Protocol summary

Study aim
The purpose of this study was to determine the effect of motor correction exercises using the mirror therapeutic approach on the severity of pain and disability in patients with chronic low back pain.
Design
A clinical trial with a control group, one blind, randomized, with a sample size of 72 people
Settings and conduct
After obtaining written consent, the patients referred to the medical centers of Ahvaz Jundishapur University were selected based on entry criteria and randomly assigned to two therapeutic group (36 patients) and control (36) randomly selected blocks. To be All patients were unaware of which part of their treatment was intended for this study, and there was no relationship between the two groups. All patients undergo a routine clinical rehabilitation program. During the same period of 10 weeks, the analgesic group after routine physiotherapy is undergoing therapy in a quiet and silent environment for 30 minutes. All exercises are performed by a researcher and a researcher (female) 3 sessions Weekly for 10 weeks.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include chronic non-specific chronic low back pain, age range 18 to 65, and the ability to exercise. Non-inclusion criteria include having weakness in exercise, smoking and alcohol consumption, and lack of satisfaction to enter the study.
Intervention groups
in front of the mirror for conterol group : 1. Spinal stabilizer exercise sitting on the ball 2. Spinal stabilizer exercise sitting without balls 3. Standing spinal stabilizer training The control group also deals only with routine physical therapy exercises.
Main outcome variables
reduce Severity of pain ؛ Severity of disability

General information

Reason for update
Acronym
آینه درمانی
IRCT registration information
IRCT registration number: IRCT20160726029086N4
Registration date: 2019-07-10, 1398/04/19
Registration timing: registered_while_recruiting

Last update: 2019-07-10, 1398/04/19
Update count: 0
Registration date
2019-07-10, 1398/04/19
Registrant information
Name
Nasrin Elahi
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8071
Email address
elahi-n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-08-09, 1398/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating of the Effect of Motor Correction Exercises on the Severity of Pain and Disability in Patients with Chronic Low Back Pain
Public title
The Effect of Motor Correction Exercises on the Severity of Pain and Disability in Patients with Back Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Non-specific chronic low back pain confirmed by the physician Age range 18 to 65 years Ability to do sports movements
Exclusion criteria:
weakness in exercise smoking alcohol consumption lack of satisfaction to enter the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Blindness in this study included participants. So, after randomization of the patients into the test and control group, none of them will know which of the two control or test groups belong.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Sepah Pasdaran Street, Razi Physical Therapy Clinic, Dehdasht
City
Ahvaz
Province
Khouzestan
Postal code
7513574463
Approval date
2019-01-12, 1397/10/22
Ethics committee reference number
9728-NCRCCD

2

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Ahvaz -shahre daneshgahi faculty of nursing and midwifery
City
Ahvz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-11-21, 1397/08/30
Ethics committee reference number
9728-NCRCCD

Health conditions studied

1

Description of health condition studied
Chronic back pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified

Primary outcomes

1

Description
Pain severity score in chronic pain questionnaire
Timepoint
before and after intervention
Method of measurement
Chronic pain questionnaire

2

Description
indicated of severity of disability
Timepoint
before and after intervention
Method of measurement
questionnaire of ossuria

Secondary outcomes

empty

Intervention groups

1

Description
Test group: In this study, the test group carries 3 sessions of routine physiotherapy for 10 weeks and each week. The test group follows the routine physiotherapy, in the front of the desired workout mirror, which includes the spinal stabilization training on the ball, the stabilization of the spine without a ball and the stabilization of the spine, by the researcher Physiotherapist has seen the necessary training).
Category
Rehabilitation

2

Description
Control group: Routine physiotherapy exercises for 10 weeks and 3 sessions per week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical centers affiliated to Jundishapur University of Ahvaz
Full name of responsible person
Nasrin Elahi
Street address
Medical centers affiliated to Jundishapur University of Ahvaz
City
َ Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8391
Email
nasrinelahi137@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badvi
Street address
Ground Floor, Vice Chancellor for Research and Technology of Ahvaz University of Medical Sciences, Shahr Daneshghahi
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Web page address
http://vchresearch.ajums.ac.ir/HomePage.aspx?site=vchresearch.ajums.ac&tabid=4937&lang=fa-IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
sharak daneshgah- nursing and midwifery faculty
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8391
Fax
Email
elahi-n@jums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nasrin Elahii
Position
PhD
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Ahvaz shaher daneshgahi , ursing and midwiferry faculty
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3550 5079
Email
Elahi-n@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Position
associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahvz , shahre daneshgahi, nursing and midwifery faculty
City
Ahvaz
Province
Khouzestan
Postal code
7513574463
Phone
+98 61 3373 8391
Email
elahi-n@ajums.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
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