Low Back PainNCT07773428
Effectiveness of Ozone Therapy Versus Pulsed Radiofrequency in Low Back Pain With Radiculopathy
A study testing Intradiscal ozone therapy and Pulsed radiofrequency in people with Low Back Pain and Radiculopathy, run by Zagazig University at 1 site in Oman.
Trial summary
Treatment selection for refractory radicular low back pain is frequently made in the absence of direct comparative evidence between competing minimally invasive options. By placing ozone therapy and PRF side by side within a single clinical service and following patients for six months, this study contributes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Radiculopathy
- What is being tested?
- Intradiscal ozone therapy and Pulsed radiofrequency
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteOman
- Study dates
- 1 Jul 2026to 1 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age greater than 18 years.
- Low back and leg pain of more than six weeks' duration.
- Failure to respond to conservative management.
- Grade I-IV disc pathology.
- Unilateral leg pain.
- Three or fewer spinal levels are involved.
Who cannot join
- • Severe canal or foraminal stenosis.
- Severely dehydrated disc.
- Allergy to antibiotics or contrast media.
- Previous spine surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of Ozone Therapy Versus Pulsed Radiofrequency in Low Back Pain With Radiculopathy: a Retrospective Comparative Study
Treatment selection for refractory radicular low back pain is frequently made in the absence of direct comparative evidence between competing minimally invasive options. By placing ozone therapy and PRF side by side within a single clinical service and following patients for six months, this study contributes pragmatic evidence that maps more closely onto everyday decision-making than isolated single-arm reports.
The findings carry practical implications for clinicians, patients, and health systems. For clinicians, a clearer understanding of which modality offers more sustained pain relief can inform first-line selection and patient counseling. For patients, improved durability of benefit translates directly into better quality of life, reduced reliance on systemic analgesics, and a lower likelihood of progressing to surgery. For resource-constrained health systems, evidence favoring a lower-cost, well-tolerated, outpatient procedure has clear value for service planning and cost-effectiveness.
Finally, by reporting outcomes transparently-including instances where between-group differences did not survive statistical adjustment-this study aims to add measured, reliable evidence to a literature that has at times been limited by small samples, heterogeneous protocols, and short follow-up.
Read the detailed description
A retrospective comparative study was conducted at a single centre (Nizwa Hospital, Sultanate of Oman) including patients who received interventions between January 2025 and December 2025; data collection took place from 1 July 2026 to 30 July 2026 following approval by the Research and Ethical Review and Approval Committee (RERAC), Ministry of Health, Sultanate of Oman (reference DGHS/R\&S/PROPOSAL_APPROVED/MoH/CSR/26/32322). A total of 69 patients were included, of whom 34 received ozone therapy and 35 underwent PRF treatment. Baseline demographic variables (age, body mass index, and gender distribution) were analyzed to confirm group comparability. Pain intensity and functional disability were assessed using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI) at baseline, 1 month, 3 months, and 6 months.
- Conditions
- Low Back Pain, Radiculopathy
- Being tested
- Intradiscal ozone therapy, Pulsed radiofrequency
- Medical subject headings
- Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradiscal ozone therapyProcedure or surgery
Antibiotic prophylaxis was administered with cefazolin 1 g intravenously over 15 minutes, approximately one hour before the procedure. Under fluoroscopic guidance, a 22-gauge, 15-cm Chiba needle was advanced into the target intervertebral disc, and intradiscal placement was confirmed by contrast injection, demonstrating satisfactory spread. Ozone 5 mL at a concentration of 30 µg/mL was injected intradiscally. The needle was then repositioned to the inferior neural foramen (Kambin's triangle); contrast injection confirmed appropriate spread without vascular uptake, and a further 5 mL of ozone at 30 µg/mL was administered into the foraminal/perineural region.
Pulsed radiofrequencyProcedure or surgery
Under fluoroscopic guidance, a radiofrequency needle was advanced to the target safe (supraneural) triangle adjacent to the affected dorsal root ganglion. Correct placement was confirmed in anteroposterior and lateral views, and contrast injection demonstrated appropriate epidural/perineural spread without vascular uptake. Pulsed radiofrequency was applied at 42 °C for 6 minutes, with impedance maintained between 300 and 500 Ω. Following PRF, 3 mL of a mixture containing 40 mg methylprednisolone with lidocaine was injected into the foraminal region.
| Study group | Role | What they receive |
|---|---|---|
| Intradiscal ozone therapy | Active comparator | Not described Receives: Procedure: Intradiscal ozone therapy |
| Pulsed radiofrequency | Active comparator | Not described Receives: Procedure: Pulsed radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
measured with the Visual Analog Scale at baseline and at 1,3, and 6 months
Measured: 6 months
functional disability
measured with the Oswestry Disability Index at baseline and at 1,3, and 6 months
Measured: 6 months
Secondary outcomes (1)
Procedure-related complications
discomfort during the injection, Transient back and leg pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Jul 2026
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Collaborators
- Nizwa Hospital, Sultanate of Oman
- Responsible party
- Principal investigator, Sherif M. S. Mowafy, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773428
- Sponsor's protocol ID
- APPROVED/MoH/CSR/26/32322
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the current study are available from the principal investigator upon reasonable request.
Publications
Strand NH, Hagedorn JM, Dunn T, Johnson B, Abd-Elsayed A, Covington S, Freeman J, Dawodu A, Maloney J. Advances in radiofrequency ablation: mechanism of action and technology. Ann Palliat Med. 2024 Jul;13(4):1028-1034. doi: 10.21037/apm-23-457. Epub 2024 Jul 18.
