MRgFUS and RFA for Treatment of Facet-joint Osteoarthritis Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-79
SponsorTaipei Medical University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
MRgFUS ablation
Procedure/SurgeryFocus ultrasound ablation therapy under MRI navigation for facet joint syndrome.
Radiofrequency ablation
Procedure/SurgeryRadiofrequency ablation therapy under C-arm navigation for facet joint syndrome.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: MRgFUS facet treatmentExperimental treatment 1 intervention
Group B: Radiofrequency ablation facet treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain score change: Numerical Rating Scale (NRS)
Efficacy
Time frame
24-week post-treatmentSecondary outcomes
1
Pain score change: Numerical Rating Scale (NRS)
Efficacy
Time frame
1-, 4-, 8-, 12-, 36-, 52-week post-treatment2
Functional scales change: Brief Pain Inventory-Quality of Life (BPI-QoL)
Efficacy
Time frame
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment3
Functional scales change: Oswestry Disability Questionnaire (ODQ)
Efficacy
Time frame
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment4
Functional scales change: Core Outcome Measurement Index (COMI)
Efficacy
Time frame
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatmentOther outcomes
1
Physical exams for back range of motion
Efficacy
Time frame
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatment2
X-ray for spine facet change
Efficacy
Time frame
1-, 4-, 8-, 12-, 24-, 36-, 52-week post-treatmentSponsors and contacts
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Source ClinicalTrials.gov