Comparing two methods of radiofrequency treatment for neck and shoulder pain
Pulsed vs Continuous Radiofrequency Neurotomy for Cervical Facet Joint Mediated Pain: a Single-blind Randomized Controlled Clinical Trial
This study is testing which method of radiofrequency treatment, Pulsed or Continuous, works better for people with neck and shoulder pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Allevio Pain Management Clinic Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT04124445 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of Pulsed Radiofrequency Ablation (PRF) versus Continuous Radiofrequency Ablation (CRF) in treating cervical facet joint-mediated pain, including neck pain, shoulder pain, and cervicogenic headaches. Eligible patients will be randomly assigned to one of the two treatment groups after undergoing medial branch blocks to assess their pain relief. The study will utilize a blinded approach for patients, with treatment success evaluated through questionnaires administered every three months. The recruitment process is expected to take 15-24 months, depending on the sample size achieved.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 with chronic cervical, shoulder pain, or cervicogenic headaches who have not found relief from previous treatments.
Not a fit: Patients who do not experience at least 50% pain relief after initial medial branch blocks will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective pain management option for chronic cervical and shoulder pain.
How similar studies have performed: Previous studies have shown varying success rates for radiofrequency treatments, indicating that while this approach has been tested, the specific comparison of PRF and CRF is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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);
Where this trial is running
Toronto, Ontario and 1 other locations
- Allevio Pain Management Clinic — Toronto, Ontario, Canada (Recruiting)
- Allevio Pain Management — Toronto, Ontario, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.