Low Back PainPhase 3STU00097239NCT02478437
A Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for theTreatment of Lumbar Facet Syndrome
A Phase 3 study testing Conventional radiofrequency ablation (RFA) and Cooled Radiofrequency Ablation (CRFA) in people with Low Back Pain, run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Conventional radiofrequency ablation (RFA) and Cooled Radiofrequency Ablation (CRFA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2018
- Phase
- Phase 3
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anesthesiology Pain Managment Center
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Conventional radiofrequency ablation (RFA), Cooled Radiofrequency Ablation (CRFA)
- Keywords
- Lumbar Facet Syndrome
- 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.
Conventional radiofrequency ablation (RFA)Procedure or surgery
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.
Cooled Radiofrequency Ablation (CRFA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Conventional radiofrequency ablation (RFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia. Receives: Procedure: Conventional radiofrequency ablation (RFA) |
| Group 2 | Active comparator | Cooled radiofrequency ablation (CRFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia. Receives: Procedure: Cooled Radiofrequency Ablation (CRFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain improvement
Percent of participants who reported 50% or greater improvement in pain
Measured: 6 months post-procedure
Secondary outcomes (4)
Global pain score
Global Numeric Rating Scale (NRS, 0 is no pain and 10 is worst pain imaginable)
Measured: 1 month, 3 months, 6 months and 12 months post procedure
McGill Pain Questionnaire (MPQ)
Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain).
Measured: 1 month, 3 months, 6 months and 12 months post procedure
Pain Anxiety Symptom Scale short form (PASS-20)
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).
Measured: 1 month, 3 months, 6 months and 12 months post procedure
Center for Epidemiologic Studies Depression short form index (CESD-10)
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.
Measured: 1 month, 3 months, 6 months and 12 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 posted23 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Pain Society
- Responsible party
- Principal investigator, David Walega, Northwestern University
- Investigators
- David Walega, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478437
- Sponsor's protocol ID
- STU00097239
- Acronym
- STU00097239
- Status last verified
- Sep 2018
- First submitted
- 17 Jun 2015
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McCormick ZL, Choi H, Reddy R, Syed RH, Bhave M, Kendall MC, Khan D, Nagpal G, Teramoto M, Walega DR. Randomized prospective trial of cooled versus traditional radiofrequency ablation of the medial branch nerves for the treatment of lumbar facet joint pain. Reg Anesth Pain Med. 2019 Mar;44(3):389-397. doi: 10.1136/rapm-2018-000035.
PubMed 30777903
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves for the Treatment of Lumbar Facet Syndrome
- ClinicalTrials.gov ID
- NCT02478437
- Acronym / sponsor ID
- STU00097239 / STU00097239
- Conditions
- Low Back Pain
- Keywords
- Lumbar Facet Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Pain Society
- Study start
- Jun 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 23 Jun 2015 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Conventional radiofrequency ablation (RFA)Conventional radiofrequency ablation (RFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia. |
| Group 2 | Active comparator | Procedure: Cooled Radiofrequency Ablation (CRFA)Cooled radiofrequency ablation (CRFA) Following ablation, 0.5 cc of 0.5% bupivacaine will be injected to provide post procedure analgesia. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional radiofrequency ablation (RFA)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. | Procedure or surgery | Group 1 |
| Cooled Radiofrequency Ablation (CRFA)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. | Procedure or surgery | Group 2 |
Primary outcome
Pain improvement
Time frame: 6 months post-procedure
Percent of participants who reported 50% or greater improvement in pain
4 secondary outcomes
Global pain score
Time frame: 1 month, 3 months, 6 months and 12 months post procedure
McGill Pain Questionnaire (MPQ)
Time frame: 1 month, 3 months, 6 months and 12 months post procedure
Pain Anxiety Symptom Scale short form (PASS-20)
Time frame: 1 month, 3 months, 6 months and 12 months post procedure
Center for Epidemiologic Studies Depression short form index (CESD-10)
Time frame: 1 month, 3 months, 6 months and 12 months post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Derived from this study: PubMed 30777903McCormick ZL, Choi H, Reddy R, Syed RH, Bhave M, Kendall MC, Khan D, Nagpal G, Teramoto M, Walega DR. Randomized prospective trial of cooled versus traditional radiofrequency ablation of the medial branch nerves for the treatment of lumbar facet joint pain. Reg Anesth Pain Med. 2019 Mar;44(3):389-397. doi: 10.1136/rapm-2018-000035.
- Individual participant dataSharing planned: No
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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.
David Walega, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional radiofrequency ablation (RFA) and Cooled Radiofrequency Ablation (CRFA) in people with Low Back Pain, run by Northwestern University 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 6 inclusion and 14 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 6 Sep 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain improvement (time frame: 6 months post-procedure). 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 NCT02478437, which also lists 1 linked publication.
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 6 Sep 2018.