Evaluation of the effect of 808 nm diode laser (160 mw) on Low back pain (LBP) compared to Naproxen
Design
A randomized, single blind, sham controlled clinical trial with a parallel group design of 40 patients
Settings and conduct
This study was conducted on 40 patients with mechanical low back pain in two groups, the intervention group and the control group. Subjects in both groups were prescribed naproxen per need. Patients in the intervention group received 12 sessions of laser therapy with a 808 nm diode laser. the control group attended 12 sessions of sham laser therapy. The device was the same, but it was off during treatment sessions. Patients´ demographic characteristics, pain severity, and functional status were obtained and documented in a preliminary visit. At the end of the first and third months after the treatment and all the above-mentioned items were reassessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: LBP (low back pain) patients
Exclusion criteria: radiculopathy
Intervention groups
The patients in the present study were randomly assigned to two groups. Each group consisted of 20 Patients. both groups were prescribed naproxen per need (up to 1000 mg daily). 1) The intervention (true laser) group received 12 sessions of laser therapy with the frequency of 3 sessions per week. Laser characteristics were as follows: diode laser, wavelength 808 nm, power 160 mW
2) The control (sham laser) group attended 12 sessions of sham laser therapy. The device was the same, but it was off during treatment sessions.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111121008146N32
Registration date:2020-01-10, 1398/10/20
Registration timing:retrospective
Last update:2020-01-10, 1398/10/20
Update count:0
Registration date
2020-01-10, 1398/10/20
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
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
2012-02-20, 1390/12/01
Actual recruitment end date
2012-05-21, 1391/03/01
Trial completion date
2012-10-22, 1391/08/01
Scientific title
Comparison of the effectiveness of an 808 nm diode laser (160 mv) with Naproxen in reducing the pain in mechanical low back pain patients
Public title
comparison of the effect of a low level diode laser with Naproxen on low back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
complaint of chronic mechanical low back pain (more than 3 months)
pain severity : 3-10 according to the visual analogue scale of pain (VAS)
at least 20 years old
signing the written informed consent
Exclusion criteria:
Radiculopathy
Subjects with a history of motor or sensory deficits
Pregnancy
NSAIDs-induced serious gastrointestinal problems such as bleeding/perforation
a need to emergent/urgent surgery
malignancy
active gastric ulcers
aspirin sensitivity
Rheumatologic diseases
undertreated severe depression
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization table was used. A series of numbers were selected. even numbers and odd numbers were allocated to the intervention group and control group respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients were randomly assigned to two groups, the intervention (true laser) and the control (sham laser).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2011-12-11, 1390/09/20
Ethics committee reference number
85248/د/1398- 1398/08/20
Health conditions studied
1
Description of health condition studied
Mechanical low back pain
ICD-10 code
M54.5
ICD-10 code description
low back pain
Primary outcomes
1
Description
pain severity ( from 0 to 10) based on visual analogue scale
Timepoint
Evaluation of low back pain severity before intervention and at the end of the first and third months after the treatment
Method of measurement
visual analogue scale
2
Description
functional status
Timepoint
evaluation of the functional status before the intervention and at the end of the first and third months after the treatment
Method of measurement
Ronald-Morris disability questionnaire (RMDQ)
3
Description
Anterior and lateral flexion range of motion (ROM) of vertebral column in Cm
Timepoint
Before the intervention and at the end of the first and third months after the treatment
Method of measurement
Physical examination
4
Description
spinal tenderness
Timepoint
Before the intervention and at the end of the first and third months after the treatment
Method of measurement
Physical examination
Secondary outcomes
1
Description
patients´ satisfaction with the treatment process
Timepoint
At the end of the first and third months after the treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Subjects took the protective instructions and were prescribed naproxen per need (up to 1000 mg daily). Patients received 12 sessions of laser therapy with the frequency of 3 sessions per week. Laser characteristics were as follows: Infrared laser GaAlAs,wavelength 808 nm, power 160 mW and penetration depth of 4 cm.We applied the laser to articular spaces of vertebral column (3 points on each disc, each one for 30 seconds , 4.5 j/cm² on each point), adjacent paravertebral points (1 point on each side, 30 seconds, 4.5 j/cm² on each point), pain radiating areas and tender points (at least 12 points, with the dosage of 4.5 J/cm2) and also pain-controlling acupuncture points (LI4, ST44, H7) with the dosage of 1.5 J/cm2 (10 seconds on each point).
Category
Treatment - Other
2
Description
Control group: Subjects took the protective instructions and were prescribed naproxen per need (up to 1000 mg daily). Patients received 12 sessions of sham laser therapy with the frequency of 3 sessions per week as described in intervention group. The device was the same as the intervention group, but it was off during treatment sessions.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Mohammad Reza Razaghi
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Next to Ayatollah Taleghani Hospital, Shahid Arabi ST. Yemen street, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamadreza razaghi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Shohada Hospital-Tajrish
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Reza Razaghi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Reza Razaghi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Shohadaye Tajrish Hospital, Tajrish, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2274 9221
Email
laser.cntr@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available