Objectives: The aim of this study is the Assessment of the effectiveness of low level laser therapy on the post-operative pain in the patient with lumbar disk herniation . Design: Randomized clinical trial. Setting and Conduct: We study 60 patients referring for lumbar disc herniation surgery to Tabriz SHohada hospital in the form of two equal groups . Patients will randomly be assigned into one of two groups. We use Low Level Laser for one group and routine analgesic drugs for the other group, the pain in the patients was assessed by Visual Analogue Scale(VAS) in each group and was compared to each other. Participants including major eligibility criteria: Patients referring for lumbar disc herniation surgery at the age range of 20 to 50 years will enroll into the study. Patients with chronic usage of any drugs, history of diabetes, surgical infectious wound due to any reason and history of relapsed herniation will be excluded. Intervention: After randomly assigning into two groups we use low level laser therapy for one group and routine nalgesic drugs for the other group. Main outcome measures (variables):Post operative pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052612853N1
Registration date:2013-07-01, 1392/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-01, 1392/04/10
Registrant information
Name
Mohammad Shimia
Name of organization / entity
Tabriz University of Medical Sciences and Health services
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 7774
Email address
shimia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-12-20, 1391/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effectiveness of low level laser therapy on the post-operative pain in the patient with lumbar disk herniation
Public title
Assessment of the effectiveness of low level laser therapy on the post-operative pain in the patient with lumbar disk herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-Being at the age between 20-50 years; 2-Consent for the research. Exclusion criteria: 1-History Diabetes; 2-History of chronic usage of any drug in the past 6 months; 3-Patients undergoing the surgery due to relapse of lumbar disc herniation; 4-Patients with surgical infectious wound due to any cause.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tabriz University of medical sciences and health services
Street address
Central office of Tabriz university of medical sciences, Golgasht street, Azadi street.
City
Tabriz
Postal code
5165687386
Approval date
2012-11-11, 1391/08/21
Ethics committee reference number
91130
Health conditions studied
1
Description of health condition studied
post operative pain
ICD-10 code
Y83.9
ICD-10 code description
Surgical procedure, unspecified
Primary outcomes
1
Description
Post operative pain
Timepoint
3 hours, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours, 1 month, 2 months and 3 months after the surgery
Method of measurement
Visual analogue scale(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Laser irradiation will be done using a low level laser device mustang-026-Bio close to wound,10 minutes each time.
Category
Treatment - Other
2
Description
Control group: The analgesic treatment will be done using routine analgesic drugs
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam Reza Hospital
Full name of responsible person
Dr.Mohammad Shimai
Street address
Imam Reza hospital, Golgasht street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reserach, Tabriz university of medical sciences
Full name of responsible person
Seyed Kazem Shakouri
Street address
Golgasht street, Daneshgah street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reserach, Tabriz 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
Tabriz faculty of Medicine, Tabriz university of medical sciences