Neck Pain Clinical Trial
— EndPaRLOfficial 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
NCT number | NCT05818774 |
Other study ID # | 22-5634 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 10, 2023 |
Est. completion date | March 2025 |
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | March 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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% 5. Cervical spine imaging compatible with Pathria's grade 3 or grade 4 zygapophyseal joint osteoarthritis 6. Failure to respond to conservative medical management (pharmacologic, physical therapy) for at least 3 months; 7. 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network (UHN) | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 3 months | |
Primary | 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) | 3 months | |
Secondary | Difference in the mean Numerical Rating Scale (NRS) for pain scores | Difference in mean NRS for pain scores at 6 and 12 months after the RFA procedure. Scale from 0 to 10, where higher scores mean worse outcome | at 6 and 12 months | |
Secondary | 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 6 & 12 months | at 6 and 12 months | |
Secondary | Proportion of patients with reduction in the Neck Disability Index (NDI) score | Proportion of patients with =10% reduction in the NDI score at 3, 6, and 12 months. Scale from 0 to 50, where higher scores mean worse outcome | at 3, 6, and 12 months | |
Secondary | 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 3, 6, and 12 months | at 3, 6, and 12 months | |
Secondary | Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for sleep quality | Difference in mean PSQI scores scores at 3, 6, and 12 months. It has a range of 0-21; higher scores indicate worse sleep quality. | at 3, 6, and 12 months | |
Secondary | 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 | at 3, 6, and 12 months | |
Secondary | Differences in duration of procedure between 2 groups | Differences in duration of procedure in two groups | day of procedure | |
Secondary | Differences in discomfort procedure between 2 groups | Differences in patient discomfort of procedure | day of procedure | |
Secondary | Differences in radiation dose of procedure between 2 groups | Differences in radiation dose of procedure | day of procedure | |
Secondary | Differences in cost of procedure between 2 groups | Differences in cost of the procedures | day of procedure | |
Secondary | 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 | at 3, 6, and 12 months follow-ups after the procedure |
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