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Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain

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

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.

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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

Resource links provided by the National Library of Medicine


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.




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.



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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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Gunnvald Kvarstein, Dr. Med +47 92295309 gunnvald.kvarstein@uit.no
Contact: Bård Lundeland, PhD +47 41238959 'Bård Lundeland' <baalun@ous-hf.no>

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

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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    Key Record Dates
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.

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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:
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Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms