.
Settings and conduct
This study will be a single blind study as the assessor is not aware about the intervention protocols in groups and it will be conducted in Aja University of Medical Sciences, Tehran, Iran.
Participants/Inclusion and exclusion criteria
Class 11,1 ASA
age 18-60
Chronic low back pain for more than 3 months with at least two symptoms of discogenic low back pain
having difficulties in lifting heavy loads or feeling pain during changing the position
feel pain during bending
Absence of radicullar pain in lower limb during physical test
Absence of disc tearing
Presence of low intensity signals between vertebral area and absence of joint burst in MRI report
Intervention groups
1- Exercise therapy : (doing Williams and Macknzie exercises)
2- Exercise + psychological therapy: (doing Williams and Macknzie exercises followed by relaxation techniques)
3- control: : No intervention
Main outcome variables
pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171111037388N3
Registration date:2018-07-08, 1397/04/17
Registration timing:registered_while_recruiting
Last update:2018-07-08, 1397/04/17
Update count:0
Registration date
2018-07-08, 1397/04/17
Registrant information
Name
Ardalan Shariat
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 939 861 4772
Email address
a-shariat@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of modified protocol of exercise therapy with psychological interventions specified for army staff with discogenic low back pain: A randomized clinical trial
Public title
The effect of modified protocol of exercise therapy with psychological interventions specified for army staff with discogenic low back pain: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Class 11,1 ASA
Age 18-60
Chronic low back pain for more than 3 months with at least two symptoms of discogenic low back pain
Having difficulties in lifting heavy loads or feeling pain during changing the position
Feel pain during bending
Absence of radicullar pain in lower limb during physical test
Absence of disc tearing
Presence of low intensity signals between vertebral area and absence of joint burst in MRI report
Exclusion criteria:
Using of steroids or corticosteroid drugs
Absence of agreement for participation or continue the study
Absence of agreement for participation or continue the study
Having radicular pain in beginning or during of study
Having radicular pain in beginning or during of study
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be divided to three groups randomly based on the random block.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessors are not aware from the protocols of cycling done by participants in each groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Aja Medical University
Street address
Fatemi, Sindokht
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-06-09, 1397/03/19
Ethics committee reference number
IR.AJAUMS.REC.1397.004
Health conditions studied
1
Description of health condition studied
Discogenic low back pain
ICD-10 code
S30.8
ICD-10 code description
Other supe
Primary outcomes
1
Description
pain intensity
Timepoint
Baseline- after 6 weeks, after 12 weeks
Method of measurement
11 grade NRS
Secondary outcomes
1
Description
Quality of life
Timepoint
Baseline, after 6 weeks, and after 12 weeks from baseline
Method of measurement
Quality of Life Scale (QOLS)
2
Description
Anxiety and depression
Timepoint
Baseline, after 6 weeks, and after 12 weeks from baseline
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
3
Description
Back pain–related functional limitation
Timepoint
Baseline, after 6 weeks, and after 12 weeks from baseline
Method of measurement
FRI scale
Intervention groups
1
Description
Intervention group: Exercise therapy (doing Williams and Macknzie exercises)
Category
Rehabilitation
2
Description
Intervention group: Modified exercise therapy (doing Williams and Macknzie exercises followed by relaxation techniques)
Category
Rehabilitation
3
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Aja University of Medical sciences
Full name of responsible person
ِDr.Reza Alizade
Street address
West Fatemi, Shahid etemadzade
City
tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
rezalizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Reza Alizade
Street address
West Fatemi, Shahid etemad zade
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
rezalizadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Dr.Reza Alizade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
West Fatemi, Shahid etemadzade
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
rezalizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr.Reza Alizade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
West Fatemi, Shahid etemadzade
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
rezalizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr.Reza alizade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
West Fatemi, Shahid etemadzade
City
tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
rezalizadeh@gmail.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
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
We will publish the results as a scientific article without any name from participants
When the data will become available and for how long
After finish the protocol, the article will be published and will be available permanently
To whom data/document is available
After finish the protocol, the article will be published and will be available permanently
Under which criteria data/document could be used
As an article for academic purposes
From where data/document is obtainable
As an article for academic purposes
What processes are involved for a request to access data/document
Call to the corresponding author directly:
Ardalansh2002@gmail.com