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

NCT01232582 | Completed Phase 2

• 1 other identifier: FJ001
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

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.

Conditions

Lower Back Pain, Facets Joints Osteoarthritis

Keywords

Lower back pain, Facets joints Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• Pain Scores on the Numerical Rating Scale

  12 months

• Quality of Life

  12 Months

Interventions

Exablate treatment DEVICE

MR guided Focused Ultrasound treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InSightec: lead

Study Sites (2)

Sheba MC

Ramat Gan, 52621, Israel

Location

St. Mary's Hospital

London, United Kingdom

Location

Related Links

• Sponsor's website

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sagi Harnof, MD

  Sheba MC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 2, 2010
• Study Start: October 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

GB (1); IL (1)