Lumbar Facet Joint PainNCT01590004
Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain
An observational study of Lumbar Facet Joint Pain, run by Mehul Desai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Facet Joint Pain
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Mar 2016
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of Medical Advanced Pain Specialists, PA (MAPS)
Who may be able to join
- Literate
- Aged between 18 and 75 years
- Chronic lumbar pain for > 6 months
- 3-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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
- Spondylolysis
- Spondylolisthesis
- More than 75% narrowing of a disc space on plain radiographs
- Spondyloarthropathy
- Score higher than 20 on the Beck Depression Inventory
- Patients addicted to alcohol, narcotics or other illegal substances
- Dependence on opioids
- Uncontrolled acute/chronic illness that may confound interpretation of outcome measures
- Allergy to injectants, medication or anesthetics to be used
- Active or uncontrolled rheumatoid arthritis or other autoimmune diseases
- Patients with a history of mental instability or diagnosed with a mental disorder
- Patient unwilling or unable to comply with study procedures or follow-up visits
- The presence of a pacemaker in the patient
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MAPS Applied Research Center, Inc.
Edina, Minnesota, 55435
About this study
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.
Read the 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.
- Conditions
- Lumbar Facet Joint Pain
- Keywords
- LumbarCool system, Cooled radiofrequency medial ablation, Cooled-RF neurotomy
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 3 months post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Facet Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehul Desai
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Halyard Health
- Responsible party
- Sponsor-investigator, Mehul Desai, MAPS Applied Research Center
- Investigators
- Mehul J Desai, MD, Principal investigator, MAPS Applied Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590004
- Sponsor's protocol ID
- lumbar01
- Status last verified
- May 2015
- First submitted
- 30 Apr 2012
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain
- ClinicalTrials.gov ID
- NCT01590004
- Acronym / sponsor ID
- lumbar01
- Conditions
- Lumbar Facet Joint Pain
- Keywords
- LumbarCool system, Cooled radiofrequency medial ablation, Cooled-RF neurotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mehul DesaiIndustry (pharma, biotech, devices)
- Collaborators
- Halyard Health
- Study start
- Aug 2012
- Primary completion
- Mar 2016 (estimated)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Medical Advanced Pain Specialists, PA (MAPS)
Key inclusion criteria (11 listed)
- Literate
- Aged between 18 and 75 years
- Chronic lumbar pain for > 6 months
- 3-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)
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Confirm acute safety of the procedure
Time frame: Baseline to 3 months post 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
Related trials for Lumbar Facet Joint Pain
RecruitingObservational study
Prognostic Factors in Zygapophyseal Osteoarthritis Infiltration: a Prospective Cohort Study
Degenerative Arthropathy of Lumbar Spinal Facet Joint
RecruitingObservational study
Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration
Chronic Low Back Pain, Lumbar Facet Joint Degeneration
RecruitingObservational study
Long-Term Evaluation of the Performance and Safety of the IntraSPINE® Interlaminar Implant in the Treatment of Lumbar Degenerative Disc Disease
Lower Back Pain of Disc Origin, Joint Facet Syndrome
Recruiting
Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks
Pain, Chronic, Facet Joint Pain
Not yet recruiting
Lumbar Facet Platelet-Rich Plasma Injection Versus Medial Branch Radiofrequency Ablation for Chronic Lumbar Facet-Mediated Pain
Chronic Lower Back Pain (CLBP), Lumbar Facet Joint Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehul J Desai, MD principal investigator
MAPS Applied Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Facet Joint Pain, run by Mehul Desai at 1 site in United States.
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 11 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehul J Desai, MD ((301)588-7888, mehuljdesaimd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm acute safety of the procedure (time frame: Baseline to 3 months post procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2015.