Lumbar Facet Joint PainNCT02002429
Medial Branch Blocks vs. Intra-articular Injections: Randomized, Controlled Study
A study testing Intra-articular injection, Medial branch block and Saline injection in people with Lumbar Facet Joint Pain and Low Back Pain, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Background: Facet interventions are the second most commonly performed procedure in pain clinics throughout the U.S, including in the military. Currently, there is no clear consensus regarding whether intra-articular (IA) blocks or medial branch blocks (facet joint nerve; MBB) are the best way to diagnose and treat… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Facet Joint Pain, Low Back Pain
- What is being tested?
- Intra-articular injection, Medial branch block and Saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Aug 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Suspected lumbar facet arthropathy based on history and physical exam (e.g. axial lower back pain, paraspinal tenderness, no pain referral below the knee)
- NRS back pain score > 4;
- MRI evidence of spinal pathology consistent with symptoms.
Who cannot join
- Untreated coagulopathy
- No MRI study
- Signs or symptoms of cauda equina syndrome
- Focal neurological signs and symptoms
- Allergic reactions to local anesthetics or contrast dye
- Serious medical or condition that might preclude optimal outcome
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Medial Branch Blocks vs. Intra-articular Injections: Randomized, Controlled Study Comparing Lumbar Facet Radiofrequency Denervation Using Diagnostic Injections.
Background: Facet interventions are the second most commonly performed procedure in pain clinics throughout the U.S, including in the military. Currently, there is no clear consensus regarding whether intra-articular (IA) blocks or medial branch blocks (facet joint nerve; MBB) are the best way to diagnose and treat facetogenic pain, or even whether or not to perform diagnostic/ prognostic blocks.
Hypothesis: IA blocks will provide better relief than MBB, but MBB may better select patients for radiofrequency denervation.
Read more
Purpose: Objective 1: Determine which "prognostic" block is the best predictor for RF denervation outcome; Objective 2: To determine whether adding steroids to IA or MBB may provide intermediate or long-term benefit to a subset of individuals.
Research Design: Randomized, comparative-effectiveness study
Methodology /Technical Approach: A total of 225 patients with non-radicular chronic low back pain (LBP) with suspected facetogenic etiology will be randomized in a 2:2:1 ratio to one of 3 groups:
Group 1 will receive IA blocks with steroids and LA Group 2 will receive MBB with steroids and LA Group 3 will receive MBB with only saline
Those individuals who obtain significant (≥ 50% in groups 1 and 2,3) but temporary (< 1-month) relief will undergo radiofrequency (RF) denervation at their 1-month follow-up. In group 3, those patients who do not experience pain relief at 1-month will undergo RF denervation regardless of the pain relief they experience (as many practitioners in the military and civilian practices do without diagnostic blocks).1-3 Participants in Groups 1 and 2 who experience prolonged relief from their diagnostic/ therapeutic blocks with LA and steroids will not undergo RF denervation until their pain returns. Those individuals who experience prolonged relief lasting > 6 months will be given the option of repeating the diagnostic/ therapeutic block. In Groups 1, 2 and 3 patients who experience prolonged relief from the diagnostic blocks, follow-up visits will be at 1-month, 3-months and 6-months after the block, or until their pain relief wears off. In those who undergo denervation based on a positive block, follow-ups will be performed 1, 3 and 6-months after the denervation provided they continue to experience significant (> 50%) relief at each follow-up. Those individuals who fail to experience significant relief after denervation will be unblinded and exit the study per protocol.
Read the detailed description
Two hundred and twenty five patients with suspected lumbar facet arthropathy scheduled to undergo diagnostic lumbar facet blocks will be enrolled in this study at WRNMMC and randomized in a 2:2:1 ratio into one of 3 groups. Group 1 will receive IA blocks with steroids and LA, group 2 will receive MBB with steroids and LA, and group 3 will receive MBB with only saline. Subjects and (but not injecting physicians) evaluators will be blinded throughout their participation in the study as to treatment allocation. The nerves and joints to be blocked will be determined by physical exam (i.e. the location of paraspinal tenderness), and radiological findings.
