Clinical trial NCT03066960: Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain
Official title: Long-term Efficacy of Radiofrequency Neurotomy for Chronic Zygapophysial (Facet) Joint Related Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Keywords: radiofrequency neurotomy
zygapophyseal joint
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2017-03-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in neck function after RF neurotomy vs sham treatment
timeFrame: 6 months
measure: Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
timeFrame: 6 months
Secondary outcomes:
measure: Change in neck function after RF neurotomy vs sham treatment
timeFrame: 12 months
measure: Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
timeFrame: 1 month
measure: Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
timeFrame: 3 months
measure: Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
timeFrame: 9 months
measure: Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment
timeFrame: 12 months
measure: Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
timeFrame: 1 month
measure: Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
timeFrame: 3 months
measure: Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
timeFrame: 6 months
measure: Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
timeFrame: 9 months
measure: Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment
timeFrame: 12 months
measure: Change in health related quality of life after RF neurotomy vs sham treatment
timeFrame: 6 months
measure: Change in health related quality of life after RF neurotomy vs sham treatment
timeFrame: 12 months
measure: Change in drug consumption after RF neurotomy vs sham treatment
timeFrame: 6 months
measure: Change in drug consumption after RF neurotomy vs sham treatment
timeFrame: 12 months
measure: Change in number of neck/pain treatments after RF neurotomy vs sham treatment
timeFrame: 6 months
measure: How highly positive response to test block influences neck function after RF treatment
timeFrame: 6 months
measure: How moderately positive response to test block influences neck function after RF treatment
timeFrame: 6 months
measure: How highly positive response to test block influences 30% pain relief after RF treatment
timeFrame: 6 months
measure: How moderately positive response to test block influences 30% pain relief after RF treatment
timeFrame: 6 months
measure: How highly positive response to test block influences 50% pain relief after RF treatment
timeFrame: 6 months
measure: How moderately positive response to test block influences 50% pain relief after RF treatment
timeFrame: 6 months
measure: How catastrophizing influences neck function after RF treatment.
timeFrame: 6 months
measure: How catastrophizing influences pain relief after RF treatment.
timeFrame: 6 months
measure: Change in mental distress after RF neurotomy vs sham treatment.
timeFrame: 6 months
measure: Change in mental distress after RF neurotomy vs sham treatment.
timeFrame: 12 months
measure: Change in sleep disturbances after RF neurotomy vs sham treatment.
timeFrame: 6 months
measure: Change in sleep disturbances after RF neurotomy vs sham treatment.
timeFrame: 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department for Pain and Complex Disorders
state: Torgarden
city: Oslo
country: Norway
facility: Department of Pain Management and Research Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Gunnvald Kvarstein, Dr. Med
role: PRINCIPAL_INVESTIGATOR
References: