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

NCT07773428 | Completed DMC

• 1 other identifier: APPROVED/MoH/CSR/26/32322
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• pain intensity

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

  6 months

• functional disability

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

  6 months

Secondary Outcomes (1)

• Procedure-related complications

  6 months

Study Arms (2)

Intradiscal ozone therapy

ACTIVE COMPARATOR

Procedure: Intradiscal ozone therapy

Pulsed radiofrequency

ACTIVE COMPARATOR

Procedure: Pulsed radiofrequency

Interventions

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.

Intradiscal ozone therapy

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.

Pulsed radiofrequency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead
• Nizwa Hospital, Sultanate of Oman: collaborator

Study Sites (1)

Nizwa Hospital

Nizwa, AL Radah State, 611, Oman

Location

Related Publications (2)

• 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.

  PMID: 39043563 BACKGROUND

• Sam 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.

  PMID: 34793641 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Radiculopathy

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: July 1, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after study publication
• Access Criteria: by email

Locations

OM (1)