Group 1: The 80 patients in this group will undergo IA blocks under fluoroscopic guidance with 0.5 mL solutions containing a 50:50 mixture of 0.5% bupivacaine and 10 mg depomethylprednisolone (called "steroid"). In all cases, correct positioning will be confirmed by the administration of contrast. After the block, they will be administered a pain diary to maintain for the next 6 hours. In accordance with standard care, a positive response will be > 50% pain relief lasting at least 3 hours. Patients who have not undergone physical therapy (PT) will be sent for PT . The first follow-up will be at 1-month. In those individuals with a positive block whose pain has returned to baseline, RF denervation will be performed at the same levels done for the diagnostic block. Once adequate sensory stimulation is confirmed, a 1 mL mixture containing equal amounts of 2% lidocaine 0.5 mL) and 20 mg depo-methylprednisolone (0.5 mL) will be injected to reduce procedure-related pain and decrease the incidence of neuritis. For those patients who have persistent (> 50%) pain relief at 1-month, they will return for their 2nd follow-up at 3-months. If their pain relief persists at this point, their final follow-up will be 6-months post-procedure. Pain relief in this group that lasts > 6 months can be treated with repeat IA injections if the patient so desires, while that which persists for < 6 months will be treated with RF denervation. Patients who experience a negative diagnostic block, or who fail to obtain significant pain relief at any follow-up from their RF denervation, will exit the study per protocol to pursue alternative treatments
Group 2: The 80 patients in this group will undergo MBB blocks under fluoroscopic guidance with 0.5 mL solutions containing a 50:50 mixture of 0.5% bupivacaine and 10 mg of depo-methylprednisolone steroid. After the block, they will be administered a pain diary to maintain for the next 6 hours. Patients who have not undergone physical therapy will be sent for a PT program. The first follow-up will be at 1-month. In those individuals who do not experience significant pain relief, RF denervation will be performed at the same levels done for the diagnostic block, as described in 'Group 1'. For those patients who have persistent (> 50%) pain relief at 1-month, they will return for their 2nd follow-up at 3-months. If their pain relief persists at this point, their final follow-up will be 6-months post-procedure. Pain relief in this group that lasts > 6 months can be treated with repeat MBB if they desire, while that which persists for < 6 months will be treated with RF denervation. Patients who experience a negative diagnostic block, or who fail to obtain significant pain relief at any follow-up from their RF denervation, will exit the study per protocol to pursue alternative treatments.
Group 3: The 40 patients in this group will undergo IA blocks under fluoroscopic guidance with 0.5 mL of normal saline. After the block, they will be administered a pain diary to maintain for the next 6 hours. Patients who have not undergone physical therapy will be sent for PT. The first follow-up will be at 1-month. In those individuals who fail to experience significant pain relief at this time point, RF denervation will be performed at the same levels done for the diagnostic block, as described in 'Group 1'. For those patients who have persistent (> 50%) pain relief at 1-month, they will return for their 2nd follow-up at 3-months. If their pain relief persists at this point, their final follow-up will be 6-months post-procedure. Pain relief from the block in this group that lasts > 6 months can be treated with repeat MBB, while that which persists for < 6 months will be treated with RF denervation. In patients who do not experience significant pain relief at their 1-month follow-up, RF denervation will be performed. Those who experience a negative outcome from RF denervation, will exit the study per protocol to pursue alternative treatments.
During follow visits, subjects who have difficulty arranging for transportation can elect to conduct their follow-up visits over the telephone, via fax, or by e-mail, whichever is most convenient.
- Conditions
- Lumbar Facet Joint Pain, Low Back Pain
- Being tested
- Intra-articular injection, Medial branch block, Saline injection
- Keywords
- Facet joint, Medial branch block, Radiofrequency denervation, Zygapophysial joint, Low back pain
- 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.
Intra-articular injectionProcedure or surgery
Intra-articular injection into the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine. If the subject has a positive block a radiofrequency denervation will be performed at the affected joint.
Medial branch blockProcedure or surgery
Medial branch blocks at the nerves that supply the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine. If the subject has a positive block a radiofrequency denervation will be performed at the affected joint.
