Low Back Pain, Posterior CompartmentNCT05586633
The Efficacy of Ultrasound-guided Ozone Injection in the Treatment of Patients With Chronic Low Back Pain
A study testing deep paravertebral periforaminal ozone injeciton and transforaminal steroid injeciton in people with Low Back Pain, Posterior Compartment, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is a common disorder that every individual in the society is likely to meet throughout his/her life. Low back pain lasting longer than 12 weeks is defined as chronic low back pain and causes serious disability in the community. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Posterior Compartment
- What is being tested?
- deep paravertebral periforaminal ozone injeciton and transforaminal steroid injeciton
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Back and leg pain lasting longer than 3 months
- Diagnosis of lumbar disc herniation with advanced imaging techniques after anamnesis, - physical examination and laboratory examinations
- Continuation of complaints despite conservative treatment before
- Regular participation in the study voluntarily
Who cannot join
- Being pregnant and breastfeeding
- History of lomber surgery
- Peripheral neuropathy (diabetes, alcoholism...)
- Cauda equina syndrome or progressive neurologic deficit in the lower extremity
- Neurogenic bladder/bowel syndrome
- Arterial vascular disease-Vascular claudication
Show all 15Show fewer
- Spinal stenosis, spondylolysis, spondylolisthesis
- Local infection at the injection site
- Presence of bleeding diathesis
- Neuro-degenerative diseases
- Uncontrolled diabetes, hypertension
- History of malignancy
- Uncontrolled psychiatric illness
- BMI over 40
- Allergy to injection substances
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
esra ülgen kıratlıoğlu, +905079614194, esraulgen@gmail.com
kutay tezel
About this study
Official title: The Efficacy of Ultrasound-guided Deep Paravertebral-periforaminal Ozone Injection in the Treatment of Patients With Chronic Low Back Pain
Low back pain is a common disorder that every individual in the society is likely to meet throughout his/her life. Low back pain lasting longer than 12 weeks is defined as chronic low back pain and causes serious disability in the community. Conservative, pharmacological, interventional and surgical treatment options are available in its treatment. In this study, it was aimed to determine the effects of ultrasound-guided deep paravertebral periforaminal ozone injection treatment on physical examination, functional independence, quality of life and pain scores in patients with chronic low back and leg pain and to compare it with transforaminal epidural steroid injection treatment.
Read the detailed description
A total of 50 patients were included in the study. Deep paravertebral periforaminal ozone injection was administered to the patients in the ozone injection group 4 times under ultrasound guidance, 10 ug/ml 5ml twice a week in the first week and 15 ug/ml 5ml twice a week in the second week. In the transforaminal epidural steroid injection group, steroid (dexamethasone 8mg/2ml 2ml) injection was performed under the guidance of fluoroscopy. The patients in both groups were offered a home exercise program for therapeutic waist and abdominal muscles to do during the treatment follow-up period. Patients\' quality of life was evaluated with SF-36(Short Form-36), pain scores with VAS(Visüel Analog Scala) and functional evaluations with ODI(Oswestry Disability Index) at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.
- Conditions
- Low Back Pain, Posterior Compartment
- Being tested
- deep paravertebral periforaminal ozone injeciton, transforaminal steroid injeciton
- Keywords
- Low Back Pain, periforaminal ozon injection, transforaminal steroid injection, ultrasound guided injection
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep paravertebral periforaminal ozone injecitonProcedure or surgery
Deep paravertebral periforaminal ozone injection was administered to the patients in the ozone injection group 4 times under ultrasound guidance, 10 ug/ml 5ml twice a week in the first week and 15 ug/ml 5ml twice a week in the second week.
Patients will be evaluated according to the study criteria at the beginning, at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.
transforaminal steroid injecitonProcedure or surgery
Transforaminal epidural steroid injection group, steroid (dexamethasone 8mg/2ml 2ml) injection was performed under the guidance of fluoroscopy.
