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Radiofrequency Ablation

study group for Chronic Pain (TriPal Trial)

N/A
Recruiting
Research Sponsored by Ciusss de L'Est de l'Île de Montréal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 month
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Chronic Pain
  • Sacroiliac Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Chang in Pain score
Change in Pain score
Impact on disability
+3 more
Other study objectives
Success rate
analgesia from sacral lateral branch block

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: study groupExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Ciusss de L'Est de l'Île de MontréalLead Sponsor
77 Previous Clinical Trials
6,313 Total Patients Enrolled
1 Trials studying Chronic Pain
60 Patients Enrolled for Chronic Pain
~1 spots leftby Dec 2024