A Prospective Study to Evaluate the Efficacy of Iovera Lumbar Medial Branch Cryoneurolysis Versus Radiofrequency Ablation for the Treatment of Chronic Low Back Pain

Conditions

• Low Back Pain, Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Iovera Medial Branch Cryoneurolysis — DEVICE
  The iovera group will receive fluoroscopic guided medial branch cryoneurolysis with the subject in the prone position under asepsis: * Investigator injects 1% lidocaine at the treatment site using a 25-gauge, 3/4 -inch needle to numb the skin and tissue around the facet joint * Introducer needle is inserted through the skin wheal to the target medial branch nerve below the junction of the superior articular and transverse process * The introducer needle is positioned, and an x-ray image is taken to confirm the needle's position * With the desired introducer needle position confirmed, the iovera Smart Tip is guided through the introducer needle and the handpiece is secured to the Smart Tip. The start/stop button on the iovera° handpiece is then pressed to start the cycle. * After the cycle is complete, Smart Tip can be removed and next treatment cycle can commence ensuring an overlap of the ice ball * The needle is removed, and light compression is applied with gauze
• Radiofrequency ablation (RFA) — PROCEDURE
  Subjects will receive a fluoroscopic guided RFA medial branch block in the prone position under asepsis: * The Right L4, L5, S1 articular pillars are identified with fluoroscopy at each level and the target points are located * A skin wheal is formed using 5mL 1% Lidocaine and 5mL 0.25% Bupivacaine * A 20-gauge, 10cm needle with a 10mm active tip is inserted using a 15-degree oblique view and a 15-degree caudad angle onto the waist of each pillar at each level * Anterior-posterior and oblique neuroforamen views confirm positioning * Stimulation is performed and recorded to confirm proper needle placement * A mixture of 3mL of 0.25% Bupivacaine and 2mL of 1% Lidocaine is divided and injected at each level * A lesion is then performed at each level at 80 degrees centigrade for 60 seconds * The needles are removed, and bandages applied to the puncture sites * The same procedure is carried out on the opposite side

Study Details

A research study is being conducted to compare two treatments for long-term low back pain: * One uses the iovera° system, which applies cold to certain nerves in the lower back. * The other is the standard treatment called radiofrequency ablation, which uses heat. The primary objective is to find out which treatment works better to reduce back pain. Participants in this study will be randomly placed in one of the two treatment groups. The clinical research team will check on participant pain levels and overall health before and after the procedure for about 12 months. The entire study will last about 14 months for each participant.

Key Dates

Start date

Apr 30, 2026

Status verified

Apr 2026

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

110 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: iovera cryoneurolysis
  Subjects will receive iovera cryoneurolysis to the medial branch nerves of the lumbar spine.
• Active Comparator: Radiofrequency ablation (RFA)
  Subjects will receive radiofrequency ablation (RFA) to the medial branch nerves of the lumbar spine.

Primary Outcome Measure

Numeric rating scale (NRS) pain intensity score [ Time Frame: 360 days after intervention ]

Central Contacts

• Karina Gritsenko, MD
  609-369-0344
  [email protected]
• Rafi Khandaker, BA
  9297152343
  [email protected]

Locations (1)

Find similar trials in The Bronx, NY