Patients will be evaluated according to the study criteria at the beginning, at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| deep paravertebral- periforaminal ozone injection | Active comparator | Not described Receives: Procedure: deep paravertebral periforaminal ozone injeciton |
| transforaminal steroid injeciton | Active comparator | Not described Receives: Procedure: transforaminal steroid injeciton |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAİN-Visual Analog Scala (VAS)
Visual Analog Scala (VAS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Severity of pain was assessed VAS using the standard 10 cm (back pain and leg pain) with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end.
Measured: 2nd week, 4th week, 8th week pain change
Quality of life - Short Form-36 (SF-36)
Satisfaction assessed by the SF-36. Short Form (SF-36) was used to investigate the quality of life of the patients.The reliability and validity of the Turkish version of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores show better Quality of life.
Measured: 2nd week, 4th week, 8th week quality of life change
Oswestry Disability Index (ODI)
In the ODI questionnaire, the effect of low back pain on activities of daily living is questioned. In the test, which consists of 10 questions in total, the patient's pain intensity, the effects of pain on personal care, walking, lifting weights, standing, sitting, sleeping, sexual life, social life and traveling are questioned. The patient can get a minimum of 0 and a maximum of 5 points from each question. The maximum score to be taken from the test is 50. The patient's score is found by dividing the total score of the patient by 50, which is the maximum score, and calculating the percentage. (Patient's score ÷ maximum score × 100). Accordingly, it is calculated how much the patient's life activities are affected.
Measured: 2nd week, 4th week, 8th week pain change
Physical examination-Lumbar joint range of motion examination
Lumbar joint range of motion examination( flexion-extansion-lateral flexion-rotation)
Measured: 2nd week, 4th week, 8th week examination change
Physical examination-straight leg raise test
straight leg raise test- It is recorded whether there is normal or abnormal
Measured: 2nd week, 4th week, 8th week examination change
Physical examination-femoral nerve stretch test
femoral nerve stretch test - It is recorded whether there is normal or abnormal
Measured: 2nd week, 4th week, 8th week examination change
Physical examination-Walleix palpation
Walleix palpation- It is recorded whether there is tenderness in Walleix palpation.
Measured: 2nd week, 4th week, 8th week examination change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Nov 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, Posterior CompartmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sefa Gümrük Aslan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586633
- Sponsor's protocol ID
- 32
- Status last verified
- Oct 2022
- First submitted
- 14 Aug 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasound-guided Deep Paravertebral-periforaminal Ozone Injection in the Treatment of Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05586633
- Acronym / sponsor ID
- 32
- Conditions
- Low Back Pain, Posterior Compartment
- Keywords
- Low Back Pain, periforaminal ozon injection, transforaminal steroid injection, ultrasound guided injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain is a common disorder that every individual in the society is likely to meet throughout his/her life. Low back pain lasting longer than 12 weeks is defined as chronic low back pain and causes serious disability in the community. Conservative, pharmacological, interventional and surgical treatment options are available in its treatment. In this study, it was aimed to determine the effects of ultrasound-guided deep paravertebral periforaminal ozone injection treatment on physical examination, functional independence, quality of life and pain scores in patients with chronic low back and leg pain and to compare it with transforaminal epidural steroid injection treatment.
