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New treatment option for Chronic Low Back Pain
Official title MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain
ClinicalTrials.gov ID: NCT03168802
What this study is testing
- What it's testing
- This is a prospective, randomized, two-arm, phase II study. The purpose of this study is: To evaluate and compare the efficacy and safety of magnetic resonance-guided focused ultrasound (MRgFUS) and radiofrequency ablation (RFA) for treatment of facet-joint osteoarthritis low back pain.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 79
You may be able to join if
- Men and women age 20 to 79 years old
- Suffering from lumbar vertebral facet joint syndrome.
- Lower back pain at least six months (NRS≥4).
- Conventional treatment of pain includes NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic therapy.
- Imaging of the spine have facet osteoarthritis.
You likely can't join if
- Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain.
- Patients with motor deficit or any other indication for surgical intervention.
- Patients with MRgFUS or RF treatment for LBP within the last 6 months.
- Patients with previous low back surgery.
- Patients who are pregnant.
- Patients with existing malignancy.
See the full eligibility criteria
- Men and women age 20 to 79 years old
- Suffering from lumbar vertebral facet joint syndrome.
- Lower back pain at least six months (NRS≥4).
- Conventional treatment of pain includes NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic therapy.
- Imaging of the spine have facet osteoarthritis.
- Referred pain is no more below the knee.
- At least once when local anesthesia or diagnostic medial nerve branch injection, pain reduction\> 75% (0.5ml of 2% lidocaine).
- Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain.
- Patients with motor deficit or any other indication for surgical intervention.
- Patients with MRgFUS or RF treatment for LBP within the last 6 months.
- Patients with previous low back surgery.
- Patients who are pregnant.
- Patients with existing malignancy.
- Patients with allergies to relevant contrast, anesthetics, sedation drugs.
- Patients with contraindications for MRI.
- Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
- Patients with unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction less than 40 days prior to protocol enrolment
- Patients with Severe Congestive Heart Failure, NYHA class 4.
- Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status
- Patients with pacemaker
- Patients with severe cerebrovascular disease (CVA within last 6 months)
- Patients with severe hypertension (diastolic BP \> 100 on medication)
- Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
- Patients unable to communicate with the investigator and staff.
- Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
- Coagulation disorders or other bleeding disorders, use of anticoagulants or antiplatelet drugs within 5 days before treatment.
- When local anesthesia or diagnostic medial nerve branch injection, the pain does not reach 75% (0.5 mL of 2% lidocaine).
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Please Select, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Please Select, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.