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

NCT05043961 | Terminated

• 1 other identifier: 2022-2704
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Sacroiliac; Backache; Chronic Pain

Keywords

radiofrequency ablation; Sacroiliac joint pain; chronic pain

Outcome Measures

Primary Outcomes (1)

• Success rate

  proportion of patients reporting \>50% pain relief

  6 months

Secondary Outcomes (16)

• Succes rate

  3 months

• Succes rate

  1 month

• Succes rate

  10 month

• Change in Pain score

  1 month

• Change in Pain score

  3 month

Other Outcomes (4)

• analgesia from sacral lateral branch block

  baseline

• Success rate

  3 months

• Success rate

  6 months

Study Arms (1)

study group

Patients who report \>50% pain relief after an intra articular sacroiliac joint injection but lasting less than 3 months who are scheduled to receive a SIJ RFA at the Maisonneuve-Rosemont Hospital's Chronic Pain Clinic and who meet inclusion criteria will be offered to participate in this study. Intervention: Sacroiliac joint rafiofrequency ablation using the bipolar palissade approach and 3-tined needles

Procedure: Palisade sacroiliac joint radiofrequency ablation using 3-tined needles

Interventions

Palisade sacroiliac joint radiofrequency ablation using 3-tined needles PROCEDURE

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.

study group

Eligibility Criteria

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

Study Population

Patients who are candidates for sacroiliac joint radio frequency ablation at the Maisonneuve-Rosemont Hospital's Chronic Pain Clinic

You may qualify if:

• years and older
• Low back pain caused by SIJ dysfunction lasting \> 6 months:
• Predominantly axial pain below the L5 vertebrae with an average daily Verbal Numercial Scale Score (VNS) \>4;
• \>50% pain relief after a fluoroscopically guided intraarticular injection of local anesthetic and steroids in the SIJ but lasting less than 3 months. Injection performed in the last 6 months prior to enrollment.

You may not qualify if:

• Pregnancy
• Spinal pathology that may impede recovery such as severe spondylolisthesis at L5/S1, severe scoliosis, or lumbar fusion;
• Active radicular pain;
• Worker's compensation;
• Cognitive limitation or linguistic barrier making pain assessment through questionnaire impossible;
• Implanted pacemaker or defibrillator;
• Refusal.

Sponsors & Collaborators

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

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T2M4, Canada

Location

MeSH Terms

Conditions

Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 14, 2021
• Study Start: June 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: February 11, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

CA (1)