Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain

• ClinicalTrials.gov Identifier: NCT03066960
• Recruitment Status: Recruiting
• First Posted: March 1, 2017
• Last Update Posted: May 23, 2019
• Sponsor: Oslo University Hospital
• Collaborator: St. Olavs Hospital
• Information provided by (Responsible Party): Gunnvald Kvarstein, Oslo University Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Neck Pain	Procedure: Radiofrequency neurotomy; Procedure: Sham treatment	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Long-term Efficacy of Radiofrequency Neurotomy for Chronic Zygapophysial (Facet) Joint Related Neck Pain
• Actual Study Start Date: October 8, 2018
• Estimated Primary Completion Date: December 14, 2022
• Estimated Study Completion Date: December 14, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Radiofrequency neurotomy group; Unilateral radiofrequency neurotomy of medial branches to the dorsal ramus at one or two cervical levels	Procedure: Radiofrequency neurotomy; RF neurotomy represents a nerve destructive, coagulating technique affecting the conduction through all nerve fibers.
Sham Comparator: Sham group; Unilateral sham treatment of medial branches to the dorsal ramus at one or two cervical levels	Procedure: Sham treatment; Sham treatment represents no coagulation of the nerve and will not affect the nerve conduction.

Outcome Measures

Primary Outcome Measures :

1. Change in neck function after RF neurotomy vs sham treatment [ Time Frame: 6 months ]
   Two independent group comparison of change of Neck Disability Index triplicate scores -continuous variable 0-100 - from three consecutive days)
2. Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment [ Time Frame: 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)

Secondary Outcome Measures :

1. Change in neck function after RF neurotomy vs sham treatment [ Time Frame: 12 months ]
   Two independent group comparison of change of Neck Disability Index triplicate scores -continuous variable 0-100 - from three consecutive days)
2. Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment [ Time Frame: 1 month ]
   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)
3. Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment [ Time Frame: 3 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)
4. Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment [ Time Frame: 9 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)
5. Change in pain intensity (numeric pain scale) after RF neurotomy vs sham treatment [ Time Frame: 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)
6. Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment [ Time Frame: 1 month ]
   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)
7. Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment [ Time Frame: 3 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)
8. Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment [ Time Frame: 6 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)
9. Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment [ Time Frame: 9 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)
10. Change in pain intensity (categorical pain scale) after RF neurotomy vs sham treatment [ Time Frame: 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)
11. Change in health related quality of life after RF neurotomy vs sham treatment [ Time Frame: 6 months ]
    Two independent group comparison of change of EuroQuol-5-Dimensions Index scores (continuous variable from -0.59 to 1.00)
12. Change in health related quality of life after RF neurotomy vs sham treatment [ Time Frame: 12 months ]
    Two independent group comparison of change of EuroQuol-5-Dimensions Index scores (continuous variable from -0.59 to 1.00)
13. Change in drug consumption after RF neurotomy vs sham treatment [ Time Frame: 6 months ]
    Two independent group comparison of change of the numbers of analgesic drugs (continuous variable)
14. Change in drug consumption after RF neurotomy vs sham treatment [ Time Frame: 12 months ]
    Two independent group comparison of change of the numbers of analgesic drugs (continuous variable)
15. Change in number of neck/pain treatments after RF neurotomy vs sham treatment [ Time Frame: 6 months ]
    Two independent group comparison of change of the numbers of neck/pain treatments (continuous variable)
16. How highly positive response to test block influences neck function after RF treatment [ Time Frame: 6 months ]
    Regression analysis on how ≥80% pain relief (independent categorical variable) predicts >15% reduction of Neck disability Score (categorical variable) after RF neurotomy
17. How moderately positive response to test block influences neck function after RF treatment [ Time Frame: 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
18. How highly positive response to test block influences 30% pain relief after RF treatment [ Time Frame: 6 months ]
    Regression analysis on how ≥80% pain relief (independent categorical variable) predicts >30% reduction in pain intensity (categorical variable) after RF neurotomy
19. How moderately positive response to test block influences 30% pain relief after RF treatment [ Time Frame: 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
20. How highly positive response to test block influences 50% pain relief after RF treatment [ Time Frame: 6 months ]
    Regression analysis on how ≥80% pain relief (independent categorical variable) predicts >50% reduction in pain intensity (categorical variable) after RF neurotomy
21. How moderately positive response to test block influences 50% pain relief after RF treatment [ Time Frame: 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
22. How catastrophizing influences neck function after RF treatment. [ Time Frame: 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
23. How catastrophizing influences pain relief after RF treatment. [ Time Frame: 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
24. Change in mental distress after RF neurotomy vs sham treatment. [ Time Frame: 6 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)
25. Change in mental distress after RF neurotomy vs sham treatment. [ Time Frame: 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)
26. Change in sleep disturbances after RF neurotomy vs sham treatment. [ Time Frame: 6 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.
27. Change in sleep disturbances after RF neurotomy vs sham treatment. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Gunnvald Kvarstein, Dr. Med; +47 92295309; gunnvald.kvarstein@uit.no

Contact: Bård Lundeland, PhD; +47 41238959; 'Bård Lundeland' <baalun@ous-hf.no>

Locations

Norway

Department for Pain and Complex Disorders; Recruiting

Trondheim, Torgarden, Norway, 3250

Contact: Petter Borchgrevink, PhD +4772822500 petter.borchgrevink@ntnu.no

Department of Pain Management and Research Oslo University Hospital; Recruiting

Oslo, Norway, 4950

Contact: Gunnvald Kvarstein, PhD +47923026161 gunnvald.kvarstein@uit.no

Contact: Bård Lundeland, PhD 4+4723026161 bard.lundeland@ous-hf.no

Sponsors and Collaborators

Oslo University Hospital

St. Olavs Hospital

Investigators

• Principal Investigator: Gunnvald Kvarstein, Dr. Med; Oslo University Hospital

More Information

• Responsible Party: Gunnvald Kvarstein, Professor, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT03066960 History of Changes
• Other Study ID Numbers: 2015/2194
• First Posted: March 1, 2017
• Last Update Posted: May 23, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: From 9 months to 5 years after publication
• Access Criteria: To get access the researchers need to provide a methodologically sound proposal in accordance with the institutional guidelines and sign a data access agreement.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gunnvald Kvarstein, Oslo University Hospital:

radiofrequency neurotomy; zygapophyseal joint

Additional relevant MeSH terms:

Neck Pain; Pain; Neurologic Manifestations; Signs and Symptoms