Saline injectionProcedure or surgery
Injection into the affected facet joint(s) with 0.5 ml of normal saline. All subjects in the group will receive radiofrequency denervation.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular injection | Experimental | Intra-articular injection into the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine Receives: Procedure: Intra-articular injection |
| Medial branch block | Active comparator | Medial branch blocks at the nerves that supply the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine Receives: Procedure: Medial branch block |
| Saline injection | Sham comparator | Injection into the affected facet joint(s) with 0.5 ml of normal saline Receives: Procedure: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
0-10 numerical rating scale (NRS) average pain score after facet injection
Measured: 1 month
Pain Score
0-10 numerical rating scale pain score after radiofrequency ablation
Measured: 3 months
Secondary outcomes (29)
Successful outcome after RF denervation
Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3
Measured: 1 month
Successful outcome after RF denervation
Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3
Measured: 3 months
Successful outcome after RF denervation
Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3
Measured: 6 months
Successful outcome after facet block
Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3
Measured: 1 month
Successful outcome after facet block
Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3
Measured: 3 months
Successful outcome after facet block
Proportion of patients in each arm who undergo RF denervation who experience a > 50% decrease in pain score and a satisfaction score > 3
Measured: 6 months
Proportion of people with a positive pain diary
Proportion of people who experience > 50% pain relief after the diagnostic block
Measured: 1-day after injection
Pain score
Worst NRS pain score 1 month after initial injection
Measured: 1 month
Pain score
Average NRS pain score 3 months after initial injection
Measured: 3 months
Pain score
Worst NRS pain score 3 months after initial injection
Measured: 3 months
Pain score
Average NRS pain score 6 months after initial injection
Measured: 6 months
Pain score
Worst NRS pain score 6 months after initial injection
Measured: 6 months
Pain score
Average NRS pain score 1 month after RF denervation
Measured: 1 month
Pain score
Worst NRS pain score 1 month after RF denervation
Measured: 1 month
Pain score
Worst NRS pain score 3 months after RF denervation
Measured: 3 months
Pain score
Average NRS pain score 6 months after RF denervation
Measured: 6 months
Pain score
Worst NRS pain score 6 months after RF denervation
Measured: 6 months
Function
Oswestry disability index score 1-month after initial injection
Measured: 1 month
Function
Oswestry disability score 3-months after initial injection
Measured: 3 months
Function
Oswestry disability score 6-months after initial injection
Measured: 3 months
Function
Oswestry disability score 1-month after RF denervation
Measured: 1 month
Function
Oswestry disability score 3-months after RF denervation
Measured: 3 months
Function
Oswestry disability score 6-months after RF denervation
Measured: 6 months
Satisfaction
Satisfaction on 1-5 scale 1-month after initial injection
Measured: 1-month
Satisfaction
Satisfaction on 1-5 scale 3-months after initial injection
Measured: 3-months
Satisfaction
Satisfaction on 1-5 scale 6-months after initial injection
Measured: 6-months
Satisfaction
Satisfaction on 1-5 scale 1-month after RF denervation
Measured: 1-month
Satisfaction
Satisfaction on 1-5 scale 3-months after RF denervation
Measured: 3-months
Satisfaction
Satisfaction on 1-5 scale 6-months after RF denervation
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Facet Joint PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center
- Responsible party
- Sponsor
- Investigators
- Steven P Cohen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002429
- Sponsor's protocol ID
- NA_00086597
- Status last verified
- Jan 2018
- First submitted
- 1 Dec 2013
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cohen SP, Huang JH, Brummett C. Facet joint pain--advances in patient selection and treatment. Nat Rev Rheumatol. 2013 Feb;9(2):101-16. doi: 10.1038/nrrheum.2012.198. Epub 2012 Nov 20.
PubMed 23165358Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024.
PubMed 17325518Cohen SP, Doshi TL, Constantinescu OC, Zhao Z, Kurihara C, Larkin TM, Griffith SR, Jacobs MB, Kroski WJ, Dawson TC, Fowler IM, White RL, Verdun AJ, Jamison DE, Anderson-White M, Shank SE, Pasquina PF. Effectiveness of Lumbar Facet Joint Blocks and Predictive Value before Radiofrequency Denervation: The Facet Treatment Study (FACTS), a Randomized, Controlled Clinical Trial. Anesthesiology. 2018 Sep;129(3):517-535. doi: 10.1097/ALN.0000000000002274.
PubMed 29847426
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Branch Blocks vs. Intra-articular Injections: Randomized, Controlled Study Comparing Lumbar Facet Radiofrequency Denervation Using Diagnostic Injections.
- ClinicalTrials.gov ID
- NCT02002429
- Acronym / sponsor ID
- NA_00086597
- Conditions
- Lumbar Facet Joint Pain, Low Back Pain
- Keywords
- Facet joint, Medial branch block, Radiofrequency denervation, Zygapophysial joint, Low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center
- Study start
- Mar 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 5 Dec 2013 (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.
