Neck PainEndPaRLNCT05818774
End-on Versus Parallel Radiofrequency Lesioning for Neurotomy of the Cervical Medial Branch Nerves
A study testing Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning and Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae in people with Neck Pain and Zygapophyseal Joint Arthritis, run by University Health Network, Toronto at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neck Pain, Zygapophyseal Joint Arthritis
- What is being tested?
- Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning and Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Mar 2023to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient of either gender aged 18-85 years
- Predominant axial (non-radicular) neck pain for at least 3 months
- 7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation
- 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;
- Positive response to two consecutive diagnostic blocks of the CMBN with a short and long-acting anesthetic
Who cannot join
- Participants with financial incentives or litigation associated with ongoing pain
- Inability to complete assessment instruments
- Chronic widespread pain
- Prior RFN of the CMBN;
- Severe mental health issues
- Pregnancy or other reason that precludes the use of fluoroscopy
- Untreated coagulopathy
- Systemic or local infection at the time of screening.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Canada2 sites, 2 recruiting
- Recruiting
Women's College Hospital
Toronto, Ontario, M5S 1B3
Anuj Bhatia, +1(416)603-5800 ext. 2308, Anuj.Bhatia@uhn.ca
Didem Bozak, +1 (416)-323-6008, didem.bozak@wchospital.ca
- Recruiting
University Health Network (UHN)
Toronto, Ontario, M5T 2S8
Danielle Alvares, PhD, 416-603-5800 ext. 3517, danielle.alvares@uhn.ca
Spain1 site, 1 recruiting
- Not yet recruiting
Division of Pain Medicine, Department of Anesthesiology, Reanimation, and Pain Medicine, Hospital Clínic de Barcelona, University of Barcelona.
Barcelona, Catalonia, 08036
Guilherme Ferreira Dos Santos, MD, (+34) 657-757-477, guilhermesantos@campus.ul.pt
About this study
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
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.
- Conditions
- Neck Pain, Zygapophyseal Joint Arthritis
- Being tested
- Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning, Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae
- Keywords
- Radiofrequency neurotomy, Cervical Medial Branch Nerves
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioningProcedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| RFN of CMBNn with end-on lesioning with multitIned trident cannulae | Experimental | Intervention type: RF nerve end-on 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 Receives: Procedure: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae |
| RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique) | Active comparator | Intervention type: RF nerve parallel lesioning at 80-850 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 Receives: Procedure: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 3 months
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: at 1, 3, 6, and 12 months
Differences in duration of procedure between 2 groups
Differences in duration of procedure in two groups
Measured: day of procedure
Differences in discomfort procedure between 2 groups
Differences in patient discomfort of procedure
Measured: day of procedure
Differences in radiation dose of procedure between 2 groups
Differences in radiation dose of procedure
Measured: day of procedure
Differences in cost of procedure between 2 groups
Differences in cost of the procedures
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 3 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start10 Mar 2023
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anuj Bhatia, University Health Network, Toronto
- Investigators
- Anuj Bhatia, MD, PhD, Principal investigator, Department of Anesthesia and Pain Management, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818774
- Sponsor's protocol ID
- 22-5634
- Acronym
- EndPaRL
- Status last verified
- Jan 2026
- First submitted
- 5 Apr 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the IPD at the moment
Publications
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.
PubMed 22458772Lord 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.
PubMed 8929263Barnsley 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.
PubMed 16083457Alomari A, Ferreira-Dos-Santos G, Singh M, Burnham T, Cao X, McCormick Z, Flamer D, Kumar P, Hoydonckx Y, Khan JS, Tumber PS, Alvares D, Bhatia A. End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the "EndPaRL" study. Trials. 2023 Nov 11;24(1):721. doi: 10.1186/s13063-023-07752-9.
