Status:
COMPLETED
Safety and Efficacy of MRgFUS for the Treatment of Low Back Pain
Lead Sponsor:
InSightec
Conditions:
Lower Back Pain, Facets Joints Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Chronic pain affects an estimated 50 to 65 million individuals in the US, and its incidence and prevalence is steadily on the rise in correspondence with the increasing longevity of the population. Sp...
Detailed Description
This is a prospective, non-randomized, single-arm, phase I study to evaluate the safety and effectiveness of using ExAblate MRgFUS in the treatment of pain resulting from facet joint osteoarthritis. ...
Eligibility Criteria
Inclusion
- Men and women age 18 and older
- Patients who are able and willing to give consent and able to attend all study visits
- Patients who are able to communicate with the treating physician
- Patients must have chronic LBP attributed to facet joints.
- Patients with NRS (0-10 scale) LBP average score ≥ 4
- Patients with chronic LBP for at least 12 months.
- Patients with Oswestry Disability Questionnaire (ODQ) for LBP score \> 40%
- Targeted Facet joint to be treated is below L2 level
Exclusion
- Patients on dialysis
- Patients with evidence of lumbosacral radiculopathy on MRI or physical exam findings, including radicular leg pain
- Patients with 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 anesthetics
- Patients with motor deficit or any other indication for surgical intervention
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight \>113 kg)
- Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
- Patients under blood thinners other than Aspirin.
- Patients with compromised immune system.
- 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 severe cerebrovascular disease (CVA within last 6 months)
- Patients with severe hypertension (diastolic BP \> 100 on medication)
- Patients with known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
- 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 3 hrs.)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01232582
Start Date
October 1 2009
End Date
February 1 2012
Last Update
February 22 2012
Active Locations (2)
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1
Sheba MC
Ramat Gan, Israel, 52621
2
St. Mary's Hospital
London, United Kingdom