Goal: this study done to compare between anti-inflammatory effects of two different frequency of pulse low level laser therapy with dose of 6 j/cm2 and NSAID therapy in patients with acute LBP. Design: Double-blind, randomized, placebo-controlled study.
Material & method: study performed in four groups of acute LBP with radiculopathy is associated with pain and disability; group A is treated with analgesic dose of NSAID and active pulse low level laser therapy with frequency of 10 Hz and dose of 6 j/cm2, group with same doses of NSAID and active pulse low level laser therapy with same dose with frequency of 250 Hz; group C with placebo LLLT and same dose of NSAID and group D only NSAID therapy. LLLT with same dose but with two different frequency 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 dose of 6 j/cm2 with frequencies of 10 and 250 hz .outcome is pain intensity measured with visual analogue scale in lumbar and leg segments and ODI questionnaire of ADL. VAS measures before and after and with one week interval and ODI questionnaire before and after treatments.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052213146N2
Registration date:2013-12-15, 1392/09/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-15, 1392/09/24
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
2013-11-22, 1392/09/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare between non steroid anti inflammatory drug and Different Frequency of pulse low level laser therapy in acute Low Back Pain
Public title
Compare between pulse lasertherapy and none steroid antiinflamatory drug in acute low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: LBP less than3 months; age range between 30-60 years old; not pregnant; have not spinal surgery in recent years; have not 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
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar bolverd
City
Qazvinq
Postal code
59811-34197
Approval date
2012-06-25, 1391/04/05
Ethics committee reference number
28/20/6035
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 weekly during treatment
Method of measurement
VAS scale
2
Description
Functional quality
Timepoint
Before and after
Method of measurement
ODI questionaire
Secondary outcomes
empty
Intervention groups
1
Description
6 j/cm2 low level laser therapy with frequency of 10 hz and NSAID therapy with analgesic dose
Category
Other
2
Description
placebo low level laser therapy and NSAID therapy with analgesic dose
Category
Placebo
3
Description
6 j/cm2 low level laser therapy with frequency of 250 hz and NSAID therapy with analgesic dose
Category
Treatment - Other
4
Description
NSAID therapy with analgesic dose s a control group
Category
Treatment - Drugs
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 for 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 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
Sharing plan
Deidentified Individual Participant Data Set (IPD)