Comparison of the effects of paraspinal ozone injection and physiotherapy in chronic non-radicular low back pain
Design
It is a randomized clinical trial with parallel groups , the study population of 64 patients referred to Firoozgar and Rasoul Akram hospitals.
Settings and conduct
The study population is patients referred to the clinic of physical medicine and rehabilitation of Firoozgar and Rasoul Akram hospitals in Tehran .Patients whose complaints are chronic non-radicular low back pain are examined and approved by a physical medicine and rehabilitation specialist, and if there are inclusion criteria, after completing the consent form, they are randomly admitted to one of the injection or physiotherapy groups.This study will be performed as a follow-up for one month and three months .
Participants/Inclusion and exclusion criteria
Inclusion criteria : patients complaining of chronic non-radicular low back pain.
Exclusion criteria : radicular low back pain and neurological symptoms, patients who have undergone injections of any drug or acupuncture for the lower back in the past three months, and fractures, tumers, infections
Intervention groups
Intervention group: Ozone injection is done in three sessions in such a way that 10 cc of ozone (15 micrograms) with 2 cc of lidocaine with needle G 22 with lateral approach of 2 cm spinus process routinely at maximum tolerance points (Multi level treatment one level Above and below the affected surface) or the paraspinal resuscitation area of both sides is injected in area 4 L5-L and L5-S1. After the injection, it is recommended to do exercise at home.
Control group: undergoes 10 sessions of physiotherapy, which includes surface and deep heat, infrared lamp, tens and exercise.
Main outcome variables
Visual analog Scale , Evaluate daily activities
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201128049512N1
Registration date:2020-12-14, 1399/09/24
Registration timing:prospective
Last update:2020-12-14, 1399/09/24
Update count:0
Registration date
2020-12-14, 1399/09/24
Registrant information
Name
Mahdieh Saki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1000
Email address
saki.ma@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of paraspinal ozone injection and the effects of physiotherapy on chronic non-radicular low back pain
Public title
Comparison of the effects of paraspinal ozone injection and the effects of physiotherapy on chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
chronic low back pain for more than 6 weeks
nonradicular chronic low back pain
Age 20 to 60 years
VAS is more than equal to 4
No contraindications to injections
No contraindications to physiotherapy
Failure to perform epidural and paraspinal injections in the last three months
Failure to respond to medical treatment for more than two weeks
The patient's desire to participate in the research project
Exclusion criteria:
Radicular pain
Neurological signs and symptoms that indicate nerve root involvement
Vascular malformation
Tumor
Fracture
Infection
Diffuse idiopathic skeletal hyperstosis
Injectable treatment with any type of medication or acupuncture for the lower back during the last three months
History of spinal surgery
Bleeding disorders or the use of anticoagulants and hemorrhages other than aspirin
Topical allergy to anesthetics
pregnancy
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: block
Randomization unit: individual
Randomization tool: Random number tables
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 Iran University of Medical Sciences
Street address
School of Medicine, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-11-04, 1399/08/14
Ethics committee reference number
IR.IUMS.FMD.REC.1399.469
Health conditions studied
1
Description of health condition studied
Nonradicular chronic low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Visual analog scale
Timepoint
Before ozone injection and physiotherapy, After doing it, one month and three months later
Method of measurement
VAS ruler
2
Description
Evaluate daily activities
Timepoint
Before injection and physiotherapy and three months after injection and physiotherapy
Method of measurement
Modified Oswestry questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection of 10 cc of ozone (15 micrograms) with 2 cc of lidocaine in the paraspinal region of both sides with needle 22-G in completely sterile conditions with lateral approach 2 cm spinus process routinely in the paraspinal region on both sides of maximum tenderness points (Multi level treatment Level up and down the affected surface or in areas 4 L5-L and L5-S1. The injection is given three times a week.
Category
Treatment - Drugs
2
Description
Control group:undergo 10 sessions of physiotherapy for 3 weeks, which includes surface and deep heat, infrared lamp, tens and exercise.