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Safety and Efficacy of MRgFUS for the Treatment of Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01232582
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : February 22, 2012
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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. Spinal pain, encompassing lower back, thoracic and neck pain, is a very common type of chronic pain that can greatly reduce quality of life. Facet joint pain is most often associated with facet arthropathy or degenerative arthritis of the joint. This condition develops due to progressive wear and tear caused by the small but repetitive strain of the joints throughout a lifetime. Strain and inflammation can induce fluid distention of the joints which in turn can result in compression of the nerve roots of the joint - the origin of the chronic pain.

Current treatments for facet arthropathy and pain include oral medications, intra-articular injections of anesthetic or steroid medications, energy ablation (e.g. radiofrequency ablation) for denervation, and in some severe cases facet rhizotomy (surgical severing of the nerves).

The ExAblate magnetic resonance guided focused ultrasound system enables noninvasive focal ablation of tissue. Results from feasibility studies, including those from the FDA approved feasibility study (IDE # G050177) have shown the palliative effect of the ExAblate for patients with bone metastases. It is reasonable to assume that this palliative effect of MRgFUS could also translate to the alleviation of facet pain if focused ultrasound beams are directed to the facet joints. The highly-target focal ablation could also diminish the risk of complications that are often associated with other less selective denervation techniques.

The objective of this trial is to evaluate the safety and effectiveness of the ExAblate system and the treatment of pain resulting from facet joint osteoarthritis.

Condition or disease Intervention/treatment Phase
Lower Back Pain, Facets Joints Osteoarthritis Device: Exablate treatment Phase 2

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.

Patients with chronic LBP associated with one or more lumbar zygapophysial joints that meet all eligibility requirements and have given their written informed consent will be enrolled to the study.

All patients will be treated and followed for 12-months post treatment. A total of 50 patients will be enrolled at up to two clinical sites.

The primary objective of this study is to evaluate incidence and severity of adverse events associated with the ExAblate MRgFUS system used for the treatment of pain resulting from facet joint osteoarthritis

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of ExAblate MR Guided Focused Ultrasound for the Treatment of Low Back Pain Related to Facet Joint Osteoarthritis
Study Start Date : October 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Exablate treatment
    MR guided Focused Ultrasound treatment

Primary Outcome Measures :
  1. Adverse events [ Time Frame: 12 months ]
    Evaluate incidence and severity of adverse events associated with the ExAblate MRgFUS system used for the treatment of pain resulting from facet joint osteoarthritis.

Secondary Outcome Measures :
  1. Pain Scores on the Numerical Rating Scale [ Time Frame: 12 months ]
    Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS)

  2. Quality of Life [ Time Frame: 12 Months ]
    Quality of life will be measured by the Oswestry Disability Questionnaire (ODQ), SF-12 Health Survey and pain interference with function (as measured by the Brief Pain Inventory - Interference scale, BPI-QoL)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men and women age 18 and older
  2. Patients who are able and willing to give consent and able to attend all study visits
  3. Patients who are able to communicate with the treating physician
  4. Patients must have chronic LBP attributed to facet joints.
  5. Patients with NRS (0-10 scale) LBP average score ≥ 4
  6. Patients with chronic LBP for at least 12 months.
  7. Patients with Oswestry Disability Questionnaire (ODQ) for LBP score > 40%
  8. Targeted Facet joint to be treated is below L2 level

Exclusion Criteria:

  1. Patients on dialysis
  2. Patients with evidence of lumbosacral radiculopathy on MRI or physical exam findings, including radicular leg pain
  3. Patients with RF treatment for LBP within the last 6 months
  4. Patients with previous low back surgery
  5. Patients who are pregnant
  6. Patients with existing malignancy
  7. Patients with allergies to relevant anesthetics
  8. Patients with motor deficit or any other indication for surgical intervention
  9. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight >113 kg)
  10. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
  11. Patients under blood thinners other than Aspirin.
  12. Patients with compromised immune system.
  13. 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
  14. Patients with severe cerebrovascular disease (CVA within last 6 months)
  15. Patients with severe hypertension (diastolic BP > 100 on medication)
  16. Patients with known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease
  17. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
  18. Patients unable to communicate with the investigator and staff.
  19. Patients who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01232582

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Sheba MC
Ramat Gan, Israel, 52621
United Kingdom
St. Mary's Hospital
London, United Kingdom
Sponsors and Collaborators
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Principal Investigator: Sagi Harnof, MD Sheba MC
Additional Information:
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Responsible Party: Nadir Alikacem, Insightec Identifier: NCT01232582    
Other Study ID Numbers: FJ001
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by InSightec:
Lower back pain, Facets joints Osteoarthritis
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations