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

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 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.

Conditions

• Low Back Pain
• Radiculopathy

Interventions

PROCEDURE

Intradiscal ozone therapy

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.

PROCEDURE

Pulsed radiofrequency

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.

Sponsors & Collaborators

• Nizwa Hospital, Sultanate of Oman

  collaborator UNKNOWN

• Zagazig University

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2026-08-01

Completion

2026-08-01

Countries

• Oman

Study Locations