Comparison of the effect of ozone-oxygen gas injection with high power laser in paravertebral muscles on pain and activity in patients with lumbar spinal canal stenosis
Design
Clinical trial with three control and intervention groups 1 and 2, double-blind, randomized simple block method, number of patients 28 in each group and a total of 84 cases
Settings and conduct
Study place: Patients who are referred to the physical medicine and rehabilitation clinic of Shahid Sadoughi hospital in Yazd, who have presented with spinal canal stenosis; Type of blinding: Double blind; How to blind: In this way, after selecting the patients, they are told that in all groups, the treatment methods were without complications and can reduce pain. The treatment can be placebo (normal saline), ozone-oxygen or high power laser. The patient and the treating physician are not aware of the nature of the treatment. Each patient and the drug used for him is identified by the same number. For example, patient number 8 and drug number 8.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent to participate in the study; neurological pain in the last six months; age 35-75 years; absence of any disease around the spine; no response to drug for more than 3 months.
Exclusion criteria: diabetes; history of spinal fractures; rheumatic diseases; allergic reactions to bovine proteins; pregnant women; history of previous spinal surgery; indication of emergency surgery
Intervention groups
Intervention group 1: Treated with medication, exercise and intramuscular ozone in paravertebral muscles.
Intervention group 2: Treated with medication, exercise and high power laser.
Control group: Treated with medication and exercise.
Comparison of ozone-oxygen gas injection and high power laser in paravertebral muscles on pain and activity in patients with lumbar spinal stenosis
Public title
The effect of ozone-oxygen gas on pain and activity in patients with lumbar spinal stenosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in the study
Existence of neurological pain and lameness in the last six months
Age between 35-75 years
Absence of any spinal or musculoskeletal disease
No response to drug treatment for more than 3 months
Exclusion criteria:
Diabetes mellitus
Body mass index more than 41
History of fracture of the spine
History of bleeding disorders
Rheumatic diseases
Neuropathy
Psychological diseases
Brucellosis
Genetic diseases such as galactose intolerance or lactase deficiency
Congenital heart diseases
Allergic reactions to bovine proteins
Inability to communicate
History of significant liver, kidney and heart disorders
Injections in or around the affected joint in the last six months
Pregnancy
Cancer
People who are taking anticoagulants
People with Favism
Vascular claudication
History of previous spinal surgery
Indication of emergency surgery
Any ban on ozone treatment
Any ban on acetaminophen
People consuming codeine
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
84
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the sample, they were randomly divided into three groups. In this study, individuals were assigned to three groups using permutation block method. In this method, A represents the person receiving the first intervention, B represents the person receiving the second intervention, and C represents the person receiving the placebo. Considering blocks of size 6, they were categorized into the desired permutations and patients were classified by random selection from the permutation envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
For the double blinding process, after selecting patients, they are told that in all groups, the treatment methods are uncomplicated and could reduce pain. The treatment can be placebo (normal saline), ozone-oxygen or high power laser. The patient and the treating physician are not aware of the nature of the treatment. Each patient and the drug used for him is identified by the same number. For example, patient number 8 and drug number 8.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
8915887856; Baqaei Pour Clinic; Shahid Sadoughi Hospital; Ibn Sina Blvd; Yazd
City
yazd
Province
Yazd
Postal code
8915887856
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.107
Health conditions studied
1
Description of health condition studied
lumbar spinal stenosis
ICD-10 code
M48.06
ICD-10 code description
Spinal stenosis, lumbar region
Primary outcomes
1
Description
Pain
Timepoint
Before treatment, immediately after treatment, and at weeks 4 and 8 after treatment
Method of measurement
Somatic symptom scale questionnaire
2
Description
Physical activity
Timepoint
Before treatment, immediately after treatment, and at weeks 4 and 8 after treatment
Method of measurement
Somatic symptom scale questionnaire
3
Description
Satisfaction
Timepoint
Before treatment, immediately after treatment, and at weeks 4 and 8 after treatment
Method of measurement
Somatic symptom scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: intramuscular paravertebral injection of oxygen –ozone with 10 microgram/cc - 3 times at week for 5 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: high intensity laser 30 W; dose 100 J / cm². 5 15-minute sessions per week for 2 weeks
Category
Treatment - Devices
3
Description
Control group: Exercises included lower trunk rotation; knee to chest; pelvic tilt, which strengthens and stabilizes the muscles of the abdomen, back and pelvis. All treatment groups were instructed to exercise three times a day for 2 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghaeipour clinic
Full name of responsible person
Samira Shahabi Rabori
Street address
8915887856; Baqaei Pour Clinic; Shahid Sadoughi Hospital; Ibn Sina Blvd; Yazd
City
Yazd
Province
Yazd
Postal code
8915887856
Phone
+98 35 3183 3004
Fax
+98 35 3822 9009
Email
baghaei@ssu.ac.ir
Web page address
http://ssu.ac.ir/cms/index.php?id=3022
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Masoud Mirzaei
Street address
Headquarters of Shahid Sadoughi University of Medical Sciences and Health Services; Dr. Shahid Bahonar Square; Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3822 9105
Email
baghaei@ssu.ac.ir
Web page address
http://ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Samira Shahabi Rabori
Position
Specialist Assistant in Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Baqaei Pour Clinic; Shahid Sadoughi Hospital; Ibn Sina Blvd; Yazd
City
Yazd
Province
Yazd
Postal code
8916884818
Phone
+98 35 3822 6575
Email
shahabi.867@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Samira Shahabi Rabori
Position
Specialist Assistant in Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Baqaei Pour Clinic; Shahid Sadoughi Hospital; Ibn Sina Blvd; Yazd
City
Yazd
Province
Yazd
Postal code
8916884818
Phone
+98 35 3822 6575
Email
shahabi.867@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Samira Shahabi Rabori
Position
Specialist Assistant in Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Baqaei Pour Clinic; Shahid Sadoughi Hospital; Ibn Sina Blvd; Yazd
City
Yazd
Province
Yazd
Postal code
8916884818
Phone
+98 35 3822 6575
Email
shahabi.867@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD