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Procedure

Radiofrequency Neurotomy for Facetogenic Headache

N/A

Recruiting

Research Sponsored by Allevio Pain Management Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after rf and if the score was 12 or higher repeat monthly up to 12 weeks

Awards & highlights

Study Summary

This trial suggests that patients with facet mediated cervicogenic headaches may benefit from a repeat cervical facet radiofrequency neurotomy, with a success rate of 86%.

Who is the study for?

This trial is for adults aged 18-90 with chronic neck, shoulder pain or cervicogenic headaches lasting over 3 months. Participants must have had some relief from two medial branch blocks and not responded well to other treatments like medications or physical therapies. Pregnant individuals, non-English speakers, those who refuse consent, allergy sufferers, patients with coagulation issues on anticoagulants that can't be stopped as per clinic policy are excluded.Check my eligibility

What is being tested?

The study compares Pulsed Radiofrequency Ablation (P-RF) against Continuous Radiofrequency Neurotomy (C-RF) in treating cervical facet joint-mediated pain. It aims to determine which method offers better pain control by reviewing previous studies where C-RF showed higher success rates than P-RF for conditions like trigeminal neuralgia and occipital neuralgia.See study design

What are the potential side effects?

While the specific side effects of P-RF and C-RF aren't detailed here, radiofrequency ablation procedures may include temporary increased nerve pain, numbness or tingling near the injection site, infection risk at the needle insertion point, mild backache or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had two specific spine injections 30 days before a spine procedure.

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I experience over 50% pain relief after each medial branch block.

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I am between 18 and 90 years old.

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I am between 18 and 90 years old.

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My pain has lasted for more than 3 months.

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I have pain in my neck, shoulder, or headaches originating from my neck.

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I have tried treatments like pain meds, massage, acupuncture without success or couldn't tolerate them.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks after rf and if the score was 12 or higher repeat monthly up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks after rf and if the score was 12 or higher repeat monthly up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after rf and if the score was 12 or higher repeat monthly up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quality of life measurement: Neck Disability Index

Quality of life measurement: Short Form Brief Pain Inventory

Quality of life measurement: Visual Analogue Scale

Secondary outcome measures

Adverse events

At least 30% Changes in Pain Score

At least 50% Changes in Pain Score

+7 more

Trial Design

2Treatment groups

Active Control

Group I: Continuous Radiofrequency AblationActive Control1 Intervention

Radiofrequency ablation of sensory nerves at minimum 3 levels of cervical spine, burn will be made at 80° for 60 seconds.

Group II: Pulsed Radiofrequency AblationActive Control1 Intervention

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Allevio Pain Management ClinicLead Sponsor

3 Previous Clinical Trials

266 Total Patients Enrolled

Media Library

Pulsed Radiofrequency Ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04124445 — N/A

Chronic Shoulder Pain Research Study Groups: Continuous Radiofrequency Ablation, Pulsed Radiofrequency Ablation

Chronic Shoulder Pain Clinical Trial 2023: Pulsed Radiofrequency Ablation Highlights & Side Effects. Trial Name: NCT04124445 — N/A

Pulsed Radiofrequency Ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04124445 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment currently available for this research study?

"Affirmative. Records found on clinicaltrials.gov reveal that this medical investigation, which was first posted on February 10th 2020, is actively recruiting patients for participation. At 2 different research sites, approximately 88 people are required to join the study."

Answered by AI

Are elderly persons of advanced age being considered for inclusion in this medical experiment?

"The qualifications for participation in this clinical trial demand that applicants are between 18 and 90 years of age. There are 22 trials specifically catered to minors and 196 studies targeting the elderly population."

Answered by AI

Are there any restrictions on who can sign up for this medical experiment?

"This clinical trial is seeking 88 participants who suffer from facial-genic headaches and are between 18 to 90 years old."

Answered by AI

What is the intended outcome of this medical experiment?

"This clinical trial's primary aim is to assess patients' quality of life via the Neck Disability Index. Secondary objectives are changes in Beck's Depression Inventory, a minimum 30% reduction in pain scores as measured by The Neck Disability Index (ranging from 0-10), and alterations in narcotics usage using Morphine Equivalent Dose. Data will be collected at baseline and every 3 months up until 12 months post treatment."

Answered by AI

How many people are the maximum amount allowed to join this clinical experiment?

"Affirmative. According to clinicaltrials.gov records, this medical study is currently recruiting participants - the initial post was made on February 10th 2020 and the last edit occurred June 22nd 2022. A total of 88 patients need to be recruited across 2 sites."

Answered by AI