MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain
NCT ID: NCT03168802
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2018-08-24
2025-11-25
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MRgFUS facet treatment
MRgFUS ablation for facet joint pain once at Lumbar spine
MRgFUS ablation
Focus ultrasound ablation therapy under MRI navigation for facet joint syndrome.
Radiofrequency ablation facet treatment
Radiofrequency ablation for facet joint pain once at Lumbar spine
Radiofrequency ablation
Radiofrequency ablation therapy under C-arm navigation for facet joint syndrome.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Suffering from lumbar vertebral facet joint syndrome.
3. Lower back pain at least six months (NRSā„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
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).
20 Years
79 Years
ALL
No
Sponsors
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Taipei Medical University Hospital
OTHER
Responsible Party
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Meng-Huang Wu
Principal Investigator
Principal Investigators
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Yen Yun, PhD
Role: STUDY_CHAIR
Taipei Medical University
Locations
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Taipei medical university hospital
Taipei, Please Select, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Meng-Huang Wu, MD
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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N201609021
Identifier Type: -
Identifier Source: org_study_id