Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by International Spine, Pain and Performance Center
Sponsor:
Collaborator:
Kimberly-Clark Corporation
Information provided by (Responsible Party):
International Spine, Pain and Performance Center
ClinicalTrials.gov Identifier:
NCT01590004
First received: April 30, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition
Lumbar Facet Joint Pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain

Further study details as provided by International Spine, Pain and Performance Center:

Primary Outcome Measures:
  • Confirm acute safety of the procedure [ Time Frame: Baseline to 3 months post procedure. ] [ Designated as safety issue: Yes ]

    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).


Estimated Enrollment: 10
Study Start Date: August 2012
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Detailed Description:

This is a prospective, open-label, single center clinical study to be enrolled at George Washington University Medical Center. This study will consist of 10 patients and each patient will be assessed at pre-treatment, pre-discharge, and at 1 and 3 months post treatment. Outcomes to be evaluated include: pain severity, disability, and the occurrence of adverse events.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients of the George Washington Spine and Pain Center

Criteria

Inclusion Criteria:

  1. Literate
  2. Aged between 18 and 75 years
  3. Chronic lumbar pain for > 6 months
  4. 3-day average NRS score at least 4 and not greater than 8
  5. Clinical features consistent with possible lumbar z-joint pain (such as pain and tenderness over not more than three segments unilaterally)
  6. No adequate relief with conservative management, including physical therapy, chiropractic manipulation, exercises, and drug therapy
  7. Understand and tolerate lumbar medial branch diagnostic blocks
  8. Positive for lumbar zygapophyseal joint pain after comparative diagnostic blocks (≥ 80% pain relief) per standard of care.
  9. Understands study protocol and provides voluntary written consent to participate in study and outcome measurements
  10. Normal neurological exam
  11. Understands and agrees to use an acceptable form of birth control

Exclusion Criteria:

  1. Current pregnancy, currently breast feeding or the intent of becoming pregnant during the study period
  2. Prior posterior lumbar fusion
  3. Prior low back surgery
  4. Concurrent cervical or thoracic pain or pain in these regions lasting longer than 2 weeks during the last 6 months
  5. Compensable disability or work injury or ongoing litigation
  6. Prior treatment with radiofrequency neurotomy in the lumbar region within 3 months
  7. Discogenic pain verified by controlled discography
  8. Sources of pain not in the lumbar spine
  9. Leg pain greater than back pain
  10. Obvious inappropriate pain behavior during physical exam
  11. Neurologic deficits
  12. Positive straight leg raising result
  13. Any features of upper motor neuron lesion
  14. Gait abnormality not attributable to spinal pain
  15. Severe Central Spinal Canal Stenosis (> 50%) evident on prior computed tomogram or magnetic resonance image
  16. Spondylolysis
  17. Spondylolisthesis
  18. More than 75% narrowing of a disc space on plain radiographs
  19. Spondyloarthropathy
  20. Score higher than 20 on the Beck Depression Inventory
  21. Patients addicted to alcohol, narcotics or other illegal substances
  22. Dependence on opioids
  23. Uncontrolled acute/chronic illness that may confound interpretation of outcome measures
  24. Allergy to injectants, medication or anesthetics to be used
  25. Active or uncontrolled rheumatoid arthritis or other autoimmune diseases
  26. Patients with a history of mental instability or diagnosed with a mental disorder
  27. Patient unwilling or unable to comply with study procedures or follow-up visits
  28. The presence of a pacemaker in the patient
  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: NCT01590004

Contacts
Contact: Mehul J Desai, MD (301)588-7888 mehuljdesaimd@gmail.com
Contact: John D Genova, BA (301) 512-8301 johndgenova@gmail.com

Locations
United States, Maryland
Metro Orthopedics and Sports Therapy Recruiting
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
International Spine, Pain and Performance Center
Kimberly-Clark Corporation
Investigators
Principal Investigator: Mehul J Desai, MD International Spine, Pain and Performance Center
  More Information

No publications provided

Responsible Party: International Spine, Pain and Performance Center
ClinicalTrials.gov Identifier: NCT01590004     History of Changes
Other Study ID Numbers: lumbar01
Study First Received: April 30, 2012
Last Updated: January 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by International Spine, Pain and Performance Center:
LumbarCool system
Cooled radiofrequency medial ablation
Cooled-RF neurotomy

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014