Recruiting

Pulsed vs. Continuous

Sponsor:

Allevio Pain Management Clinic

Code:

NCT04124445

Conditions

Faceto-genic Neck Pain

Shoulder Pain Chronic

Faceto-genic Headache

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pulsed Radiofrequency Ablation

Study Details

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). 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).

Conditions

Faceto-genic Neck Pain

Shoulder Pain Chronic

Faceto-genic Headache

Study ID

NCT04124445

Start date

Feb 10, 2020

Status verified date

May, 2022

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

Interventions

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.

Primary outcome measure

  • Quality of life measurement: Visual Analogue Scale [ Time Frame: 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 ]
  • Quality of life measurement: Short Form Brief Pain Inventory [ Time Frame: Beginning of the study , and every 3 months up to 12 months ]

Central Contacts and Locations

Locations

Allevio Pain Management Clinic

Recruiting

Toronto, Ontario, Canada, M3B 3S6

Contacts

Principal Investigator:

Ramin Safakish, MD. FRCPC

Allevio Pain Management

Recruiting

Toronto, Ontario, Canada, M3B 3S6

Contacts

More Information

Sponsor

Allevio Pain Management Clinic

Last update posted

Jun 23, 2022

Last verified

May, 2022

Keywords

  • Faceto-genic Cervical pain
  • Chronic pain
  • Pulsed Radiofrequency ablation
  • Continues Radiofrequency ablation
  • Medial Brunch Block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Allevio Pain Management Clinic on 2022-06-23.