Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain

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

The researchers are planning a two-center double blind, sham-controlled randomized trial (N: 44) 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 ≥80% pain relief of two predictive and comparative test blocks, will be included in the primary analysis. Those 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 sham-treated patients may also be offered active 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.

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.

Unilateral radiofrequency neurotomy of medial branches to the dorsal ramus at one or two cervical levels

RF neurotomy represents a nerve destructive, coagulating technique affecting the conduction through all nerve fibers.

Two independent group comparison of change of Neck Disability Index triplicate scores -continuous variable 0-100 - from three consecutive days)

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)

Two independent group comparison of change of Neck Disability Index triplicate scores -continuous variable 0-100 - from three consecutive days)

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)

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)

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)

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)

Two independent group comparison of change in pain intensity (categorical 6-point pain scale wth the alternatives worse, unchanged, <50% reduced, ≥50% reduced, and pain free which provides a categorial variable)

Two independent group comparison of change in pain intensity (categorical 6-point pain scale wth the alternatives worse, unchanged, <50% reduced, ≥50% reduced, and pain free which provides a categorial variable)

Two independent group comparison of change in pain intensity (categorical 6-point pain scale wth the alternatives worse, unchanged, <50% reduced, ≥50% reduced, and pain free which provides a categorial variable)

Two independent group comparison of change in pain intensity (categorical 6-point pain scale wth the alternatives worse, unchanged, <50% reduced, ≥50% reduced, and pain free which provides a categorial variable)

Two independent group comparison of change in pain intensity (categorical 6-point pain scale wth the alternatives worse, unchanged, <50% reduced, ≥50% reduced, and pain free which provides a categorial variable)

Two independent group comparison of change of EuroQuol-5-Dimensions Index scores (continuous variable from -0.59 to 1.00)

Two independent group comparison of change of EuroQuol-5-Dimensions Index scores (continuous variable from -0.59 to 1.00)

Two independent group comparison of change of the numbers of neck/pain treatments (continuous variable)

Regression analysis on how ≥80% pain relief (independent categorical variable) predicts >15% reduction of Neck disability Score (categorical variable) after RF neurotomy

Regression analysis on how ≥50% and <80% pain relief (independent categorical variable) predicts >15% reduction of Neck disability Score (categorical variable) after RF neurotomy

Regression analysis on how ≥80% pain relief (independent categorical variable) predicts >30% reduction in pain intensity (categorical variable) after RF neurotomy

Regression analysis on how ≥50% and <80% pain relief (independent categorical variable) predicts >30% reduction in pain intensity (categorical variable) after RF neurotomy

Regression analysis on how ≥80% pain relief (independent categorical variable) predicts >50% reduction in pain intensity (categorical variable) after RF neurotomy

Regression analysis on how ≥50 and <80% pain relief (independent categorical variable) predicts >50% reduction in pain intensity (categorical variable) after RF neurotomy

Regression analysis on how Pain Catastrophizing Scale score ≥30 (independent categorical variable) predict ≥ 15% reduction of Neck Disability Score (categorical variable) after RF neurotomy vs Pain Catastrophizing Scale score < 30

Regression analysis on how Pain Catastrophizing Scale scores ≥30 (independent categorical variable) predict >30% reduction in pain intensity (categorical variable) after RF neurotomy vs Pain Catastrophizing Scale scores < 30

Two independent group comparison of change in Hopkin Symptom Check List (HSCL 25) sumscore which is a continuous variable on anxiety and depressive symptoms, ranging from 1 (normal) to 4 (worse)

Two independent group comparison of change in Hopkin Symptom Check List (HSCL 25) sumscore which is a continuous variable on anxiety and depressive symptoms, ranging from 1 (normal) to 4 (worse)

Two independent group comparison of change in sleep. Sleep Subscale in Neck Disability Index part 7. A continuous variable based on a 6 point scale ranging from 0 to 6 where 0 is no problem and 6 i severe insomnia.

Two independent group comparison of change in sleep. Sleep Subscale in Neck Disability Index part 7. A continuous variable based on a 6 point scale ranging from 0 to 6 where 0 is no problem and 6 i severe insomnia.

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

Individual Participant Data Sharing Plan. In accordance with the general data sharing policy at OUH, the deidentified, individual data can be made available for external researchers from 9 months to 5 years after publication. However, to get access the researchers need to provide a methodologically sound proposal in accordance with the institutional guidelines and sign a data access agreement.

To get access the researchers need to provide a methodologically sound proposal in accordance with the institutional guidelines and sign a data access agreement.