Using focused ultrasound and radiofrequency to treat low back pain from facet joint issues

Comparative Study of Magnetic Resonance-guided Focused Ultrasound and Radiofrequency Ablation for Treatment of Facet-joint Osteoarthritis Low Back Pain

This study is testing whether focused ultrasound or radiofrequency treatment can help people with low back pain from facet joint issues feel better and improve their daily life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 20 Years to 79 Years
• Sex: All
• Sponsor: Taipei Medical University Hospital (other)
• Locations: 1 site (Taipei, Please Select)
• Trial ID: NCT03168802 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of magnetic resonance-guided focused ultrasound (MRgFUS) compared to radiofrequency ablation (RFA) for patients suffering from facet-joint osteoarthritis low back pain. It is a prospective, randomized, two-arm study that aims to measure pain relief, functional improvement, and quality of life over a 12-month period. Participants will be assessed using various pain and disability scales, including the Numerical Rating Scale and the Oswestry Disability Questionnaire. The study will include imaging studies to confirm the presence of facet osteoarthritis.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 20 to 79 with chronic low back pain from facet joint syndrome lasting at least six months.

Not a fit: Patients with lumbosacral radiculopathy, significant motor deficits, or those who have had previous low back surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, less invasive treatment option for patients suffering from chronic low back pain due to facet joint syndrome.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific comparison of MRgFUS and RFA is novel.

Eligibility criteria

Inclusion Criteria:

1. Men and women age 20 to 79 years old
2. Suffering from lumbar vertebral facet joint syndrome.
3. Lower back pain at least six months (NRS≥4).
4. Conventional treatment of pain includes NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic therapy.
5. Imaging of the spine have facet osteoarthritis.
6. Referred pain is no more below the knee.
7. At least once when local anesthesia or diagnostic medial nerve branch injection, pain reduction\> 75% (0.5ml of 2% lidocaine).

Exclusion Criteria:

1. Patients with evidence of lumbosacral radiculopathy on MRI, CT or physical exam findings, including radicular leg pain.
2. Patients with motor deficit or any other indication for surgical intervention.
3. Patients with MRgFUS or RF treatment for LBP within the last 6 months.
4. Patients with previous low back surgery.
5. Patients who are pregnant.
6. Patients with existing malignancy.
7. Patients with allergies to relevant contrast, anesthetics, sedation drugs.
8. Patients with contraindications for MRI.
9. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
10. 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
11. Patients with severe cerebrovascular disease (CVA within last 6 months)
12. Patients with severe hypertension (diastolic BP \> 100 on medication)
13. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
14. Patients unable to communicate with the investigator and staff.
15. Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.)
16. Coagulation disorders or other bleeding disorders, use of anticoagulants or antiplatelet drugs within 5 days before treatment.
17. When local anesthesia or diagnostic medial nerve branch injection, the pain does not reach 75% (0.5 mL of 2% lidocaine).

Where this trial is running

Taipei, Please Select

• Taipei medical university hospital — Taipei, Please Select, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Meng-Huang Wu, MD

Conditions: Chronic Low Back Pain, Facet Joint Syndrome, Focused ultrasound Ablation, Radiofrequency Ablation, Facet joint syndrome, Chronic low back pain