Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain

Not Applicable

Recruiting

• Conditions: Neck Pain
• Interventions: Procedure: Sham treatment; Procedure: Radiofrequency neurotomy

• Registration Number: NCT03066960
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed Description

Chronic neck pain represents a common health problem. The mechanisms appear to be multifactorial. Researchers have suggested a disturbed interplay between the deep neck muscles and facet joints. In Europe and the US radiofrequency neurotomy has become a common treatment. The evidence base, however, is still insufficient. Thus, a double blind, sham-controlled, randomized, single-center trial is carried out. Based on current data and a single center study design, 34 randomized participants, completing the trial, have shown adequate to obtain sufficient statistical power. To simplify the data collection a digital internet based program is used. Patients with chronic unilateral neck pain, referred to Oslo University Hospital or responding to public announcements, and not responding to non-interventional treatment will be screened. Those who are found eligible and achieve ≥50% pain relief after predictive and comparative test blocks, will be included in the study. 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 participants who received sham and still suffer from neck pain, will be offered unblinded RF neurotomy 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 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 pain relief of two test blocks and pain catastrophizing 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.

Study Timeline

• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-02-23
• Study First Posted: 2017-03-01
• Study Start: 2019-01-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-11
• Primary Completion: 2024-12-14
• Study Completion: 2025-12-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group	Sham treatment	Unilateral sham treatment of medial branches to the dorsal ramus at one or two cervical levels
Radiofrequency neurotomy group	Radiofrequency neurotomy	Unilateral radiofrequency neurotomy of medial branches to the dorsal ramus at one or two cervical levels

Primary Outcome Measures

Name	Time	Method
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment	6 months	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)
Change in neck function after RF neurotomy vs sham treatment	6 months	Two independent group comparison of change of Neck Disability Index scores -continuous variable 0-50)

Secondary Outcome Measures

Name	Time	Method
Change in health related quality of life after RF neurotomy vs sham treatment	12 months	Two independent group comparison of change of EuroQuol-5-Dimensions Index scores (continuous variable from -0.59 to 1.00)
How moderately positive response to test block influences neck function after RF treatment	6 months	Regression analysis on how ≥50% and \<80% pain relief (independent categorical variable) predicts \>15% reduction of Neck disability Score (categorical variable) after RF neurotomy
How highly positive response to test block influences 50% pain relief after RF treatment	6 months	Regression analysis on how ≥80% pain relief (independent categorical variable) predicts \>50% reduction in pain intensity (categorical variable) after RF neurotomy
How catastrophizing influences pain relief after RF treatment.	6 months	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
Change in mental distress after RF neurotomy vs sham treatment.	12 months	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)
Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment	12 months	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)
Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment	12 months	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)
How moderately positive response to test block influences 30% pain relief after RF treatment	6 months	Regression analysis on how ≥50% and \<80% pain relief (independent categorical variable) predicts \>30% reduction in pain intensity (categorical variable) after RF neurotomy
How moderately positive response to test block influences 50% pain relief after RF treatment	6 months	Regression analysis on how ≥50 and \<80% pain relief (independent categorical variable) predicts \>50% reduction in pain intensity (categorical variable) after RF neurotomy
How catastrophizing influences neck function after RF treatment.	6 months	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
Change in neck function after RF neurotomy vs sham treatment	12 months	Two independent group comparison of change of Neck Disability Index scores -continuous variable 0-50
Change in drug consumption after RF neurotomy vs sham treatment	12 months	Two independent group comparison of change of the numbers of analgesic drugs (continuous variable)
How highly positive response to test block influences neck function after RF treatment	6 months	Regression analysis on how ≥80% pain relief (independent categorical variable) predicts \>15% reduction of Neck disability Score (categorical variable) after RF neurotomy
How highly positive response to test block influences 30% pain relief after RF treatment	6 months	Regression analysis on how ≥80% pain relief (independent categorical variable) predicts \>30% reduction in pain intensity (categorical variable) after RF neurotomy
Change in number of neck/pain treatments after RF neurotomy vs sham treatment	6 months	Two independent group comparison of change of the numbers of neck/pain treatments (continuous variable)
Change in sleep disturbances after RF neurotomy vs sham treatment.	12 months	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.

Trial Locations

Locations (2)

Department for Pain and Complex Disorders; 🇳🇴 Trondheim, Torgarden, Norway

Department of Pain Management and Research Oslo University Hospital; 🇳🇴 Oslo, Norway