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Completed

NCT Number: NCT07773428

Effectiveness of Ozone Therapy Versus Pulsed Radiofrequency in Low Back Pain With Radiculopathy

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.

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Key information

Conditions

Low Back Pain Back Pain Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nizwa Hospital

Nizwa, AL Radah State, 611, Oman

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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.

Exclusion criteria

  • • Severe canal or foraminal stenosis.
  • Severely dehydrated disc.
  • Allergy to antibiotics or contrast media.
  • Previous spine surgery.

Treatment and study plan

Intradiscal ozone therapy

Procedure

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 radiofrequency

Procedure

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.

Primary outcomes

  1. pain intensity

    Time frame: 6 months

    measured with the Visual Analog Scale at baseline and at 1,3, and 6 months

  2. functional disability

    Time frame: 6 months

    measured with the Oswestry Disability Index at baseline and at 1,3, and 6 months

Secondary outcomes

  1. Procedure-related complications

    Time frame: 6 months

    discomfort during the injection, Transient back and leg pain

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Collaborators

  • Nizwa Hospital, Sultanate of Oman

Registry information

Official study title

Comparative Effectiveness of Ozone Therapy Versus Pulsed Radiofrequency in Low Back Pain With Radiculopathy: a Retrospective Comparative Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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