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Radiofrequency Ablation Techniques for Neck Pain
Study Summary
This trial is comparing the effectiveness of two different types of radiofrequency ablation (RFA) for treating cervical facet pain. The first type is the conventional RFA, which has been studied and shown to be effective in the past. The second type is a newer RFA called Trident, which is designed to be more efficient and safe while still maintaining a large ablative lesion. The trial will compare the two types of RFA in terms of pain relief, functionality, and patient perception of improvement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have been diagnosed with chronic widespread pain or a condition like fibromyalgia.I am 18 or older, understand English, and can follow the study's procedures.You have a pacemaker or neurostimulator.I have had a neck nerve pain treatment with heat.I need sedation through an IV for procedures.My average neck pain score is 4 or more out of 10.I have had neck pain for at least 3 months that does not spread to my arms.You are allergic to the dye used for imaging tests or to local numbing medications.I do not have an infection in my body at the time of the procedure.I do not have any uncontrolled bleeding disorders.The doctor will decide the appropriate tests based on your symptoms, physical exam, and imaging results.My procedure will follow Spine Intervention Society guidelines.I am keeping a pain diary to track how much relief I get.I have had neck pain for at least 3 months that does not spread to my arms.Your neck pain is consistently rated 4 out of 10 or higher on average over the past 7 days.You have very serious depression or experience hallucinations or delusions.You use more than 50 morphine equivalents of opiate medication every day.You are getting paid for your pain treatment, such as disability or compensation for a work or car accident injury.I responded well to two separate nerve block tests with lidocaine and bupivacaine.My pain relief from lidocaine lasts at least 1 hour and from bupivacaine at least 2 hours.
- Group 1: Trident Cervical Medial Branch Radiofrequency Ablation
- Group 2: Conventional Cervical Medial Branch Radiofrequency Ablation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this clinical experiment currently offer participation opportunities to individuals?
"Affirmative. Clinicaltrials.gov attests that this research study, which was first advertised on April 28th 2022, is presently recruiting participants. Approximately 80 volunteers are necessary to be enrolled from 3 distinct medical locations."
What are the core objectives of this research trial?
"This clinical trial's primary focus is to evaluate the efficacy of Pain response across a 3, 6 and 12 month period. Secondary assessments include Procedural Radiation Dose (various radiation levels during T-CMBRFA versus C-CMBRFA.), Procedure time comparisons between different treatments, and Post Procedure Patient Impression of Change as measured via Patient Global Impression of Change scores."
How many participants are there in the current experiment?
"Correct. According to the information available at clinicaltrials.gov, this medical trial is actively looking for candidates and was initially posted on April 28th 2022. 80 patients need to be recruited from 3 separate sites."
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