What side effects are associated with this type of intervention?

Common treatments for chronic shoulder pain that involve nerve ablation, such as Cervical Facet Radiofrequency (C-RF), can have side effects including temporary pain at the injection site, numbness, muscle weakness, and, in rare cases, infection or nerve damage. Patients may also experience a temporary increase in pain before relief is achieved. Proper patient selection and adherence to procedural protocols are essential to minimize these risks.

What prior FDA approvals exist?

The FDA has approved various treatments for chronic pain that involve the ablation of nerve tissue to interrupt pain signals, similar to Cervical Facet Radiofrequency (C-RF). One such treatment is radiofrequency ablation (RFA), which is used to treat chronic pain by targeting specific nerves. While specific FDA approvals for chronic shoulder pain are not detailed, RFA is commonly used for various chronic pain conditions, including spinal and joint pain. Additionally, treatments like epidural steroid injections and nerve blocks, which are also used for chronic pain management, have received FDA approval and are widely utilized in clinical practice.

What other types of research exist?

Promising novel alternatives to Cervical Facet Radiofrequency (C-RF) for chronic shoulder pain include: 1) Extracorporeal Shock Wave Therapy (ESWT), which has shown efficacy in treating chronic rotator cuff tendonitis. 2) Acupuncture, which has been systematically reviewed and found effective for lateral elbow pain, and may be applicable to shoulder pain. 3) Botulinum Toxin A injections, which have been studied for chronic radial epicondylitis and could be considered for shoulder pain. 4) Prolotherapy, which has shown promise in treating chronic musculoskeletal pain and lateral epicondylosis. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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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)

Must not have

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

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)

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

No Placebo-Only Group

Summary

This trial compares two treatments, PRF and CRF, which use electrical currents to reduce chronic neck pain by numbing the nerves. It targets patients with conditions like cervicogenic headache or occipital neuralgia who may not respond well to other treatments. Pulsed radiofrequency (PRF) was introduced as a non-destructive alternative to continuous radiofrequency (CRF) energy for treating chronic pain.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have blood clotting issues and haven't stopped my anticoagulants as per clinic policy.

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I haven't had pain treatments like RF or infusions for the same area in the last 90 days, except for Botox or trigger point injections.

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I do not speak English.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of life measurement: Neck Disability Index

Quality of life measurement: Short Form Brief Pain Inventory

Quality of life measurement: Visual Analogue Scale

Secondary study objectives

Adverse events

At least 30% Changes in Pain Score

At least 50% Changes in Pain Score

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cervical Facet Radiofrequency (C-RF) works by applying heat generated through radiofrequency waves to nerve tissues, effectively ablating them to interrupt pain signals from reaching the brain. This method is particularly useful for chronic shoulder pain as it targets the specific nerves responsible for transmitting pain, providing significant and often long-lasting relief. Other common treatments include physical therapy, which improves shoulder function and reduces pain through exercises that enhance strength and flexibility, and corticosteroid injections, which reduce inflammation and pain by delivering anti-inflammatory medication directly to the affected area. Understanding these mechanisms is crucial for chronic shoulder pain patients as it helps them and their healthcare providers choose the most appropriate treatment based on the underlying cause of their pain and their specific medical needs.

Manual treatment for cervicogenic headache and active trigger point in the sternocleidomastoid muscle: a pilot randomized clinical trial.Pulsed radiofrequency application in treatment of chronic zygapophyseal joint pain.Pulsed and continuous radiofrequency current adjacent to the cervical dorsal root ganglion of the rat induces late cellular activity in the dorsal horn.