PubMed 37951900
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05818774
- Acronym / sponsor ID
- EndPaRL / 22-5634
- Conditions
- Neck Pain, Zygapophyseal Joint Arthritis
- Keywords
- Radiofrequency neurotomy, Cervical Medial Branch Nerves
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFN of CMBNn with end-on lesioning with multitIned trident cannulae | Experimental | Procedure: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulaeIntervention type: RF nerve end-on 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 |
| RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique) | Active comparator | Procedure: Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioningIntervention type: RF nerve parallel lesioning at 80-850 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient of either gender aged 18-85 years
- Predominant axial (non-radicular) neck pain for at least 3 months
- 7-day average NRS score for neck pain ≥ 5/10 at baseline evaluation
- 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;
- Positive response to two consecutive diagnostic blocks of the CMBN with a short and long-acting anesthetic
Key exclusion criteria (8 listed)
- Participants with financial incentives or litigation associated with ongoing pain
- Inability to complete assessment instruments
- Chronic widespread pain
- Prior RFN of the CMBN;
- Severe mental health issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioningIntervention 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 | Procedure or surgery | RFN of CMBNn with parallel lesioning with sharp straight conventional cannulae (SIS's technique) |
| Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulaeIntervention 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. | Procedure or surgery | RFN of CMBNn with end-on lesioning with multitIned trident cannulae |
Primary outcome
Difference in mean Numerical Rating Scale (NRS) for pain scores
Time frame: 3 months
Difference in the mean pain scores before and after procedure. Scale from 0 to 10, where higher scores mean worse outcome
Proportion of patients with positive analgesic response
Time frame: 3 months
Proportion of patients with positive analgesic response (≥50% reduction in the NRS score for neck pain compared to baseline)
14 secondary outcomes
Difference in the mean Numerical Rating Scale (NRS) for pain scores
Time frame: at 1, 6 and 12 months
Proportion of patients with positive analgesic response
Time frame: at 1,3, 6 and 12 months
Proportion of patients with reduction in the Neck Disability Index (NDI) score
Time frame: at 1, 3, 6, and 12 months
Proportion of participants reporting improvement in the Patient Global Impression of Change (PGIC) scale
Time frame: at 1, 3, 6, and 12 months
Difference in mean Pittsburgh Sleep Quality Index (PSQI) scores for 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.
Time frame: at 1, 3, 6, and 12 months
Differences in duration of procedure between 2 groups
Time frame: day of procedure
Differences in discomfort procedure between 2 groups
Time frame: day of procedure
Differences in radiation dose of procedure between 2 groups
Time frame: day of procedure
Differences in cost of procedure between 2 groups
Time frame: day of procedure
Difference in opioid requirements in daily oral morphine equivalents between the groups
Time frame: at 3, 6, and 12 months follow-ups after the procedure
Difference in average physical activity and sleep duration
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
Time frame: at 1, 3, 6, and 12 months after the procedures
Patient assumption of the group assigned
Time frame: at 3 months after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 22458772MacVicar 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.
- Results publication: PubMed 8929263Lord 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.
- Results publication: PubMed 16083457Barnsley 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.
- Derived from this study: PubMed 37951900Alomari A, Ferreira-Dos-Santos G, Singh M, Burnham T, Cao X, McCormick Z, Flamer D, Kumar P, Hoydonckx Y, Khan JS, Tumber PS, Alvares D, Bhatia A. End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the "EndPaRL" study. Trials. 2023 Nov 11;24(1):721. doi: 10.1186/s13063-023-07752-9.
- Individual participant dataSharing planned: No. There is no plan to share the IPD at the moment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anuj Bhatia, MD, PhD principal investigator
Department of Anesthesia and Pain Management, University Health Network, Toronto
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with parallel lesioning and Radiofrequency neurotomy (RFN) of Cervical Medial Branch Nerves (CMBNn) with end-on lesioning with multitined trident cannulae in people with Neck Pain and Zygapophyseal Joint Arthritis, run by University Health Network, Toronto at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Alvares, PhD ((416) 603-5800 ext. 3517, danielle.alvares@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean Numerical Rating Scale (NRS) for pain scores (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05818774, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.