Therapeutic affects Low Power Laser on distraction of this part of bone due to AVN of Femoral Head
Design
This is an interventional quasi-experimental study whit simple randomized method. 32 patients undergo laser therapy.
Settings and conduct
This study will be carried out at Firoozgar Hospital in Tehran. The laser is transmitted through the skin of the hip joint anatomical area during the 9 courses (while each course consists of 10 sessions). This research does not require blinding.
Participants/Inclusion and exclusion criteria
Participants that fall within categories 1 and 2 of the ASA are admitted to the study. They are patients of both sexes, diagnosed with AVN of femoral head (grade 4- 3) and range from 40 to 18 years old.
Exclusion criteria: Contraindication for using a laser
Intervention groups
The therapeutic laser characteristics includes:
Two types of red (200 MW) and IR (300 MW) lasers transmit through the skin on the anatomical site of the hip joint. The maximum fluence (energy) is 30 J/cm2 on 15 points for each joint.
Main outcome variables
Visual Analogue Scale, Range of Motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180305038955N1
Registration date:2018-07-25, 1397/05/03
Registration timing:registered_while_recruiting
Last update:2018-07-25, 1397/05/03
Update count:0
Registration date
2018-07-25, 1397/05/03
Registrant information
Name
Aliakbar Jafarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1612
Email address
aajafari41@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of the local low-power laser therapy on clinical and imaging alterations in patients with avascular necrosis of femoral head
Public title
Evaluation the influence of the local low-power laser therapy in patients with avascular necrosis of femoral head
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients from both sexes were entered into the study with grade 1 and 2 on the basis of the American Society of Anesthesiology criteria. The participants were diagnosed as avascular necrosis of femoral head (grade 3-4) based on the diagnostic criteria of the Massachusetts hospital.
Age range 18-40 years
Exclusion criteria:
Patients who tend to have surgery
Grade 1,2 ,5 and 6 of American Society of Anesthesiologists (ASA) Radiologic Criteria for Femoral head AVN
patients were not intended to be treatde
Malignancy in the vicinity of the treatment area
Dermatologic problems which makes the treatment impossible
Other invasive or Non-invasive treatments on the affected area
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-12-17, 1396/09/26
Ethics committee reference number
IR.IUMS.REC 1396.31422
Health conditions studied
1
Description of health condition studied
Avascular Necrosis of Femoral Head
ICD-10 code
M87.159
ICD-10 code description
Osteonecrosis due to drugs, unspecified femur
Primary outcomes
1
Description
Pain
Timepoint
Measure of pain at the beginning of the study (before the intervention) and after each 10-session of treatment period
Method of measurement
Visual Analogue scale (VAS)
2
Description
Hip motion range
Timepoint
Measure of pain at the beginning of the study (before the intervention) and after each 10-session of treatment period
Method of measurement
Range of Motion
Secondary outcomes
empty
Intervention groups
1
Description
In this study, the laser fluence (energy) is transmitted through the skin to the anatomical location of the affected hip (15 points for each joint). The periods of radiations include 9 courses (each course consists of 10 sessions) and a total of 90 sessions over a period of 9 months. The Selected points are those which is recommended in guidelines for acupuncture procedures to control hip pain. The recommended lasers are RED (200 mw) and IR (300 mw) and the maximum fluence (energy) is 30 joules per centimeter squared (30 J/cm2). The laser therapy schedules in each period are ten sessions every two days with a week interval and then the next period will start again
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Aliakbar Jafariyan
Street address
Firoozgar Hospital, Behafarin Avenue
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 8214 1612
Email
aajafari41@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Kazem Malakooti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 5503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Aliakbar Jafariyan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Firoozgar Hospital, Behafarin Avenue
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 8214 1612
Email
aajafari41@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aliakbar Jafariyan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Firoozgar Hospital, Behafarin Avenue
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 8214 1612
Email
aajafari41@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Aliakbar Jafarian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Firoozgar Hospital, Behafarin Avenue
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 8214 1612
Email
aajafari41@gmail.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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available