Detailed description
A total of 50 patients were included in the study. Deep paravertebral periforaminal ozone injection was administered to the patients in the ozone injection group 4 times under ultrasound guidance, 10 ug/ml 5ml twice a week in the first week and 15 ug/ml 5ml twice a week in the second week. In the transforaminal epidural steroid injection group, steroid (dexamethasone 8mg/2ml 2ml) injection was performed under the guidance of fluoroscopy. The patients in both groups were offered a home exercise program for therapeutic waist and abdominal muscles to do during the treatment follow-up period. Patients\' quality of life was evaluated with SF-36(Short Form-36), pain scores with VAS(Visüel Analog Scala) and functional evaluations with ODI(Oswestry Disability Index) at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep paravertebral- periforaminal ozone injection | Active comparator | Procedure: deep paravertebral periforaminal ozone injeciton |
| transforaminal steroid injeciton | Active comparator | Procedure: transforaminal steroid injeciton |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Back and leg pain lasting longer than 3 months
- Diagnosis of lumbar disc herniation with advanced imaging techniques after anamnesis, - physical examination and laboratory examinations
- Continuation of complaints despite conservative treatment before
- Regular participation in the study voluntarily
Key exclusion criteria (15 listed)
- Being pregnant and breastfeeding
- History of lomber surgery
- Peripheral neuropathy (diabetes, alcoholism...)
- Cauda equina syndrome or progressive neurologic deficit in the lower extremity
- Neurogenic bladder/bowel syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep paravertebral periforaminal ozone injecitonDeep paravertebral periforaminal ozone injection was administered to the patients in the ozone injection group 4 times under ultrasound guidance, 10 ug/ml 5ml twice a week in the first week and 15 ug/ml 5ml twice a week in the second week. Patients will be evaluated according to the study criteria at the beginning, at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up. | Procedure or surgery | deep paravertebral- periforaminal ozone injection |
| transforaminal steroid injecitonTransforaminal epidural steroid injection group, steroid (dexamethasone 8mg/2ml 2ml) injection was performed under the guidance of fluoroscopy. Patients will be evaluated according to the study criteria at the beginning, at 15 days, 1 month, and 2 months. Physical examination findings were evaluated before starting the treatment and at the 2nd month follow-up. | Procedure or surgery | transforaminal steroid injeciton |
Primary outcome
PAİN-Visual Analog Scala (VAS)
Time frame: 2nd week, 4th week, 8th week pain change
Visual Analog Scala (VAS), patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Severity of pain was assessed VAS using the standard 10 cm (back pain and leg pain) with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end.
Quality of life - Short Form-36 (SF-36)
Time frame: 2nd week, 4th week, 8th week quality of life change
Satisfaction assessed by the SF-36. Short Form (SF-36) was used to investigate the quality of life of the patients.The reliability and validity of the Turkish version of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores show better Quality of life.
Oswestry Disability Index (ODI)
Time frame: 2nd week, 4th week, 8th week pain change
In the ODI questionnaire, the effect of low back pain on activities of daily living is questioned. In the test, which consists of 10 questions in total, the patient's pain intensity, the effects of pain on personal care, walking, lifting weights, standing, sitting, sleeping, sexual life, social life and traveling are questioned. The patient can get a minimum of 0 and a maximum of 5 points from each question. The maximum score to be taken from the test is 50. The patient's score is found by dividing the total score of the patient by 50, which is the maximum score, and calculating the percentage. (Patient's score ÷ maximum score × 100). Accordingly, it is calculated how much the patient's life activities are affected.
Physical examination-Lumbar joint range of motion examination
Time frame: 2nd week, 4th week, 8th week examination change
Lumbar joint range of motion examination( flexion-extansion-lateral flexion-rotation)
Physical examination-straight leg raise test
Time frame: 2nd week, 4th week, 8th week examination change
straight leg raise test- It is recorded whether there is normal or abnormal
Physical examination-femoral nerve stretch test
Time frame: 2nd week, 4th week, 8th week examination change
femoral nerve stretch test - It is recorded whether there is normal or abnormal
Physical examination-Walleix palpation
Time frame: 2nd week, 4th week, 8th week examination change
Walleix palpation- It is recorded whether there is tenderness in Walleix palpation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep paravertebral periforaminal ozone injeciton and transforaminal steroid injeciton in people with Low Back Pain, Posterior Compartment, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact esra ülgen kıratlıoğlu (+905079614194, esraulgen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAİN-Visual Analog Scala (VAS) (time frame: 2nd week, 4th week, 8th week pain change). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.