PubMed 39043563Sam J, Catapano M, Sahni S, Ma F, Abd-Elsayed A, Visnjevac O. Pulsed Radiofrequency in Interventional Pain Management: Cellular and Molecular Mechanisms of Action - An Update and Review. Pain Physician. 2021 Dec;24(8):525-532.
PubMed 34793641
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Ozone Therapy Versus Pulsed Radiofrequency in Low Back Pain With Radiculopathy: a Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT07773428
- Acronym / sponsor ID
- APPROVED/MoH/CSR/26/32322
- Conditions
- Low Back Pain, Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Collaborators
- Nizwa Hospital, Sultanate of Oman
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 19 Aug 2026 (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.
Treatment selection for refractory radicular low back pain is frequently made in the absence of direct comparative evidence between competing minimally invasive options. By placing ozone therapy and PRF side by side within a single clinical service and following patients for six months, this study contributes pragmatic evidence that maps more closely onto everyday decision-making than isolated single-arm reports.
The findings carry practical implications for clinicians, patients, and health systems. For clinicians, a clearer understanding of which modality offers more sustained pain relief can inform first-line selection and patient counseling. For patients, improved durability of benefit translates directly into better quality of life, reduced reliance on systemic analgesics, and a lower likelihood of progressing to surgery. For resource-constrained health systems, evidence favoring a lower-cost, well-tolerated, outpatient procedure has clear value for service planning and cost-effectiveness.
Finally, by reporting outcomes transparently-including instances where between-group differences did not survive statistical adjustment-this study aims to add measured, reliable evidence to a literature that has at times been limited by small samples, heterogeneous protocols, and short follow-up.
Detailed description
A retrospective comparative study was conducted at a single centre (Nizwa Hospital, Sultanate of Oman) including patients who received interventions between January 2025 and December 2025; data collection took place from 1 July 2026 to 30 July 2026 following approval by the Research and Ethical Review and Approval Committee (RERAC), Ministry of Health, Sultanate of Oman (reference DGHS/R\&S/PROPOSAL_APPROVED/MoH/CSR/26/32322). A total of 69 patients were included, of whom 34 received ozone therapy and 35 underwent PRF treatment. Baseline demographic variables (age, body mass index, and gender distribution) were analyzed to confirm group comparability. Pain intensity and functional disability were assessed using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI) at baseline, 1 month, 3 months, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradiscal ozone therapy | Active comparator | Procedure: Intradiscal ozone therapy |
| Pulsed radiofrequency | Active comparator | Procedure: Pulsed radiofrequency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Age greater than 18 years.
Key exclusion criteria (4 listed)
- • Severe canal or foraminal stenosis.
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 |
|---|---|---|
| Intradiscal ozone therapyAntibiotic prophylaxis was administered with cefazolin 1 g intravenously over 15 minutes, approximately one hour before the procedure. Under fluoroscopic guidance, a 22-gauge, 15-cm Chiba needle was advanced into the target intervertebral disc, and intradiscal placement was confirmed by contrast injection, demonstrating satisfactory spread. Ozone 5 mL at a concentration of 30 µg/mL was injected intradiscally. The needle was then repositioned to the inferior neural foramen (Kambin's triangle); contrast injection confirmed appropriate spread without vascular uptake, and a further 5 mL of ozone at 30 µg/mL was administered into the foraminal/perineural region. | Procedure or surgery | Intradiscal ozone therapy |
| Pulsed radiofrequencyUnder fluoroscopic guidance, a radiofrequency needle was advanced to the target safe (supraneural) triangle adjacent to the affected dorsal root ganglion. Correct placement was confirmed in anteroposterior and lateral views, and contrast injection demonstrated appropriate epidural/perineural spread without vascular uptake. Pulsed radiofrequency was applied at 42 °C for 6 minutes, with impedance maintained between 300 and 500 Ω. Following PRF, 3 mL of a mixture containing 40 mg methylprednisolone with lidocaine was injected into the foraminal region. | Procedure or surgery | Pulsed radiofrequency |
Primary outcome
pain intensity
Time frame: 6 months
measured with the Visual Analog Scale at baseline and at 1,3, and 6 months
functional disability
Time frame: 6 months
measured with the Oswestry Disability Index at baseline and at 1,3, and 6 months
1 secondary outcome
Procedure-related complications
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 39043563Strand NH, Hagedorn JM, Dunn T, Johnson B, Abd-Elsayed A, Covington S, Freeman J, Dawodu A, Maloney J. Advances in radiofrequency ablation: mechanism of action and technology. Ann Palliat Med. 2024 Jul;13(4):1028-1034. doi: 10.21037/apm-23-457. Epub 2024 Jul 18.
- Background: PubMed 34793641Sam J, Catapano M, Sahni S, Ma F, Abd-Elsayed A, Visnjevac O. Pulsed Radiofrequency in Interventional Pain Management: Cellular and Molecular Mechanisms of Action - An Update and Review. Pain Physician. 2021 Dec;24(8):525-532.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current study are available from the principal investigator upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradiscal ozone therapy and Pulsed radiofrequency in people with Low Back Pain and Radiculopathy, run by Zagazig University at 1 site in Oman.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 19 Aug 2026. 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 Oman. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07773428, which also lists 2 linked publications.
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 Aug 2026.