Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
InSightec
ClinicalTrials.gov Identifier:
NCT01232582
First received: October 28, 2010
Last updated: February 19, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Lower Back Pain, Facets Joints Osteoarthritis
Device: Exablate treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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:
  • Pain Scores on the Numerical Rating Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS)

  • Quality of Life [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 50
Study Start Date: October 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Exablate treatment
    MR guided Focused Ultrasound treatment
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232582

Locations
Israel
Sheba MC
Ramat Gan, Israel, 52621
United Kingdom
St. Mary's Hospital
London, United Kingdom
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: Sagi Harnof, MD Sheba MC
  More Information

Additional Information:
No publications provided

Responsible Party: Nadir Alikacem, Insightec
ClinicalTrials.gov Identifier: NCT01232582     History of Changes
Other Study ID Numbers: FJ001
Study First Received: October 28, 2010
Last Updated: February 19, 2012
Health Authority: Israel: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by InSightec:
Lower back pain, Facets joints Osteoarthritis

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Rheumatic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014