Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain
Unknown statusNot applicableNCT03066960
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Long-term Efficacy of Radiofrequency Neurotomy for Chronic Zygapophysial (Facet) Joint Related Neck Pain
- Conditions
- Interventions
- Procedure: Radiofrequency neurotomy
- Procedure: Sham treatment
- Sponsor
- Oslo University Hospital
- Collaborators
- St. Olavs Hospital
- Start date
- 2019-01-01
- Primary completion
- 2024-12-14
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Norway
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria * 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 . Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03066960