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Radiofrequency Ablation for Lower Back Pain
Study Summary
This trial is testing whether a new technology for radiofrequency ablation (RFA) is better than the conventional RFA technique for treating sacroiliac joint complex (SIJC) pain.
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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- You are getting paid for your pain treatment through disability or worker's compensation.My spinal fusion hardware is loose.I am an adult aged 18-90 with low back pain for over 3 months, and conservative treatments haven't worked.You had a severe allergic reaction to any medication in the past.I have a medical condition like stroke or severe lung disease that significantly limits my daily activities.You have a serious problem with addiction, severe depression, or experience hallucinations or delusions.I have been diagnosed with chronic widespread pain or a condition like fibromyalgia.I have pain in my hip due to arthritis.I am 18-90 years old and have had low back pain for over 3 months without relief from conservative treatments.I have not had an active bacterial infection or taken antibiotics in the last 4 weeks.My pain was reduced by half after specific spine injections.I have ongoing lower back pain that spreads down my leg.I will keep a pain diary to track how much relief I get from treatments.I use more than 50 mg of morphine-equivalent opioids daily.I have had a radiofrequency ablation procedure on my sacroiliac joint.You are currently involved in a legal case related to your pain.I will keep a pain diary to track how much relief I get from treatments.I have had surgery to fuse my sacroiliac joint.You are capable of understanding and providing consent in English and capable of complying with the outcome instruments used.My joint pain was halved by a specific guided injection.My average back pain score is 4 or more out of 10.
- Group 1: Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA)
- Group 2: Conventional Sacroiliac Joint Radiofrequency Ablation (C-SIJRFA)
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
To whom is enrollment in this trial available?
"The criteria for applicants of this medical trial are low back pain and an age range between 18 and 90. With 116 openings, the research is accepting a sizeable number of patients."
Is Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) a hazardous procedure for patients?
"Our evaluation at Power places the safety of Nimbus Sacroiliac Joint Radiofrequency Ablation (N-SIJRFA) as a 3 due to its status in Phase 4 clinical trials, which suggests it has been approved."
Can individuals younger than sixty years of age take part in this experiment?
"As indicated by the inclusion guidelines, people aged 18 to 90 years old may be eligible for enrolment in this trial."
What are the primary goals of this research undertaking?
"The three-month primary outcome of this research is the percent reduction in pain levels as monitored by a numerical rating scale. Secondary objectives include measuring the proportion of individuals who report at least 50% relief from their pain, evaluating clinically significant improvement according to EuroQol 5 Dimensions tool (EQ-5D), and examining how many participants rate themselves improved or much improved on Patient Global Impression of Change (PGIC)."
Are there any current vacancies for potential participants in this clinical trial?
"Affirmative. The clinicaltrials.gov website shows that the trial was first made public on August 15th 2022, and is currently recruiting 116 participants at 3 distinct sites."
What is the upper limit of individuals involved in this clinical examination?
"Affirmative. According to information on clinicaltrials.gov, this medical trial is actively enrolling patients who meet the eligibility criteria for inclusion. The study was initially posted on August 15th 2022 and most recently updated November 23rd 2022 - with a total of 116 participants being sought between 3 sites."
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