Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain

June 22, 2022 updated by: Allevio Pain Management Clinic

Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain: a Single-blind Randomized Controlled Clinical Trial

Different studies have revealed different success rates and patient satisfaction after cervical facet C-RF. In a study on 32 patients, with 15 months follow up, 25% had complete pain relief (8). Another study had shown mean pain relief of 12.5 months and 11.5 months following a repeat procedure, with an effectiveness of 95% in 47 patients (8). In one study a success rate of 88% after first RF, and 86% following a repeat RF in 49 patients with facet mediated cervicogenic headache. They regarded the absence of anesthesia in the distribution of the 3rd occipital nerve, a technical failure (9). In a study from New Zealand, demonstrated cervical facet RF as the sole treatment modality, produced 61% -74% complete pain relief with a median duration of 15-17 months in patients who had responded to facet joints diagnostic block (10).

One more study in 2012 has demonstrated high voltage P-RF had a higher short-term effect compare to usual voltage, but results are still lower than C-RF (11). A double blind randomized prospective study has illustrated P-RF did not show any success rate in 6 months pain control, whereas C-RF had 95% pain control for trigeminal neuralgia (12).

Cohen in a recent study has compared P-RF with steroid injection for occipital neuralgia or migraine with occipital nerve tenderness (13). Six weeks pain relief was 61% in P-RF group, and 36% in steroid injection group, with a positive outcome of 34%, and 26% respectively (13). One study on 2010 had reached to 52.6%, 6 months pain improvement on occipital neuralgia (14).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients fulfilling eligibility criteria will be randomly allocated to PRF or CRF in a 1:1 ratio. The statistician will use RedCap software to generate random numbers. Patients will be registered to Redcap software and will be concealed from both patients and health care staff. The study coordinator will enter patients' consent and study eligibility information to the Redcap. Once eligible, the Redcap will assign the patient to one of the study group. Patients will be blinded in the proposed study. The assessor is the person who will assess treatment success at the end of the study based on data from completed questionnaires. Questionnaires will be completed every three months by patients through RedCap System. A therapist is the person who will perform the procedure (pain specialist physician). The therapist will not be blinded, because of the nature of intervention.

Patient recruitment is estimated to be completed within 15-24 months. If the required sample size (calculated below) is recruited prior to this time, patient recruitment will be curtailed.

During the first visit the investigator will perform eligibility for neck RF and patient will be received information about the study.

Patients will be book for two MBB 4-6 weeks apart. If the patient was eligible after the second MBB, Patient will be asked to sign Informed consent before screening. Screening and recruitment, and randomization, and administer questionnaires will be performed by research co-ordinator. Study informed consent form (ICF) can be signed on the RF procedure day. If additional visits will be required to finalize the procedures related to the first visit they will be scheduled accordingly. After randomization the qualified participants will be scheduled for their RF.

For the female subjects between the age of 18-50 a pregnancy test will be asked to obtain on screening visit in order to reduce the risk of pregnancy and potential harm to fetus, unless you had previous tubal ligation, or hysterectomy. Post menopause patients are excluded.

Participants will be asked to complete the follow-up questionnaires at 1, 3, 6, 9, and 12 months.

LANSS questionnaire will be asked to be completed 6 weeks after RF. If the score was 12 or higher, patient will be asked to complete them every 4 weeks after till the score reduce to less than 12. LANSS will be sent to the subjects through RedCap software.

On their last study visit, participants will have an exit interview, in addition to completing study measures.

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M3B 3S6
        • Recruiting
        • Allevio Pain Management Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramin Safakish, MD. FRCPC
        • Sub-Investigator:
          • Gil Faclier, MD. FRCPC
        • Sub-Investigator:
          • Imrat Sohanpal, MD. FRCPC
        • Sub-Investigator:
          • Shadi Babazadeh, MD
        • Sub-Investigator:
          • Andriy Strilchuk, MD. NP
      • Toronto, Ontario, Canada, M3B 3S6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age 18-90;

Pain duration > 3 months

Cervical, Shoulder pain or cevicogenic Headache per Pain Diagram;

Two single blinded facet medial branch blocks (MBB) performed 30 days prior to the facet RF;

Subjects show 50% and more pain relief after each MBB (using VAS for this assessment);

Unsuccessful or poorly tolerated previous treatments including: pain control medications, chiropractic, osteopathy, massage therapy, physiotherapy, acupuncture, aqua therapy, Botox injection, and trigger point injection;

Exclusion Criteria:

Non-English speakers;

Refusal to sign informed consent;

Less than 50% pain relief after MBB (using VAS);

Variation in the dose of concomitant pain control medication less than 4 weeks before the procedure;

Allergy to medication or radiology contrast;

Patients with coagulation issues, those currently using anticoagulants and didn't stop them based on Allevio clinic's policy for anticoagulants;

Pregnant patients;

