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临床试验/NCT03066960
NCT03066960招募中不适用

Long-term Efficacy of Radiofrequency Neurotomy for Chronic Zygapophysial (Facet) Joint Related Neck Pain

Oslo University Hospital4 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
34
试验地点
4
主要终点
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment

研究概览

简要总结

This is a single-center, double blind, sham-controlled randomized trial (N: 34) to assess the long term efficacy of RF neurotomy of cervical medial branches. Patients with chronic unilateral neck pain who are found eligible and achieve ≥50% pain relief of two predictive and comparative test blocks will be included in the trial in a primary analysis. We will further test whether a strict selection of ≥80% pain relief better predicts efficacious RF neurotomy compared with a less strict selection of ≥50% to <80%. After 6 months sham-treated patients may also be offered active unblinded RF treatment. Demographic and clinical data will be recorded at baseline while primary and secondary outcome measurements are recollected after 1, 3, 6, 9 and 12 months. Primary outcome measurements include self-reported neck function (NDI) and pain relief after 6 months.

详细描述

Chronic neck pain represents a common health problem. The mechanisms appear to be multifactorial. Researchers have suggested a disturbed interplay between the deep neck muscles and facet joints. In Europe and the US radiofrequency neurotomy has become a common treatment. The evidence base, however, is still insufficient. Thus, a double blind, sham-controlled, randomized, single-center trial is carried out. Based on current data and a single center study design, 34 randomized participants, completing the trial, have shown adequate to obtain sufficient statistical power. To simplify the data collection a digital internet based program is used. Patients with chronic unilateral neck pain, referred to Oslo University Hospital or responding to public announcements, and not responding to non-interventional treatment will be screened. Those who are found eligible and achieve ≥50% pain relief after predictive and comparative test blocks, will be included in the study. We will further test whether a strict selection of ≥80% pain relief better predicts efficacious RF neurotomy compared with a less strict selection of ≥50% to <80%. After 6 months participants who received sham and still suffer from neck pain, will be offered unblinded RF neurotomy and additional 12 month unblinded follow up if the results support this treatment. Demographic and clinical data will be recorded at baseline. The primary and secondary outcome measurements are recollected after 1, 3, 6, 9 and 12 months. Primary outcome measurements include self-reported neck function (NDI) and pain relief after 6 months. Regression analyses will be used to identify how pain relief of two test blocks and pain catastrophizing predict response to RF neurotomy. If RF neurotomy is found superior to sham treatment, this may be implemented in the national treatment program for selected patients with chronic neck pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Min 18 years and Maximum 80 years
  • Read and understand Norwegian
  • Stable neck pain >12 months, with or without unilateral headache
  • Average of worst pain intensity last three days ≥ 4 out of maximum 10
  • Neck Disability Index >15 points or > 30 percentage points.
  • At least two predictive blocks ≥ 50% pain relief 30 to 60 minutes after lidocaine and 30 to 180 minutes after bupivacaine .

排除标准

  • Serious cervical pathology (acute cervical disc herniation, radiculopathy, myelopathy, spinal anomalies and chronic widespread pain
  • Opioid consumption > 50 morphine equivalents/day
  • Ongoing litigation process and applying for disability insurance/benefits
  • Serious psychiatric disorder (DSM-IV-TR) diagnosed at a psychiatric unit, including suicidal thoughts and somatization (from Hopkins Symptom Check List 25 ≥ 2.5)
  • Ongoing addictive behavior ( diagnostic criteria in Statistical Manual, 4th Edition)
  • Unstable medical condition (ASA 4, serious vascular disease like unstable angina)
  • Bacterial infection
  • Malignancy
  • Chronic generalized pain
  • Hypersensitive to contrast agents or local anesthetics
  • Pregnancy
  • Bleeding diathesis
  • Previously radiofrequency neurotomy

结局指标

主要结局

Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment

时间窗: 6 months

Two independent group comparison of change in pain intensity (triplicate values from three consecutive days on a numeric pain scale 0-10 which provides a continuous variable)

Change in neck function after RF neurotomy vs sham treatment

时间窗: 6 months

Two independent group comparison of change of Neck Disability Index scores -continuous variable 0-50)

次要结局

  • Change in health related quality of life after RF neurotomy vs sham treatment(12 months)
  • How moderately positive response to test block influences neck function after RF treatment(6 months)
  • How highly positive response to test block influences 50% pain relief after RF treatment(6 months)
  • How catastrophizing influences pain relief after RF treatment.(6 months)
  • Change in mental distress after RF neurotomy vs sham treatment.(12 months)
  • Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment(12 months)
  • Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment(12 months)
  • How moderately positive response to test block influences 30% pain relief after RF treatment(6 months)
  • How moderately positive response to test block influences 50% pain relief after RF treatment(6 months)
  • How catastrophizing influences neck function after RF treatment.(6 months)
  • Change in neck function after RF neurotomy vs sham treatment(12 months)
  • Change in drug consumption after RF neurotomy vs sham treatment(12 months)
  • How highly positive response to test block influences neck function after RF treatment(6 months)
  • How highly positive response to test block influences 30% pain relief after RF treatment(6 months)
  • Change in number of neck/pain treatments after RF neurotomy vs sham treatment(6 months)
  • Change in sleep disturbances after RF neurotomy vs sham treatment.(12 months)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gunnvald Kvarstein

Professor

Oslo University Hospital

研究点 (4)

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