Clinical trial NCT05818774: End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves
Official title: A Prospective, Randomized, Double Blind Clinical Trial Comparing End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves: the EndPaRL Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Zygapophyseal Joint Arthritis
Keywords: Radiofrequency neurotomy
Cervical Medial Branch Nerves
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the EndPaRL study is to compare the efficacy and effectiveness of the two techniques utilizing sharp straight conventional radiofrequency needle with a trident needle for radiofrequency neurotomy of Cervical Medial Branch Nerves (CMBNs), in patients presenting with chronic, moderate-to-severe, neck pain due to cervical zygapophyseal joint osteoarthritis, as diagnosed by positive responses to two consecutive diagnostic blocks with local anesthetic of the CMBN.


Eligibility criteria: Inclusion Criteria:

1. Adult patient of either gender aged 18-85 years
2. Predominant axial (non-radicular) neck pain for at least 3 months
3. 7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation
4. Moderate or greater functional impairment due to pain, defined as NDI Questionnaire raw score of 15 out of 50 (≥30% )e Failure to respond to conservative medical management (pharmacologic, physical therapy) for at least 3 months;

f) Positive response to two consecutive diagnostic blocks of the CMBN with a short and long-acting anesthetic

Exclusion Criteria:

1. Participants with financial incentives or litigation associated with ongoing pain
2. Inability to complete assessment instruments
3. Chronic widespread pain
4. Prior RFN of the CMBN;
5. Severe mental health issues
6. Pregnancy or other reason that precludes the use of fluoroscopy
7. Untreated coagulopathy
8. Systemic or local infection at the time of screening.

Primary outcomes:
measure: Difference in mean Numerical Rating Scale (NRS) for pain scores
timeFrame: 3 months
measure: Proportion of patients with positive analgesic response
timeFrame: 3 months
Secondary outcomes:
measure: Difference in the mean Numerical Rating Scale (NRS) for pain scores
timeFrame: at 1, 6 and 12 months
measure: Proportion of patients with positive analgesic response
timeFrame: at 1,3, 6 and 12 months
measure: Proportion of patients with reduction in the Neck Disability Index (NDI) score
timeFrame: at 1, 3, 6, and 12 months
measure: Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale
timeFrame: at 1, 3, 6, and 12 months
measure: Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality
timeFrame: at 1, 3, 6, and 12 months
measure: Difference in mean European Quality of Life (EQ-5D-5L score), a self-assessed, health related, quality of life questionnaire. It ranges from 5 to 25, where higher scores indicate worse outcome.
timeFrame: at 1, 3, 6, and 12 months
measure: Differences in duration of procedure between 2 groups
timeFrame: day of procedure
measure: Differences in discomfort procedure between 2 groups
timeFrame: day of procedure
measure: Differences in radiation dose of procedure between 2 groups
timeFrame: day of procedure
measure: Differences in cost of procedure between 2 groups
timeFrame: day of procedure
measure: Difference in opioid requirements in daily oral morphine equivalents between the groups
timeFrame: at 3, 6, and 12 months follow-ups after the procedure
measure: Difference in average physical activity and sleep duration
timeFrame: 1 week before the procedure and 1 month after the procedure
measure: Difference in incidence of peri-procedural complications and post-procedural adverse effects following the RFN procedure
timeFrame: at 1, 3, 6, and 12 months after the procedures
measure: Patient assumption of the group assigned
timeFrame: at 3 months after procedure
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network (UHN)
state: Ontario
city: Barcelona
country: Spain
facility: Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, Hospital Clínic de Barcelona, University of Barcelona.
state: Catalonia
Study officials:
affiliation: Department of Anesthesia and Pain Management, University Health Network, Toronto
name: Anuj Bhatia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lord SM, Barnsley L, Wallis BJ, McDonald GJ, Bogduk N. Percutaneous radio-frequency neurotomy for chronic cervical zygapophyseal-joint pain. N Engl J Med. 1996 Dec 5;335(23):1721-6. doi: 10.1056/NEJM199612053352302.
citation: Barnsley L. Percutaneous radiofrequency neurotomy for chronic neck pain: outcomes in a series of consecutive patients. Pain Med. 2005 Jul-Aug;6(4):282-6. doi: 10.1111/j.1526-4637.2005.00047.x.
citation: MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012 May;13(5):647-54. doi: 10.1111/j.1526-4637.2012.01351.x. Epub 2012 Mar 28.