Any pain interventions including previous RF, MBB, infusions 90 days prior to the first MBB for the same area (Except failed Botox injection, and trigger point injection);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pulsed Radiofrequency Ablation
Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine with Maximum allowable temperature 50° rotation: 90.; Pulse rate: 3 Hz; pulse duration: 50 ms; 3 minutes
Procedure: Pulsed Radiofrequency Ablation
Radiofrequency ablation, also called rhizotomy, is a nonsurgical, minimally invasive procedure that uses heat to reduce or stop the transmission of pain. Radiofrequency waves ablate, or "burn," the nerve that is causing the pain, essentially eliminating the transmission of pain signals to the brain.
Other Names:
  • Continuous Radiofrequency Ablation
Active Comparator: Continuous Radiofrequency Ablation
Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine, burn will be made at 80° for 60 seconds.
Procedure: Pulsed Radiofrequency Ablation
Radiofrequency ablation, also called rhizotomy, is a nonsurgical, minimally invasive procedure that uses heat to reduce or stop the transmission of pain. Radiofrequency waves ablate, or "burn," the nerve that is causing the pain, essentially eliminating the transmission of pain signals to the brain.
Other Names:
  • Continuous Radiofrequency Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life measurement: Visual Analogue Scale
Time Frame: Beginning of the study , and every 3 months up to 12 months
Changes in Visual Analogue Scale (VAS), between minimum of zero and maximum of ten
Beginning of the study , and every 3 months up to 12 months
Quality of life measurement: Neck Disability Index
Time Frame: Beginning of the study , and every 3 months up to 12 months
Changes in the Neck Disability Index - AAOS(NDI_AAOS)
Beginning of the study , and every 3 months up to 12 months
Quality of life measurement: Short Form Brief Pain Inventory
Time Frame: Beginning of the study , and every 3 months up to 12 months
Changes in the Short Form Brief Pain Inventory (SF-BPI), between minimum of zero and maximum of ten
Beginning of the study , and every 3 months up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
At least 30% Changes in Pain Score
Time Frame: Beginning of the study , and every 3 months up to 12 months
Proportion of subjects who achieve at least a 30% decrease in the pain score measured by Visual analogue Scale , between minimum of zero and maximum of ten
Beginning of the study , and every 3 months up to 12 months
At least 30% Changes in Pain Score
Time Frame: Beginning of the study , and every 3 months up to 12 months
Proportion of subjects who achieve at least a 30% decrease in the pain score measured by Short Form Brief Pain Inventory , between minimum of zero and maximum of ten
Beginning of the study , and every 3 months up to 12 months
At least 30% Changes in Pain Score
Time Frame: Beginning of the study , and every 3 months up to 12 months
Proportion of subjects who achieve at least a 30% decrease in the pain score measured by The Neck Disability Index , between minimum of zero and maximum of ten
Beginning of the study , and every 3 months up to 12 months
At least 50% Changes in Pain Score
Time Frame: Beginning of the study , and every 3 months up to 12 months
Proportion of subjects who achieve at least a 50% decrease in the pain score measured by The Neck Disability Index
Beginning of the study , and every 3 months up to 12 months
At least 50% Changes in Pain Score
Time Frame: Beginning of the study , and every 3 months up to 12 months
Proportion of subjects who achieve at least a 50% decrease in the pain score measured by Short Form Brief Pain Inventory , between minimum of zero and maximum of ten
Beginning of the study , and every 3 months up to 12 months
At least 50% Changes in Pain Score
Time Frame: Beginning of the study , and every 3 months up to 12 months
Proportion of subjects who achieve at least a 50% decrease in the pain score measured by Visual analogue Scale , between minimum of zero and maximum of ten
Beginning of the study , and every 3 months up to 12 months
Changes in Changes in Global Improvement and Satisfaction
Time Frame: Beginning of the study , and every 3 months up to 12 months
Changes in Global Improvement and Satisfaction score measured by PGIC
Beginning of the study , and every 3 months up to 12 months
Changes in The Neck Disability Index
Time Frame: Beginning of the study , and every 3 months up to 12 months
Changes in The Neck Disability Index - AAOS(NDI_AAOS)
Beginning of the study , and every 3 months up to 12 months
Changes in General Anxiety Disorder Questionnaire
Time Frame: Beginning of the study , and every 3 months up to 12 months
Changes in General Anxiety Disorder Questionnaire (GAD)
Beginning of the study , and every 3 months up to 12 months
Changes in Beck's Depression Inventory
Time Frame: Beginning of the study , and every 3 months up to 12 months
Changes in Beck's Depression Inventory (BDI)
Beginning of the study , and every 3 months up to 12 months
Changes in Changes in Patients self-reported perceived duration of effect
Time Frame: Beginning of the study , and every 3 months up to 12 months
Changes in Patients self-reported perceived duration of effect (PSPDE)
Beginning of the study , and every 3 months up to 12 months
Adverse events
Time Frame: Beginning of the study , and every 3 months up to 12 months
Safety, assessed by the number, severity and duration of adverse reactions. It will be collected as self-rated health-related complaints by the subject and then confirmed medically. The causality will be assigned by the investigator
Beginning of the study , and every 3 months up to 12 months
Pain Medications
Time Frame: Beginning of the study , and every 3 months up to 12 months
Changes in pain medication use, if it is narcotic, measured by Morphine Equivalent Dose
Beginning of the study , and every 3 months up to 12 months
Changes in Leeds assessment of neuropathic symptoms and signs
Time Frame: 6 weeks after RF and if the score was 12 or higher repeat monthly up to 12 weeks
Changes in the Leeds assessment of neuropathic symptoms and signs (LANSS), between minimum of zero and maximum of twenty four
6 weeks after RF and if the score was 12 or higher repeat monthly up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allevio Pain Management Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2020

Primary Completion (Anticipated)

December 15, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

October 9, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 11, 2019

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16327-16:325610-06-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Results will be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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