Safety and efficacy of Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) for the treatment of chronic low back pain originating in lumbar facet joint osteoarthritis of elderly patients.

Safety and efficacy of Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) for the treatment of chronic low back pain originating in lumbar facet joint osteoarthritis of elderly patients. - Safety and efficacy of MRgFUS for the treatment of chronic lumbar facet joint pain

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015416

Enrollment

Registered

2014-10-13

Start date

2009-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic low back pain (LBP), Facet joint osteoarthritis

Interventions

MRgFUS treatment using ExAblate 2000 system

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Men and women age 65 years and older 2) Patients who are able and willing to give consent and able to attend all study visits 3) Patients with chronic low back pain (LBP) for at least 6 months 4) Patients with LBP worst score >= 4 on NRS (0-10 scale) 5) Patients must have chronic LBP originating in lumbar facet joints 6) Patients with localized pressure pain on the facet joints (<= 2)

Exclusion criteria

Exclusion criteria: 1) Patients with evidence of lumbosacral radiculopathy on MRI or physical exam findings, including radicular leg pain 2) Patients with motor deficit or any other indication for surgical intervention 3) Patients with existing malignancy 4) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight >113 kg) 5) Patients on dialysis 6) Patients with an active infection or severe hematological, neurological, or other uncontrolled disease 7) Patients with unstable cardiac status 8) Patients with severe hypertension 9) Patients with severe cerebrovascular disease 10) Patients with severe coagulation disorder or on anticoagulant and antiplatelet therapy 11) Patients unable to communicate with the investigator and staff 12) Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.) 13) Any patients disqualified by a study physician because of medical, psychological, or any other reason

Design outcomes

Primary

Measure	Time frame
Adverse events [Time frame: 6 months]	—

Secondary

Measure	Time frame
Pain scores on Numeric Rating Scale (NRS) Quality of life, measured by the Oswestry Disability index (ODI), Brief Pain Inventory-interference scale (BPI-QoL) and EuroQOL-5 dimension (EQ-5D) [Time frame: 6 months]	—

Countries

Japan

Contacts

Public ContactMotohiro Kawasaki

Kochi Medical School, Kochi University Department of Orthopaedic Surgery

im35@kochi-u.ac.jp0888-80-2386

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026