Treatment for chronic neck pain using radiofrequency neurotomy
Long-term Efficacy of Radiofrequency Neurotomy for Chronic Zygapophysial (Facet) Joint Related Neck Pain
This study is testing if a treatment called radiofrequency neurotomy can help people with chronic neck pain feel better and improve their neck function after other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 2 sites (Trondheim, Torgarden and 1 other locations) |
| Trial ID | NCT03066960 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the long-term effectiveness of radiofrequency neurotomy on patients suffering from chronic unilateral neck pain. It is a single-center, double-blind, sham-controlled randomized trial involving 34 participants who have not responded to non-interventional treatments. Eligible patients will undergo predictive test blocks to determine their pain relief, and those achieving at least 50% relief will be included in the study. The trial aims to compare outcomes based on different thresholds of pain relief to better predict the efficacy of the treatment. Follow-up assessments will be conducted at multiple intervals over a year to measure pain relief and neck function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with chronic unilateral neck pain lasting over 12 months and who have not found relief from other treatments.
Not a fit: Patients with serious cervical pathologies, high opioid consumption, or unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and quality of life for patients with chronic neck pain.
How similar studies have performed: Previous studies have shown promise for radiofrequency neurotomy in treating chronic pain, but this specific approach is still being evaluated for its efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Trondheim, Torgarden and 1 other locations
- Department for Pain and Complex Disorders — Trondheim, Torgarden, Norway (Recruiting)
- Department of Pain Management and Research Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Gunnvald Kvarstein, Dr. Med — Oslo University Hospital
- Study coordinator: Gunnvald Kvarstein, Dr. Med
- Email: gunnvald.kvarstein@uit.no
- Phone: +47 92295309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.