Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain

NCT ID: NCT03066960

Last Updated: 2023-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2025-12-14

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.

Conditions

Neck Pain

Keywords

radiofrequency neurotomy; zygapophyseal joint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Radiofrequency neurotomy group

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

Group Type: ACTIVE_COMPARATOR

Radiofrequency neurotomy

Intervention Type: PROCEDURE

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

Sham group

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

Group Type: SHAM_COMPARATOR

Sham treatment

Intervention Type: PROCEDURE

Sham treatment represents no coagulation of the nerve and will not affect the nerve conduction.

Interventions

Radiofrequency neurotomy

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

Intervention Type: PROCEDURE

Sham treatment

Sham treatment represents no coagulation of the nerve and will not affect the nerve conduction.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gunnvald Kvarstein

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gunnvald Kvarstein, Dr. Med

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Department for Pain and Complex Disorders

Trondheim, Torgarden, Norway

Site Status: RECRUITING

Department of Pain Management and Research Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Gunnvald Kvarstein, Dr. Med

Role: CONTACT

Phone: +47 92295309

Email: gunnvald.kvarstein@uit.no

Bård Lundeland, PhD

Role: CONTACT

Phone: +47 41238959

Email: 'Bård Lundeland' <baalun@ous-hf.no>

Facility Contacts

Petter Borchgrevink, PhD

Role: primary

Gunnvald Kvarstein, PhD

Role: primary

Bård Lundeland, PhD

Role: backup

Other Identifiers

2015/2194

Identifier Type: -

Identifier Source: org_study_id