Chronic Low Back PainNCT03168802
MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain
A study testing MRgFUS ablation and Radiofrequency ablation in people with Chronic Low Back Pain and Facet Joint Syndrome, run by Taipei Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Chronic Low Back Pain, Facet Joint Syndrome
- What is being tested?
- MRgFUS ablation and Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Aug 2018to 25 Nov 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei medical university hospital
Taipei, Please Select, 11031
Meng-Huang Wu, MD, 227372181 ext. 3740, maxwutmu@gmail.com
About this study
Official title: Comparative Study of Magnetic Resonance-guided Focused Ultrasound and Radiofrequency Ablation for Treatment of Facet-joint Osteoarthritis Low Back Pain
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.
- Conditions
- Chronic Low Back Pain, Facet Joint Syndrome
- Being tested
- MRgFUS ablation, Radiofrequency ablation
- Keywords
- Focused ultrasound Ablation, Radiofrequency Ablation, Facet joint syndrome, Chronic low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRgFUS ablationProcedure or surgery
Focus ultrasound ablation therapy under MRI navigation for facet joint syndrome.
Radiofrequency ablationProcedure or surgery
Radiofrequency ablation therapy under C-arm navigation for facet joint syndrome.
| Study group | Role | What they receive |
|---|---|---|
| MRgFUS facet treatment | Experimental | MRgFUS ablation for facet joint pain once at Lumbar spine Receives: Procedure: MRgFUS ablation |
| Radiofrequency ablation facet treatment | Active comparator | Radiofrequency ablation for facet joint pain once at Lumbar spine Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score change: Numerical Rating Scale (NRS)
Efficacy
Measured: 24-week post-treatment
Secondary outcomes (7)
Pain score change: Numerical Rating Scale (NRS)
Efficacy
Measured: 1-, 4-, 8-, 12-, 36-, 52-week post-treatment
Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL)
Efficacy
Measured: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Functional scales change: Oswestry Disability Questionnaire (ODQ)
Efficacy
Measured: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Functional scales change: Core Outcome Measurement Index (COMI)
Efficacy
Measured: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Functional scales change: EQ5D Quality of Life questionnaires
Efficacy
Measured: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Amount of analgesic consumption
Efficacy
Measured: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Adverse event
Safety
Measured: 1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start24 Aug 2018
- Primary completion25 Nov 2025 (estimated)
- Study completion25 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 50 patients in each arm.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng-Huang Wu, Taipei Medical University Hospital
- Investigators
- Yen Yun, PhD, Study chair, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168802
- Sponsor's protocol ID
- N201609021
- Status last verified
- Dec 2024
- First submitted
- 10 Apr 2017
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22935902Kaye 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.
PubMed 27443328Krug 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.
PubMed 27054038Maas 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.
PubMed 26495910