Comparative effect of intra-articular Ozone injections with suprapatellar lateral and inferomedial approaches for pain control in patients with knee osteoarthritis
Comparative effect of intra-articular Ozone injections with suprapatellar lateral and inferomedial approaches for pain control in patients with knee osteoarthritis
Design
Double blind randomized clinical trial with control group, 60 patients sample size, Trial phase 2-3
Settings and conduct
In the tertiary regional and teaching hospital,among patients, candidates for ozone injection with suprapatellar lateral and inferomedial approaches refer to the Akhtar Hospital, after randomization, all procedures are performed using spinal needle 27 Gage.With ultrasonography guidanc,10 ml of ozone (15 μg / ml) is injected.Ozone injection is given up to three weeks, once a week.In these patients, pain in the portal area is measured by VAS (0-10). Disability based on Knee injury and Osteoarthritis Outcome Score questionnaire, is measured, which is completed in two steps before the start of treatment and three months after the last injection by the patient. Patients are asked to determine their pain levels before, one month and three months after the last injection. Complications are recorded.
Participants/Inclusion and exclusion criteria
Major eligibility criteria: Patients older than 40 years; The pain of knee osteoarthritis.
Major exclusion criteria: Degenerative Disc Herniation; History of Lumbar Spine Surgery
Intervention groups
Control group (inferomedial): The patient is placed in a supine position, It is characterized by knee flexion of about 45 to 30 degrees on the lateral side of the knee, landmark of the injection area is determined.
Intervention group (suprapatellar lateral): The patient is placed in a supine position, Insert the needle one centimeter high and one cm in the lateral portion of the super pellet margin with an angle of 45 ° in the direction of the cephalo lateral to the quadomedial, landmark of the injection area is determined.
Main outcome variables
Pain Level; Disability.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131124015515N5
Registration date:2019-03-14, 1397/12/23
Registration timing:registered_while_recruiting
Last update:2019-03-14, 1397/12/23
Update count:0
Registration date
2019-03-14, 1397/12/23
Registrant information
Name
Masoud Hashemi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 2252
Email address
dr.hashemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-10, 1397/12/19
Expected recruitment end date
2019-07-20, 1398/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of intra-articular Ozone injections with suprapatellar lateral and inferomedial approaches for pain control in patients with knee osteoarthritis
Public title
The effect of ozone injection with two different injection methods to control knee pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 40 years
The pain of knee osteoarthritis for more than three months
Radiological findings confirming knee osteoarthritis based on the American College of Rheumatology
Osteoarthritis with Grade II-III based on Kellgren-Lawrence radiology grading
No effusion
Signed written informed consent to participate in the study
Exclusion criteria:
Patients with history of knee surgery
Deformity and lower limb contraction
Lower limb neovascular disease
Acute lumbosacral pathology
Injection of steroid drugs over the past two months
History of inflammatory rheumatoid arthritis
Infection
Diabetes
Pregnancy
Breast feeding
Body Mass Index >35 kg/m2
Patients undergoing knee surgery
Knee deviation (verrucous or valgus more than 5 degrees) confirmed by three joint view
Radicular pain
Knee pain
Anticoagulant therapy
Post-traumatic arthritis
History of intraArticular or ozone therapy during 12 Last month
Systemic or psychiatric illness
Severe osteoarthritis with Grade over III
Age
From 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization based on random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant and clinical outcomes evaluator are not aware of the code assigned to each of the groups.
Placebo
Not 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 and Health Services
Street address
Tabnak St.,Tehran, Tehran, Iran, Islamic Republic Of
In the portal area during the first, second, third and fourth injections and knee pain before treatment, one month and three months after the last injection
Disability Level by Oswestry Low Back Disability Questionnaire
Timepoint
Before starting treatment and three months after the last injection
Method of measurement
Oswestry Low Back Disability Questionnaire that disability is measured with 10 items. Each item is scored from 5-0, which indicates a higher score for the disability.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: suprapatellar lateral approach، the patient is placed in a supine position, Insert the needle one centimeter high and one cm in the lateral portion of the super pellet margin with an angle of 45 ° in the direction of the cephalo lateral to the quadomedial, landmark of the injection area is determined.
Category
Treatment - Other
2
Description
Control group: Inferomedial approach، the patient is placed in a supine position, It is characterized by knee flexion of about 45 to 30 degrees on the lateral side of the knee, landmark of the injection area is determined.