Evaluation of the effect of high-intensity laser therapy compared to low-intensity laser therapy in improving the symptoms of lumbosacral disc herniation patients with radiculopathy
Investigating the effect of high-intensity laser therapy in improving the symptoms of lumbosacral discopathy patients with radiculopathy and comparing its effect with low-intensity laser therapy
Design
A two-group, single-blind, phase 3 clinical trial on 50 patients
Settings and conduct
This study will be conducted on patients who come to the physical medicine and rehabilitation clinic of Shohad Tajrish Hospital in Tehran with complaints of low back pain.
Participants/Inclusion and exclusion criteria
Eligibility criteria:
Patients who have lumbosacral discopathy based on history, examination and MRI findings.
Exclusion criteria:
a) Non-cooperation and failure to complete the 10-session treatment course b) Questionnaires that are incompletely completed or more than one question is answered. c) History of spinal fracture or surgery d) History of epidural steroid injection in the previous 4 weeks e) Presence of malignancy g) Pregnancy h) Having a cardiac pacemaker
Intervention groups
Dividing into two groups, one group is treated with high-intensity laser therapy and the other group is treated with low-intensity laser therapy.
Main outcome variables
a) Examining the effect of treatments performed on reducing patients' pain, b) Examining the effect of treatments performed on reducing patients' disability, c) Examining the effect of treatments performed on improving quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240115060701N1
Registration date:2024-01-23, 1402/11/03
Registration timing:prospective
Last update:2024-01-23, 1402/11/03
Update count:0
Registration date
2024-01-23, 1402/11/03
Registrant information
Name
Abdoljabbar Mozaffari Komsh Tappeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
jabbarmozaffari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of high-intensity laser therapy compared to low-intensity laser therapy in improving the symptoms of lumbosacral disc herniation patients with radiculopathy
Public title
Evaluation of the effect of high-intensity laser therapy compared to low-intensity laser therapy in improving the symptoms of lumbosacral disc herniation patients with radiculopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who attend the physical medicine and rehabilitation clinic with low back pain
Exclusion criteria:
History of spinal fracture or surgery
History of epidural steroid injection within 4 weeks before
Presence of Malignancy
Pregnancy
Having a cardiac pacemaker
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, according to the design, the patient is subjected to standard treatment, only the patient is not informed whether the treatment is high-power or low-power laser to reduce bias.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of Shahid Beheshti University of Medical Sciences and Healthcare Services
Street address
Shahid Beheshti University of Medical Sciences, Shahid Arabi Street, Yaman Street, Shahid chamran Highway,
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-07-01, 1402/04/10
Ethics committee reference number
IR.SBMU.MSP.REC.1402.175
Health conditions studied
1
Description of health condition studied
Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Low Back Pain
Timepoint
At the beginnigng of the study ( before the start of the treatment) and 1 months after treatment
Method of measurement
Visual Analogue Scale ( VAS )
2
Description
Degree of disability
Timepoint
At the beginnigng of the study ( before the start of the treatment) and 1 months after treatment
Method of measurement
Oswestry Disability Index (ODI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25 patients with low back pain who will be treated with 10 session of High Intesity Laser Therapy, 5 session per week with a frequency of 25 Hz, power of 10 watts, with a dose of 12 j/cm2 in the lumbar region for 4 minutes in biostimulation mode, followed by continuous mode for 6 minutes with a power of 7 watts and a dose of 10 j/cm2
Category
Treatment - Devices
2
Description
Intervention group: 25 patients with low back pain who will be treated with 10 session of Low Intesity Laser Therapy, 5 session per week, GaAlAs infrared radiation, wavelength 808 nm, power 160 mV and penetration depth 4 cm
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All the data of people participating in this study can be shared after deidentifying people
When the data will become available and for how long
The access period starts one year after the results are published.
To whom data/document is available
Data of this study will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of patients will be provided to the researchers.
From where data/document is obtainable
By Sending an email to jabbarmozaffari@sbmu.ac.ir
What processes are involved for a request to access data/document
Sending an email requesting information and explaining the purpose and how to use the data