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Lower Back Pain, Facets Joints OsteoarthritisPhase 2NCT01232582

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

A Phase 2 study testing Exablate treatment in people with Lower Back Pain, Facets Joints Osteoarthritis, run by InSightec at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Exablate treatment
Type of treatment
Medical device
How many people
50 participants
Where
2 sitesin 2 countries
Study dates
Oct 2009to Feb 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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.)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Israel1 site

  • Sheba MC

    Ramat Gan, 52621

Other trials in Israel

United Kingdom1 site

  • St. Mary's Hospital

    London

Other trials in United Kingdom

About this study

Official title: Safety and Efficacy of ExAblate MR Guided Focused Ultrasound for the Treatment of Low Back Pain Related to Facet Joint Osteoarthritis

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).

Read more

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.

Read the 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

Being tested
Exablate treatment
Keywords
Lower back pain, Facets joints Osteoarthritis
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exablate treatmentDevice

    MR guided Focused Ultrasound treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (2)

  1. 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)

    Measured: 12 months

  2. 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)

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2010 (estimated)
  2. Study startOct 2009
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01232582
Sponsor's protocol ID
FJ001
Status last verified
Feb 2012
First submitted
28 Oct 2010
Last updated
22 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Exablate treatment in people with Lower Back Pain, Facets Joints Osteoarthritis, run by InSightec at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01232582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.

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