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临床试验/NCT05043961
NCT05043961终止不适用

Determination of the Success Rate of the Palisade Lateral Branch Technique Using Multi-tined Needles for Sacro-iliac Joint Radiofrequency Ablation

Ciusss de L'Est de l'Île de Montréal1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
12
试验地点
1
主要终点
Success rate

研究概览

简要总结

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.

详细描述

Single center, prospective cohort study. all patients presenting to the Maisonneuve-Rosemont's Pain center with chronic low back pain of SIJ origin who are candidates for SIJ RFA during a two year period will be invited to participate in this study. SIJ RFA will be performed using the palisade technique using 3-tined needles. The patients will be followed for a period of 10 months to determine pain relief, opioid use, satisfaction and impact on disability.

Study design: Prospective, cohort study Population: Patients who are scheduled to receive a SIJ RFA at the Maisonneuve-Rosemont Hospital's Chronic Pain Clinic Duration of study: 2 years Patient included in the study will be followed up for 10 months. Sample size: Approximately 30 patients (anticipated)

General Study procedure This study's methodology will follow the standard practice for treating patients with SIJ pain at the Maisonneuve-rosemont Hospital First, an intraarticular SIJ injection of local anesthetic with a corticosteroid is offered to patients presenting with pain of presumed SIJ origin (predominantly axial low back pain, below the L5 vertebrae, positive SIJ provocation maneuvers). Patients who experience significant pain relief but lasting less than 3 months are offered a SLBB. According to standard practice, all patients receiving a SLBB file a pain diary that evaluates the pain intensity over a 36h period following the block (see Annex 1). This diary is sent back by e-mail to the treating physician and will be deemed positive if >50% pain relief is reported for at least 2h but lasting less than 24h. Patients with a positive SLBB are always considered for SIJ RFA. Patients with a negative SLBB may or may not undergo SIJ RFA, depending on the treating physician. Indeed, although SLBB have been suggested as a more appropriate method for selecting patients who should undergo SIJ RFA, its predictive value has not been formally evaluated and many physicians feel that not performing SIJ RFA in patients with negative SLBB may lead to withholding an effective treatment from patients. Thus, the standard practice is to proceed with SIJ RFA even with a negative SLBB because its prognostic value is not clear.

For the purpose of this study, all patients experiencing >50% pain relief after an intra articular SIJ injection of local anesthetic and corticosteroid but lasting less than 3 months and who wish to undergo SIJ RFA, as suggested by their treating physician, will be considered for inclusion in the study. Then, following general procedure, all patients will undergo a SLBB performed according to the previously described technique. The data from all the diaries will be collected to determine the rate of positive SLBBs among patients who had significant but not sustained pain relief from intraarticular SIJ injection. Then, all patients will proceed to SIJ RFA.

Recrutement:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 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.

排除标准

  • 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;

结局指标

主要结局

Success rate

时间窗: 6 months

proportion of patients reporting \>50% pain relief

次要结局

  • Succes rate(10 month)
  • Impact on disability(10 months)
  • Chang in Pain score(10 month)
  • Impact on improvement(10 months)
  • Change in Pain score(6 month)
  • Opioid use(10 months)

研究者

发起方
Ciusss de L'Est de l'Île de Montréal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Veronique Brulotte

Principal Investigator

Maisonneuve-Rosemont Hospital

研究点 (1)

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