Comparing the effectiveness of intramuscular paravertebral injection of Oxygen –Ozone and epidural injection of Hyaluronidase on pain and function in patient with lumbosacral canal stenosis
Effectiveness of Epidural Hyaluronidase Injection and Comparison with Ozone Muscle Injection to Reduce Pain and Improve Function in Patients with Lumbosacral Spinal Stenosis
Design
Clinical trial with control group, with parallel groups, triple-blind, randomized through block randomization method
Settings and conduct
Patients are initially divided into two groups, and after obtaining written consent, the study begins. Treatment in one group involves injecting a mixture of Ozone-Oxygen in the paravertebral muscles.
Injections are performed three times with interval of one week at the Physical Medicine and Rehabilitation Clinic in Haj Ismail Emtiaz Hospital.
In the second group, treatment consists of injecting a single-dose epidural Hyalase _1500 unit under a Fluoroscopic-guided epidural injection.
In this study, blinding in patients, health care providers and statistical consultant was done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Back pain and other symptoms of spinal canal stenosis in the last six months Age between 35_75 years
Confirmation of spinal canal stenosis through MRI and EDX. Non-inclusion criteria: Diabetes Melitus;
Rheumatologic and collagen vascular diseases;
peripheral neuropathy and nerve injury;
Brucellosis.
Intervention groups
Intervention group: Ozone treatment group. Injection of 18 ml of Ozone-Oxygen mixture (2% _98%) at a concentration of 20 µg / dl at six points (three cc each point) in the paravertebral muscles. Control group: Hyaluronidase treatment group. Injection of a Hyaluronidase_1500 unit unit and 4 cc Marcain by Epidural-guided fluoroscopy in Epidural space
Main outcome variables
Pain and Activity of Daily Living
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191004044980N1
Registration date:2019-11-25, 1398/09/04
Registration timing:registered_while_recruiting
Last update:2019-11-25, 1398/09/04
Update count:0
Registration date
2019-11-25, 1398/09/04
Registrant information
Name
Reyhane Parvin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5364 2641
Email address
reyhaneh.parvin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of intramuscular paravertebral injection of Oxygen –Ozone and epidural injection of Hyaluronidase on pain and function in patient with lumbosacral canal stenosis
Public title
The effect of Hyaluronidaz and Ozon on spinal canal stenosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Back pain and other symptoms of spinal canal stenosis in the last six months
Age between 35_75 years
Confirmation of spinal canal stenosis through MRI and EDX
Exclusion criteria:
Diabetes Melitus
Rheumatologic and collagen vascular diseases
peripheral neuropathy and nerve injury
Brucellosis
BMI more than 41
History of trauma and spinal fracture
Bleeding disorder
Allergic reaction to Bovin protein
Genetic disease such as Galactose intolerance or Lactase deficiency
Patient with cardiac problem
Inability to communicate and complete the questionnaire
History of liver ,kidney and cardiopulmonary problem
History of periarticular or intraarticular in the past 6 months
Pregnant women
People with cancer
People taking Anticoagulant
Favism
Age
From 35 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Complete randomized block design with SPSS software is used for randomization and then sealed non-transparent envelopes are used to hide the random sequence.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant:The participant is explained that if they are interested, they can join our research project. Two methods used to reduce patient pain in our study are explained to the patient. Benefits and possible complications of both methods are described to the patient and the patient is told to randomly fall into one of the intervention groups. If the patient is accepted to admit the study, by random allocation software, the patient falls into one of two groups
Clinical Caregiver: We teach the caregiver how to complete the questionnaire. This person is not aware of the patient's intervention.
Researcher: In this study we are not capable of blinding the researcher because the researcher performs both interventions himself and is aware of any intervention in each group.
Outcome Assessor: Completed questionnaires are handed to a person who is unaware of interventions and requested to determine the extent of pain reduction and performance enhancement in each individual according to the questionnaire.
Data analyzer: Questionnaires are finally given to the individual after completing and collecting all the information to evaluate the information. This person is unaware of any of the steps in the study and group division and intervention allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Science
At baseline (before intervention), 2, 4 and 8 weeks after injection
Method of measurement
Visual Analog Scale
2
Description
Patient Performance Score in Oswestry Disability Scale
Timepoint
At baseline (before intervention), 2, 4 and 8 weeks after injection
Method of measurement
Oswestry Low Back Pain Questionnaire
3
Description
Patient Performance Score in QUEBEC Back Pain Disability
Timepoint
At baseline (before intervention), 2, 4 and 8 weeks after injection
Method of measurement
QUEBEC Back Pain Disability Qestionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of 18 cc Ozone-Oxygen mixture (2% _98%) at a concentration of 20 µg / dl at six points (three cc in each point) in the paravertebral muscles at 2 cm from the lumbar spine 4 and 5 and the first sacral vertebrae are injected through the nidel thin gage 22 at an angle of about 90 degrees to the sagittal plate, for three sessions at a interval of one week.
Category
Rehabilitation
2
Description
Control group: a single unit of hyaluronidase-1500 unit and 4 cc marcain 0.5% is injected epidurally under fluoroscope-guided epidural injection. The injection is done only one time.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation Clinic of Shahid Rajaee Hospital in Shiraz
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All available data can be shared after making people unidentifiable
When the data will become available and for how long
Start access period one year after publishing the results
To whom data/document is available
Everyone can access to this information
Under which criteria data/document could be used
If the information in this study helps to improve the science process.
From where data/document is obtainable
reyhaneh.parvin@gmail.com
00989171324770
What processes are involved for a request to access data/document
After sending the desired message, all authors of the study will be consulted and all information will be sent within a maximum of three weeks if permitted.