End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves

University Health Network, Toronto72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Neck Pain Zygapophyseal Joint Arthritis

Interventions

Intervention type: RF nerve lesioning at 80-85 degree Celsius for 90 seconds Intervention name: Straight sharp conventional (SIS's technique) Intervention description: Technique as described in the SIS Practice Guidelines for parallel lesioning cannulae placement

Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulaePROCEDURE

Intervention type: RF nerve lesioning lesioning at 80-850 Celsius for 90 seconds Intervention name: End-on placement of the multitined trident cannulae Intervention description: Patient in lateral position, targeting joint position between the inferior C2 and superior C3 facets, the middle of the facet pillars for the third to fifth cervical levels, and the superior part of the sixth and seventh cervical facets.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (3)

Women's College Hospital

Toronto, Ontario, Canada

RECRUITING

University Health Network (UHN)

Toronto, Ontario, Canada

RECRUITING

Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, Hospital Clínic de Barcelona, University of Barcelona.

Barcelona, Catalonia, Spain

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Difference in mean Numerical Rating Scale (NRS) for pain scores

Difference in the mean pain scores before and after procedure. Scale from 0 to 10, where higher scores mean worse outcome

Time frame: 3 months

Proportion of patients with positive analgesic response

Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline)

Time frame: 3 months

Secondary Outcomes

Difference in the mean Numerical Rating Scale (NRS) for pain scores

Difference in mean NRS for pain scores at 1, 6 and 12 months after the RFA procedure. Scale from 0 to 10, where higher scores mean worse outcome

Time frame: at 1, 6 and 12 months

Proportion of patients with positive analgesic response

Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline) at 1,3, 6 \& 12 months

Time frame: at 1,3, 6 and 12 months

Proportion of patients with reduction in the Neck Disability Index (NDI) score

Proportion of patients with ≥10% reduction in the NDI score at 1, 3, 6, and 12 months. Scale from 0 to 50, where higher scores mean worse outcome

Time frame: at 1, 3, 6, and 12 months

Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale

PGIC score is a 7 point scale depicting a patient's subjective rating of overall improvement over time, as proportion of participants reporting improvement in the PGIC scale at 1, 3, 6, and 12 months

Time frame: at 1, 3, 6, and 12 months

Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality

Difference in mean PSQI scores scores at 1, 3, 6, and 12 months. It has a range of 0-21; higher scores indicate worse sleep quality.

Time frame: at 1, 3, 6, and 12 months

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.

Difference in mean EQ-5D-5L scores at 3, 6, and 12 months

Time frame: at 1, 3, 6, and 12 months

Differences in duration of procedure between 2 groups

Differences in duration of procedure in two groups

Time frame: day of procedure

Differences in discomfort procedure between 2 groups

Differences in patient discomfort of procedure

Time frame: day of procedure

Differences in radiation dose of procedure between 2 groups

Differences in radiation dose of procedure

Time frame: day of procedure

Differences in cost of procedure between 2 groups

Differences in cost of the procedures

Time frame: day of procedure

Difference in opioid requirements in daily oral morphine equivalents between the groups

Difference in opioid requirements in daily oral morphine equivalents in mg averaged over the 1 week before and at 3, 6, and 12 months follow-ups after the procedure

Time frame: at 3, 6, and 12 months follow-ups after the procedure

Difference in average physical activity and sleep duration

Difference in average physical activity and sleep duration as measured by wrist-worn actigraphy worn for 1 week before the procedure and 1 month after the procedure

Time frame: 1 week before the procedure and 1 month after the procedure

Difference in incidence of peri-procedural complications and post-procedural adverse effects following the RFN procedure

Difference in incidence of peri-procedural complications and post-procedural adverse effects following the RFN procedure in the two groups during and at 1, 3, 6, and 12 months after the procedures

Time frame: at 1, 3, 6, and 12 months after the procedures

Patient assumption of the group assigned

Patient assumption of the group assigned at 3 months after the RFN procedure

Time frame: at 3 months after procedure

End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts