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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03168802
Other study ID # N201609021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 24, 2018
Est. completion date November 9, 2024

Study information

Verified date November 2023
Source Taipei Medical University Hospital
Contact Meng-Huang Wu, MD
Phone 227372181
Email maxwutmu@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. - Determining the effect of the MRgFUS System and RFA for improving functional disabilities and in reducing pain resulting from facet-joint osteoarthritis low back pain. Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS), decrease in analgesics/opiate, improved quality of life (as measured by the Oswestry Disability Questionnaire, ODQ, and core outcome measures index questionnaire, COMI), pain interference with function (as measured by the Brief Pain Inventory-Interference scale, BPI-QoL), general health status (as measured by the EQ5D), physical exam, X-ray and MRI studies from baseline up to 12-Months post- MRgFUS and radiofrequency treatment. - Evaluate incidence and severity of adverse events associated with the MRgFUS system and RFA used for the treatment of pain resulting from facet-joint osteoarthritis low back pain.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 9, 2024
Est. primary completion date November 9, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility 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).

Study Design


Intervention

Procedure:
MRgFUS ablation
Focus ultrasound ablation therapy under MRI navigation for facet joint syndrome.
Radiofrequency ablation
Radiofrequency ablation therapy under C-arm navigation for facet joint syndrome.

Locations

Country Name City State
Taiwan Taipei medical university hospital Taipei Please Select

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Kaye EA, Monette S, Srimathveeravalli G, Maybody M, Solomon SB, Gulati A. MRI-guided focused ultrasound ablation of lumbar medial branch nerve: Feasibility and safety study in a swine model. Int J Hyperthermia. 2016 Nov;32(7):786-94. doi: 10.1080/02656736.2016.1197972. Epub 2016 Jul 21. — View Citation

Krug R, Do L, Rieke V, Wilson MW, Saeed M. Evaluation of MRI protocols for the assessment of lumbar facet joints after MR-guided focused ultrasound treatment. J Ther Ultrasound. 2016 Apr 6;4:14. doi: 10.1186/s40349-016-0057-8. eCollection 2016. — View Citation

Maas ET, Ostelo RW, Niemisto L, Jousimaa J, Hurri H, Malmivaara A, van Tulder MW. Radiofrequency denervation for chronic low back pain. Cochrane Database Syst Rev. 2015 Oct 23;2015(10):CD008572. doi: 10.1002/14651858.CD008572.pub2. — View Citation

Weeks EM, Platt MW, Gedroyc W. MRI-guided focused ultrasound (MRgFUS) to treat facet joint osteoarthritis low back pain--case series of an innovative new technique. Eur Radiol. 2012 Dec;22(12):2822-35. doi: 10.1007/s00330-012-2628-6. Epub 2012 Aug 31. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Physical exams for back range of motion Efficacy 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Other X-ray for spine facet change Efficacy 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Primary Pain score change: Numerical Rating Scale (NRS) Efficacy 24-week post-treatment
Secondary Pain score change: Numerical Rating Scale (NRS) Efficacy 1-, 4-, 8-, 12-, 36-, 52-week post-treatment
Secondary Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL) Efficacy 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Secondary Functional scales change: Oswestry Disability Questionnaire (ODQ) Efficacy 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Secondary Functional scales change: Core Outcome Measurement Index (COMI) Efficacy 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Secondary Functional scales change: EQ5D Quality of Life questionnaires Efficacy 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Secondary Amount of analgesic consumption Efficacy 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Secondary Adverse event Safety 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
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