1. Determining and comparing VAS score in two groups of patients with low back pain treated with physiotherapy and laser therapy
2. Determination and comparison of disability (based on Oswestry Disability Index (ODI) criteria) in two groups of patients with low back pain treated with physiotherapy and laser therapy
3. Determining and comparing the rate of direct lumbar flexion in two groups of patients with low back pain treated with physiotherapy and laser therapy
4. Determining and comparing the rate of lumbar flexion from the right side in two groups of patients with low back pain treated with physiotherapy and laser therapy
5. Determining and comparing the rate of left-back flexion in two groups of patients with low back pain treated with physiotherapy and laser therapy
6. Determining and comparing the amount of rotation to the right of the waist in two groups of patients with low back pain treated with physiotherapy and laser therapy
7. Determining and comparing the amount of left rotation in two groups of patients with low back pain treated with physiotherapy and laser therapy
Design
Clinical trial with control group, with parallel group, randomized, on 60 patients, randomized simple random sampling as a choice
Settings and conduct
Shahid Sadoughi and Shahid Rahnemoun Hospital in Yazd
Patients referred to the clinics of these two hospitals were randomly divided into case and control groups and intervened.
Participants/Inclusion and exclusion criteria
Patients with acute low back pain who were willing to participate in the study were included in the study, otherwise, they were not included in the study.
Intervention groups
Control; Treatment with three sessions a week of physiotherapy for one month
Case; Treatment with three sessions of laser therapy for one month
Main outcome variables
Achieving a minimally invasive procedure in acute low back pain caused by intervertebral disc herniation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210921052543N1
Registration date:2022-02-26, 1400/12/07
Registration timing:retrospective
Last update:2022-02-26, 1400/12/07
Update count:0
Registration date
2022-02-26, 1400/12/07
Registrant information
Name
Ehsan Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4097
Email address
elastnamejafari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-09-22, 1399/07/01
Trial completion date
2020-09-22, 1399/07/01
Scientific title
Comparison of the effectiveness of laser therapy and physiotherapy in reducing pain in patients with acute low back pain
Public title
Evaluating the effect of laser therapy in acute low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have a history of low back pain for at least 6 weeks
All patients with herniated disc pain
Use painkillers and rest while studying
The patients express their complete desire and satisfaction to enter this project
Exclusion criteria:
Failure to follow physiotherapy and laser therapy sessions for more than one session
The treatment plan is changed
The patient has other spinal complications
The patient has no willingness to continue participating in this project
The patient does heavy activities
Exit from rest mode
The patient has spinal canal stenosis
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization (patients select in blocks of 5)
Randomization unit: Person
Randomization tool: Sealed envelopes
To concealing random allocation will use Sequentially numbered, sealed, opaque envelopes (SNOSE).
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
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Ave. Prof. Hessabi, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.SSU.MEDICINE.REC.1400.109
Health conditions studied
1
Description of health condition studied
acute low back pain, physiotherapy, laser therapy, Oswestry Low Back Disability Questionnaire
ICD-10 code
M54.17
ICD-10 code description
Radiculopathy, lumbosacral region
Primary outcomes
1
Description
Visual Analogue Scale score, Oswestry Disability Index score, back rotation, and flexion score
Timepoint
Completion of the questionnaire at the beginning of the study and the time of the last treatment session
Method of measurement
Comparison of the effect of laser therapy on patient pain; Visual Analogue Scale score, comparison of the effect of laser therapy on the patient's back rotation and flexion; Score based on Likert classification
Secondary outcomes
1
Description
The Oswestry Disability Index
Timepoint
Completion of the questionnaire in the first and last session of treatment
Method of measurement
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire
Intervention groups
1
Description
Intervention group: Patients with laser therapy - 30 patients with acute low back pain are treated with laser therapy for one month. Treatment sessions are held every other day (15 sessions per month) and each session is 45 minutes.
Category
Rehabilitation
2
Description
Control group: patients with physiotherapy - 30 patients with acute low back pain are treated with physiotherapy for one month. Treatment sessions are held every other day (15 sessions per month) and each session is 45 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadougi Hospital
Full name of responsible person
Ehsan Jafari
Street address
Ave. IBne Sina, Shahid Sadoughi Hospital
City
Yazd
Province
Yazd
Postal code
Phone
+98 35 3822 4000
Email
elastnamejafari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Ave. Prof. Hesabi
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Fax
Email
masoud_mirzaei@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Sadoughi University of Medical Sciences, Yazd
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
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Jafari
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Prof. hessabi Ave
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3822 4097
Fax
Email
Elastnamejafari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Jafari
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Prof. hessabi Ave
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3822 4097
Fax
Email
Elastnamejafari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Ehsan Jafari
Position
Resident of Physical medicine and rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Prof. hessabi Ave
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3822 4097
Fax
Email
Elastnamejafari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD