Status:
UNKNOWN
Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain
Lead Sponsor:
Allevio Pain Management Clinic
Conditions:
Faceto-genic Neck Pain
Shoulder Pain Chronic
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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). Anoth...
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 R...
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04124445
Start Date
February 10 2020
End Date
December 31 2025
Last Update
June 23 2022
Active Locations (2)
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1
Allevio Pain Management Clinic
Toronto, Ontario, Canada, M3B 3S6
2
Allevio Pain Management
Toronto, Ontario, Canada, M3B 3S6