Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain
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ClinicalTrials.gov Identifier: NCT03066960 |
Recruitment Status : Unknown
Verified December 2020 by Gunnvald Kvarstein, Oslo University Hospital.
Recruitment status was: Recruiting
First Posted : March 1, 2017
Last Update Posted : January 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neck Pain | Procedure: Radiofrequency neurotomy Procedure: Sham treatment | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Radiofrequency neurotomy group
Unilateral radiofrequency neurotomy of medial branches to the dorsal ramus at one or two cervical levels
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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
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Procedure: Sham treatment
Sham treatment represents no coagulation of the nerve and will not affect the nerve conduction. |
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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)
- 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)
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066960
Contact: Gunnvald Kvarstein, Dr. Med | +47 92295309 | gunnvald.kvarstein@uit.no | |
Contact: Bård Lundeland, PhD | +47 41238959 | 'Bård Lundeland' <baalun@ous-hf.no> |
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 |
Principal Investigator: | Gunnvald Kvarstein, Dr. Med | Oslo University Hospital |
Responsible Party: | Gunnvald Kvarstein, Professor, Oslo University Hospital |
ClinicalTrials.gov Identifier: | NCT03066960 |
Other Study ID Numbers: |
2015/2194 |
First Posted: | March 1, 2017 Key Record Dates |
Last Update Posted: | January 5, 2021 |
Last Verified: | December 2020 |
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 |
radiofrequency neurotomy zygapophyseal joint |
Neck Pain Pain Neurologic Manifestations |