NCT01590004

Brief Summary

This study aims to develop a technical description of lumbar medial branch ablation using the LumbarCool system. The procedure uses cooled radiofrequency (cooled-RF) technology in treating patients with diagnosed lumbar facet joint pain.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

3.6 years

First QC Date

April 30, 2012

Last Update Submit

May 18, 2015

Conditions

Lumbar Facet Joint Pain

Keywords

LumbarCool systemCooled radiofrequency medial ablationCooled-RF neurotomy

Outcome Measures

Primary Outcomes (1)

  • Confirm acute safety of the procedure

    The primary outcome is to confirm acute safety of the procedure utilizing the neurological exam. The following outcome measures will also be used to confirm there are no safety concerns at one month and 3 months follow-up visits: * Pain intensity using the Numerical Rating Scale (NRS) * Change in medication usage * Assessment of adverse device effects, including neurological exam (light touch/pin prick, strength, straight leg test, gait, heel to toe/straight-line walking, heel to shin) (immediately post procedure, 1 month and 3 months).

    Baseline to 3 months post procedure.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients of Medical Advanced Pain Specialists, PA (MAPS)

You may qualify if:

  • Literate
  • Aged between 18 and 75 years
  • Chronic lumbar pain for \> 6 months
  • day average NRS score at least 4 and not greater than 8
  • Clinical features consistent with possible lumbar z-joint pain (such as pain and tenderness over not more than three segments unilaterally)
  • No adequate relief with conservative management, including physical therapy, chiropractic manipulation, exercises, and drug therapy
  • Understand and tolerate lumbar medial branch diagnostic blocks
  • Positive for lumbar zygapophyseal joint pain after comparative diagnostic blocks (≥ 80% pain relief) per standard of care.
  • Understands study protocol and provides voluntary written consent to participate in study and outcome measurements
  • Normal neurological exam
  • Understands and agrees to use an acceptable form of birth control

You may not qualify if:

  • Current pregnancy, currently breast feeding or the intent of becoming pregnant during the study period
  • Prior posterior lumbar fusion
  • Prior low back surgery
  • Concurrent cervical or thoracic pain or pain in these regions lasting longer than 2 weeks during the last 6 months
  • Compensable disability or work injury or ongoing litigation
  • Prior treatment with radiofrequency neurotomy in the lumbar region within 3 months
  • Discogenic pain verified by controlled discography
  • Sources of pain not in the lumbar spine
  • Leg pain greater than back pain
  • Obvious inappropriate pain behavior during physical exam
  • Neurologic deficits
  • Positive straight leg raising result
  • Any features of upper motor neuron lesion
  • Gait abnormality not attributable to spinal pain
  • Severe Central Spinal Canal Stenosis (\> 50%) evident on prior computed tomogram or magnetic resonance image
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAPS Applied Research Center, Inc.

Edina, Minnesota, 55435, United States

RECRUITING

Study Officials

  • Mehul J Desai, MD

    MAPS Applied Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehul J Desai, MD

CONTACT

(301)588-7888mehuljdesaimd@gmail.com

Nicholas J Peterson, BS

CONTACT

(414) 325-3724nicholas.peterson@apmhealth.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 2, 2012

Study Start

August 1, 2012

Primary Completion

March 1, 2016

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

US(1)