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

Primary Purpose

Lower Back Pain, Facets Joints Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Exablate treatment
Sponsored by
InSightec
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Back Pain, Facets Joints Osteoarthritis focused on measuring Lower back pain, Facets joints Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Sheba MC
  • St. Mary's Hospital

Outcomes

Primary Outcome Measures

Adverse events
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
Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS)
Quality of Life
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)

Full Information

First Posted
October 28, 2010
Last Updated
February 19, 2012
Sponsor
InSightec
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1. Study Identification

Unique Protocol Identification Number
NCT01232582
Brief Title
Safety and Efficacy of MRgFUS for the Treatment of Low Back Pain
Official Title
Safety and Efficacy of ExAblate MR Guided Focused Ultrasound for the Treatment of Low Back Pain Related to Facet Joint Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
InSightec

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain, Facets Joints Osteoarthritis
Keywords
Lower back pain, Facets joints Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Exablate treatment
Intervention Description
MR guided Focused Ultrasound treatment
Primary Outcome Measure Information:
Title
Adverse events
Description
Evaluate incidence and severity of adverse events associated with the ExAblate MRgFUS system used for the treatment of pain resulting from facet joint osteoarthritis.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain Scores on the Numerical Rating Scale
Description
Efficacy will be determined by the level of pain relief (as measured by the Numerical Rating Scale, NRS)
Time Frame
12 months
Title
Quality of Life
Description
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)
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sagi Harnof, MD
Organizational Affiliation
Sheba MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba MC
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
St. Mary's Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.insightec.com
Description
Sponsor's website

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

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