Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain (NCT03066960) | Clinical Trial Compass
UnknownNot Applicable
Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain
Norway34 participantsStarted 2019-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in neck function after RF neurotomy vs sham treatment
Timeframe: 6 months
2
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment