- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02478437
A Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for theTreatment of Lumbar Facet Syndrome (STU00097239)
September 5, 2018 updated by: David Walega, Northwestern University
A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for the Treatment of Lumbar Facet Syndrome
This study is being done to determine whether cooled radiofrequency ablation (CRFA) on the medial branch nerves of the lumbar facet joint is effective for the treatment of low back pain.
CRFA blocks the nerves that carry pain signals from joints in the lower back such that the brain does not receive the message that the low back is in pain.
This technique is commonly performed by burning these nerves rather freezing them, but it is suspected that freezing them results in better pain relief.
The CRFA blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that CRFA will be effective when treating pain related to facet joints in the low back.
We are performing this study in order to determine if that is the case.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The CRFA blocks has been shown to effectively treat sacroiliac joint pain (a joint in the pelvis), which is another reason that it is suspected that CRFA will be effective when treating pain related to facet joints in the low back.
We are performing this study in order to determine if that is the case.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60611
- Anesthesiology Pain Managment Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with lumbar facet syndrome pain who would undergo treatment by lumbar medial branch radiofrequency ablation.
- Low back pain for at least 6 months.
- Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy or chiropractic care.
- Pain diagram suggesting possibility of facet-mediated pain.
- Referred pain when present not beyond the knee.
- Positive response to at least 1 set of diagnostic intra-articular facet injections or medial branch blocks, defined as > 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine).
Exclusion Criteria:
- Focal neurologic signs or symptoms.
- Radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis.
- Previous radiofrequency ablation treatment for similar symptoms.
- Patient refusal.
- Lack of consent.
- Active systemic or local infections at the site of proposed needle and electrode placement.
- Coagulopathy or other bleeding disorder, current use of anticoagulants or anti-platelet medications.
- Allergy to medications being used for injection procedures (contrast dye, local anesthetic, IV sedative).
- Inability to read English, communicate with staff, or participate in follow up.
- Pregnancy.
- Cognitive deficit.
- Negative response to diagnostic intra-articular facet injections or medial branch blocks, defined as < 75% reduction in pain following diagnostic blocks with local anesthetic (0.5mL of 0.5% bupivacaine OR 0.5 mL of 2% lidocaine).
- Daily opiate analgesic use more exceeding 3 months prior to study inclusion.
- Unstable medical or psychiatric illness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
Conventional radiofrequency ablation (RFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.
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A conventional RFA electrode with a 10mm active tip will be used.
RFA lesions will be performed for 90 seconds with the maximum electrode temperature raised to 80°C.
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Active Comparator: Group 2
Cooled radiofrequency ablation (CRFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia.
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Following 18G C-RFA electrode positioning, 1cc of 2% lidocaine will be injected through the introducer needle for anesthesia during the ablation.
The maximum electrode temperature is 60°C.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain improvement
Time Frame: 6 months post-procedure
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Percent of participants who reported 50% or greater improvement in pain
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6 months post-procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global pain score
Time Frame: 1 month, 3 months, 6 months and 12 months post procedure
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Global Numeric Rating Scale (NRS, 0 is no pain and 10 is worst pain imaginable)
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1 month, 3 months, 6 months and 12 months post procedure
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McGill Pain Questionnaire (MPQ)
Time Frame: 1 month, 3 months, 6 months and 12 months post procedure
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Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).
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1 month, 3 months, 6 months and 12 months post procedure
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Pain Anxiety Symptom Scale short form (PASS-20)
Time Frame: 1 month, 3 months, 6 months and 12 months post procedure
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The PASS-20 assesses 4 factorially distinct components of pain-related anxiety.
Each question is in a form of a 6-point Likert Scale anchored from 0 (never) to 5 (always).
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1 month, 3 months, 6 months and 12 months post procedure
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Center for Epidemiologic Studies Depression short form index (CESD-10)
Time Frame: 1 month, 3 months, 6 months and 12 months post procedure
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The possible range of the 10-item scale is 0 to 30, and a cut off score of ten or higher indicates the presence of significant depressive symptoms.
Subjects responded to each item of the scale by rating the frequency of each mood or symptom ''during the past week'' on a four-point scale.
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1 month, 3 months, 6 months and 12 months post procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
June 17, 2015
First Submitted That Met QC Criteria
June 18, 2015
First Posted (Estimate)
June 23, 2015
Study Record Updates
Last Update Posted (Actual)
September 6, 2018
Last Update Submitted That Met QC Criteria
September 5, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00097239
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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