Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain

University of Oslo (UIO)

Status: Enrolling

Conditions: Neck Pain

Treatments: Procedure: Radiofrequency neurotomy; Procedure: Sham treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03066960

2015/2194

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups

Radiofrequency neurotomy group

Active Comparator group

Description:

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

Treatment:

Procedure: Radiofrequency neurotomy

Sham group

Sham Comparator group

Description:

Unilateral sham treatment of medial branches to the dorsal ramus at one or two cervical levels

Treatment:

Procedure: Sham treatment