Goal: this study done to compare between anti inflammatory effects of two different doses of LLLT and NSAID therapy in patiants with acute LBP,Design:Double-blind, randomized, placebo-controled study.
Material &method: study performed in four groups of acute LBP with radiculopathy is associated with pain and disability,groupA is treated with analgesic dose of NSAID and active LLLT with 3 jole/cm2 ,GroupB with same doses of NSAID and active LLLT with 6 jole/cm2,Group C with placebo LLLT and same dose of NSAID and group D only NSAID therapy.
LLLT is applied behind the involved spine segments in six areas.patients treated 3 times per week for a total 12 treatments with following parameters, wavelength of 810 nm and doses of 3 and 6 jole/cm2. Outcome is pain intensity measured with visual analoge scale in lumbar and leg segments and ODI Questionaire of ADL. VAS measures before and after and with one week interval and ODI Qustionaire before and after treatments.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042713146N1
Registration date:2013-10-09, 1392/07/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-09, 1392/07/17
Registrant information
Name
Maryam Hayati
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 7180
Email address
m_hayati@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare between non steroid anti inflammatory drugs Therapy and Different Dosage of low level laser therapy in acute Low Back Pain
Public title
Compare between laser therapy and non steroid anti inflammatory drugs in acute low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of LBP less than 3 months; age range between 30-60 years old; no pregnancy; not having spinal surgery in recent years and not having systemic and psychological disorders
Exclusion criteria: spondylosis; spinal stenosis; ,malignant inflammatory disorders; smoking and addiction.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Bahonar bolvered, Qazvin University of Medical Sciences
City
Qazvin
Postal code
59811-34197
Approval date
2012-06-17, 1391/03/28
Ethics committee reference number
28/20/5985
Health conditions studied
1
Description of health condition studied
Acute low back pain
ICD-10 code
M51.2
ICD-10 code description
Other specified intervertebral disc displacement
Primary outcomes
1
Description
Pain
Timepoint
Before and after and with on week interval during treatment
Method of measurement
VAS scale
2
Description
Functional quality
Timepoint
Before and after intervention
Method of measurement
ODI questionaire
Secondary outcomes
empty
Intervention groups
1
Description
low level laser therapy with 3,6 joles on cm2 and placebo intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical center of Qazvin University of Medical Sciences
Full name of responsible person
Dr Mahnaz Abbasi
Street address
opposite of Mehregan hospital,ferdosi avenue
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mahnaz Abbasi
Street address
vice-chancellor research,Qazvin University of Medical Sciences
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Hayati
Position
PhD candidate
Other areas of specialty/work
Street address
Number 2,floor 1, Ferdoosi medical center, Qazvin
City
Qazvin
Postal code
3413679138
Phone
+98 28 1223 5988
Fax
Email
m_hayati@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Hayati
Position
PhD candidate
Other areas of specialty/work
Street address
Number 2, floor 1,Ferdoosi medical bulding, Ferdoosi avenue
City
Qazvin
Postal code
3413679138
Phone
+98 28 1223 5988
Fax
Email
m_hayati@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Hayati
Position
PhD
Other areas of specialty/work
Street address
Number 2,floor 1, Ferdoosi medical bulding, Ferdoosi avenue
City
Qazvin
Postal code
3413679138
Phone
+98 28 1223 5988
Fax
Email
m_hayati@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)