Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neck Pain
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
Chronic neck pain represents a common health problem. The mechanisms appear to be multifactorial. Researchers have suggested a disturbed interplay between the neck muscles and the facet joints. In Europe and the US radiofrequency neurotomy (RFN) has become a common treatment. The evidence base, howe...
Chronic neck pain represents a common health problem. The mechanisms appear to be multifactorial. Researchers have suggested a disturbed interplay between the neck muscles and the facet joints. In Europe and the US radiofrequency neurotomy (RFN) has become a common treatment. The evidence base, however, is still insufficient. Thus, a double blind, sham-controlled, randomized, two-center trial will be carried out including 44 participants. To simplify the data collection a digital internet based program will be used. Patients with chronic unilateral neck pain, referred to Oslo University Hospital or St Olavs University Hospital and not responding to non-interventional treatment, will be screened. Those who are found eligible and achieve ?80% pain relief after predictive and comparative test blocks, will be included in the primary analysis. Patients with ?50% and < 80% pain relief will be included in a secondary analysis to examine whether a strict selection better predicts the effect of RF neurotomy. After 6 months participants who received sham and still suffers from neck pain, will be offered unblinded RF ablation 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 (including blinding test) 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 ?80% vs. ?50 and <80% pain relief of two test blocks and pain catastrophizing (Pain Catastrophizing Scale = PCS) 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.
Tracking Information
- NCT #
- NCT03066960
- Collaborators
- St. Olavs Hospital
- Investigators
- Principal Investigator: Gunnvald Kvarstein, Dr. Med Oslo University Hospital