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Palisade Lateral Branch Technique Using Multi-tined Needles for Sacro-iliac Joint Radiofrequency Ablation

NCT05043961 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2025-02-13

No results posted yet for this study

Summary

The sacro-iliac joint is a large joint that can be the source of chronic pain. Many treatment options have been proposed to treat SIJ pain, with variable efficacy. The next step in managing those patients who can't get sustained pain relief from conservative treatment is radiofrequency ablation (RFA) of the SIJ's posterior innervation.

However, the success rate of SIJ RFA, as determined by the proportion of patients reporting greater than 50% pain relief 6 months after the intervention, varies substantially across studies, ranging from 38-71 %. This may be explained partly by the fact that there may be incomplete lesioning of the target nerves supplying the joint. To overcome these particularities, two RFA techniques have emerged: cooled RFA and bipolar RFA.

Cooled radiofrequency is the one that has been studied the most, and good evidence supports its efficacy. However, its superiority to conventional RF for the treatment of SIJ pain is not confirmed.

Alternatively, a bipolar RFA technique using conventional radiofrequency needles and equipment can be used. The efficacy of this relatively newer technique has been demonstrated by only one study, and although the results were promising, it is not known whether they could be replicated. The success of the palisade technique could be enhanced by using multi-tined expandable electrodes, such as the 3-tined Trident cannulas, with only small increases in cost.

In clinical practice, the palisade technique using 3-tines needles is routinely used. However, its efficacy has not been formally evaluated. The primary objective of this prospective cohort study will be to determine the success rate of the palisade SIJ RFA (P-RF) technique using the 3-tined needles, determined as the proportion of patients reporting \>50% pain relief, 6 months after the procedure.

Conditions

Interventions

PROCEDURE

Palisade sacroiliac joint radiofrequency ablation using 3-tined needles

Palisade-RF is performed using a conventional temperature-controlled RF generator generating monopolar and bipolar lesions at 85°C for 150 sec, with a 60 sec ramp time. Four, 18 Gauge 3-tined, 90 mm cannulas with an active tip of 10 mm (RF Trident; Diros Technology) will be used along with a four-output radiofrequency generator configured for quadripolar and bipolar output. The RF energy is delivered, making one quadripolar or two bipolar lesions at a time. This procedure is repeated at the remaining target sites by leapfroging the needles, until the entire length is lesioned. Lesioning the L5 dorsal ramus: o The RF needle is inserted at the inflexion between the ala of the sacrum and the S1 superior articular process. The RF energy is delivered, creating a monopolar lesion.

Sponsors & Collaborators

  • Ciusss de L'Est de l'Île de Montréal

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-12-01
Completion
2025-02-11

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05043961 on ClinicalTrials.gov