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This is a prospective, randomized, two-arm, phase II study.
The purpose of this study is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRgFUS facet treatment | Experimental | MRgFUS ablation for facet joint pain once at Lumbar spine |
|
| Radiofrequency ablation facet treatment | Active Comparator | Radiofrequency ablation for facet joint pain once at Lumbar spine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRgFUS ablation | Procedure | Focus ultrasound ablation therapy under MRI navigation for facet joint syndrome. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score change: Numerical Rating Scale (NRS) | Efficacy | 24-week post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score change: Numerical Rating Scale (NRS) | Efficacy | 1-, 4-, 8-, 12-, 36-, 52-week post-treatment |
| Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL) | Efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Physical exams for back range of motion | Efficacy | 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment |
| X-ray for spine facet change | Efficacy |
Inclusion Criteria:
Exclusion Criteria:
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:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng-Huang Wu, MD | Contact | 227372181 | 3740 | maxwutmu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yen Yun, PhD | Taipei Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei medical university hospital | Recruiting | Taipei | Please Select | 11031 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22935902 | Background | 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. | |
| 27443328 | Background | 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. |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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50 patients in each arm.
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| Radiofrequency ablation | Procedure | Radiofrequency ablation therapy under C-arm navigation for facet joint syndrome. |
|
| 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment |
| Functional scales change: Oswestry Disability Questionnaire (ODQ) | Efficacy | 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment |
| Functional scales change: Core Outcome Measurement Index (COMI) | Efficacy | 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment |
| Functional scales change: EQ5D Quality of Life questionnaires | Efficacy | 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment |
| Amount of analgesic consumption | Efficacy | 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment |
| Adverse event | Safety | 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment |
| 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment |
| 27054038 | Background | 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. |
| 26495910 | Background | 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. |