we designed this study to evaluate the effect of low level laser therapy in some other musculoskeletal disorders and importance of low back pain. Our study was a one side blind, randomized controlled trial. 40 subjects with low back pain entered the study. Patients were aged between 20-70 and their pain severity scale was 3-10 according to visual analogue scale of pain .They were randomly assigned in two groups: true laser and control (sham laser). Naproxen was prescribed with a free dose (250- 1000 mg/daily) in both groups. We evaluated patients’ subjective pain, functional status (using Roland Morris disability questionnaire), spinal tenderness at the basic time, one and three months post- treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201711058146N28
Registration date:2017-11-05, 1396/08/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-05, 1396/08/14
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Laser Application Research Center in Medical Sciences - Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Low Level Laser Therapy on Mechanical LBP(without radiculopathy) with Naproxen
Public title
Comparing the effect of Low Level Laser Therapy on low back pain with Naproxen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being over the age of; A written consent form has been signed; VAS level is between 10-3; According to the expert's diagnosis, the cause of their lower back pain is mechanical and lack of radiculopathy; Their lower back pain is more than three months; Exclusion criteria: Patients requiring emergency surgery:Bladder symptoms such as bladder loss, bladder loss, incontinence, lack of Sense while passing urine, Stomach incontinence , Anesthetizing around the anus ; Pregnancy; Discontinuation of the drug prescribed in / out of the protocol for the administration of the drug; A history of serious gastrointestinal complications (perforation / bleeding) due to the use of various types of NSAIDs; Being / detecting any type of cancer 6 patients with heart problems; Patients who have spinal cord stenosis;Radiculopathy (Pulmonary to subcutaneous pain); Sensory impairment; Muscle weakness; Patients who have taken rococtane over the past 3 months; Patients with asthma, allergic to aspirin or nasal polyps; Patients with severe depression and not being treated; Patients with psychosis;
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Organizational committee of ethics in biomedical research Shahid Beheshti University of Medical Scie
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Postal code
Approval date
2011-12-11, 1390/09/20
Ethics committee reference number
IR.SBMU.RETECH.REC.1390.109
Health conditions studied
1
Description of health condition studied
Mechanical LBP(without radiculopathy)
ICD-10 code
G54.1
ICD-10 code description
Lumbosacral plexus disorders
Primary outcomes
1
Description
The degree of disability patients
Timepoint
One month after the treatment and the end of the third month
Method of measurement
Ronald-Morris Questionnaire and Oswestry Standard
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For a period of one month, the lasers are powered by a 808nm diode laser device with a power supply of 160 mW, and the lumbar, trigger points, thunder points, and some acupuncture points will be exposed. Naproxen A dosage of 250-2000 mg per day is administered free of charge (ie, if appropriate), and the daily intake is recorded in a table.
Category
Treatment - Other
2
Description
Control group: One month is used in the laser. Naproxen is given at a dose of 1000-250 mg daily for free (ie, if necessary) intake and daily intake is recorded in a table
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Laser Application Research Center in Medical Sciences
Full name of responsible person
Dr.Leila Kholoosi
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shahid Beheshti 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
Laser Application Research Center in Medical Science
Full name of responsible person
Dr.Leila Kholoosi
Position
MD
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
Lilykh.md2537@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Darush Eliaspoor
Position
Physical medicine & rehabilitation specialist
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
d.eliaspour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Laser Application Research Centre in Medical Sciences
Full name of responsible person
Dr.Leila Kholoosi
Position
MD
Other areas of specialty/work
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Postal code
Phone
+98 21 2274 9221
Fax
Email
Lilykh.md2537@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)