Comparison of back pain, EMG/NCS, light touch and pin prick in patients with chronic back pain in two groups before intervention
Design
In this random study, double-blind and using a control group of 30 patients with mechanical back pain referred to the clinic of Imam Khomeini Hospital who were diagnosed by a physical medicine specialist based on diagnostic criteria and randomly Two intervention and control groups are divided.
Settings and conduct
In this study, two types of exercise therapy protocols will be selected. The first exercise therapy protocol is in accordance with common exercise movements whose effectiveness has been agreed upon and will be recommended to patients in therapy lists. The second protocol also included sports movements that did not have any effect in the treatment of back pain and basically the place of effect is outside the back area. This protocol will be performed as a placebo in the laser group only.
Participants/Inclusion and exclusion criteria
Log into: Chronic low back pain
Log out: spondylolisthesis and another neurologic disease
Intervention groups
The control group of 30 patients with mechanical back pain referred to Imam Khomeini Hospital Clinic
In this study, two types of exercise therapy protocols will be selected. The first exercise therapy protocol is in accordance with common exercise movements whose effectiveness has been agreed upon and will be recommended to patients in therapy lists. The second protocol also included sports movements that did not have any effect in the treatment of back pain and basically the place of effect is outside the back area. This protocol will be performed as a placebo in the laser group only.
Main outcome variables
The pain
Disability
Waist movements
EMG/NCS
Light touch
Pin prick
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230827059275N1
Registration date:2023-10-23, 1402/08/01
Registration timing:registered_while_recruiting
Last update:2023-10-23, 1402/08/01
Update count:0
Registration date
2023-10-23, 1402/08/01
Registrant information
Name
sara arefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 3821
Email address
arefi.s@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using MLS laser in reducing pain in patients with chronic low back pain
Public title
effect of using laser in reducing pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with radicular back pain with age less than 65 years and duration of back pain more than 3 months with or without pain
Exclusion criteria:
Simultaneous involvement of nerve roots and neurological and sensory disorders
Disorders caused by pressure on the spinal cord such as spondylolisthesis
Severe instability of the vertebrae
History of back surgery
severe osteoporosis
Infection at the site of the spinal cord
Patient dissatisfaction
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be a simple randomization type, where 30 beads of the same shape and size will be selected with black and white color, and then these 30 beads will be mixed and thrown into a non-transparent bag, when the patient visits According to the conditions of entry into the study, a bead is removed from the bag by the researcher, and if the bead is black, the patient will enter the control group, and if the bead is white, the patient will enter the intervention group, and this bead will be kept inside another bag. This will be repeated 30 times.
Blinding (investigator's opinion)
Double blinded
Blinding description
For the purpose of blinding, people from the research team who are responsible for the selection and randomization of patients will not enter the other stages of the research, especially the examination of people in terms of the dependent variable. Also, after the consent form was filled and the procedure was explained, the patients and their companions were divided without knowing which of the intervention or control groups they were in. On the other hand, the same placebo will be used in control group patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Golestan Hospital Research
Street address
Golestan Ave, Golestan Hospital, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Approval date
2022-11-01, 1401/08/10
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.115
Health conditions studied
1
Description of health condition studied
Investigating the effect of using MLS laser in reducing pain in patients with chronic back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
pain
Timepoint
start and end of study
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, two types of exercise therapy protocols will be selected, the first exercise therapy protocol according to the common exercise movements whose effectiveness is agreed upon and will be recommended to patients in the treatment systems.
Category
Treatment - Other
2
Description
Intervention group: Then, the second protocol also includes sports movements that have no effect in the treatment of back pain, and basically the place of effect is outside the back area, which will be performed as a placebo in the laser group only.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
Seyed Reza Saedian
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3311 3821
Email
arefi.s@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
University of medical science, Golestan street, Golestan town، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3311 3821
Email
arefi.s@yahoo.com
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
Seyed Reza Saedian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
24 metery street, east sahely highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3311 3821
Email
saeidian@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed Reza Saedian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
24 metery street, east sahely highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3311 3821
Email
saeidian@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed Reza Saedian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
24 metery street, east sahely highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3311 3821
Email
saeidian@ajums.ac.ir
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
All data can be shared after de-identifying individuals
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Employees in academic institutions
Under which criteria data/document could be used
Other data is unpublishable
From where data/document is obtainable
sara arefi .
arefi.s@yahoo.com
What processes are involved for a request to access data/document