Background: Facet interventions are the second most commonly performed procedure in pain clinics throughout the U.S, including in the military. Currently, there is no clear consensus regarding whether intra-articular (IA) blocks or medial branch blocks (facet joint nerve; MBB) are the best way to diagnose and treat facetogenic pain, or even whether or not to perform diagnostic/ prognostic blocks.
Hypothesis: IA blocks will provide better relief than MBB, but MBB may better select patients for radiofrequency denervation.
Purpose: Objective 1: Determine which "prognostic" block is the best predictor for RF denervation outcome; Objective 2: To determine whether adding steroids to IA or MBB may provide intermediate or long-term benefit to a subset of individuals.
Research Design: Randomized, comparative-effectiveness study
Methodology /Technical Approach: A total of 225 patients with non-radicular chronic low back pain (LBP) with suspected facetogenic etiology will be randomized in a 2:2:1 ratio to one of 3 groups:
Group 1 will receive IA blocks with steroids and LA Group 2 will receive MBB with steroids and LA Group 3 will receive MBB with only saline
Those individuals who obtain significant (≥ 50% in groups 1 and 2,3) but temporary (< 1-month) relief will undergo radiofrequency (RF) denervation at their 1-month follow-up. In group 3, those patients who do not experience pain relief at 1-month will undergo RF denervation regardless of the pain relief they experience (as many practitioners in the military and civilian practices do without diagnostic blocks).1-3 Participants in Groups 1 and 2 who experience prolonged relief from their diagnostic/ therapeutic blocks with LA and steroids will not undergo RF denervation until their pain returns. Those individuals who experience prolonged relief lasting > 6 months will be given the option of repeating the diagnostic/ therapeutic block. In Groups 1, 2 and 3 patients who experience prolonged relief from the diagnostic blocks, follow-up visits will be at 1-month, 3-months and 6-months after the block, or until their pain relief wears off. In those who undergo denervation based on a positive block, follow-ups will be performed 1, 3 and 6-months after the denervation provided they continue to experience significant (> 50%) relief at each follow-up. Those individuals who fail to experience significant relief after denervation will be unblinded and exit the study per protocol.
Detailed description
Two hundred and twenty five patients with suspected lumbar facet arthropathy scheduled to undergo diagnostic lumbar facet blocks will be enrolled in this study at WRNMMC and randomized in a 2:2:1 ratio into one of 3 groups. Group 1 will receive IA blocks with steroids and LA, group 2 will receive MBB with steroids and LA, and group 3 will receive MBB with only saline. Subjects and (but not injecting physicians) evaluators will be blinded throughout their participation in the study as to treatment allocation. The nerves and joints to be blocked will be determined by physical exam (i.e. the location of paraspinal tenderness), and radiological findings.
Group 1: The 80 patients in this group will undergo IA blocks under fluoroscopic guidance with 0.5 mL solutions containing a 50:50 mixture of 0.5% bupivacaine and 10 mg depomethylprednisolone (called "steroid"). In all cases, correct positioning will be confirmed by the administration of contrast. After the block, they will be administered a pain diary to maintain for the next 6 hours. In accordance with standard care, a positive response will be > 50% pain relief lasting at least 3 hours. Patients who have not undergone physical therapy (PT) will be sent for PT . The first follow-up will be at 1-month. In those individuals with a positive block whose pain has returned to baseline, RF denervation will be performed at the same levels done for the diagnostic block. Once adequate sensory stimulation is confirmed, a 1 mL mixture containing equal amounts of 2% lidocaine 0.5 mL) and 20 mg depo-methylprednisolone (0.5 mL) will be injected to reduce procedure-related pain and decrease the incidence of neuritis. For those patients who have persistent (> 50%) pain relief at 1-month, they will return for their 2nd follow-up at 3-months. If their pain relief persists at this point, their final follow-up will be 6-months post-procedure. Pain relief in this group that lasts > 6 months can be treated with repeat IA injections if the patient so desires, while that which persists for < 6 months will be treated with RF denervation. Patients who experience a negative diagnostic block, or who fail to obtain significant pain relief at any follow-up from their RF denervation, will exit the study per protocol to pursue alternative treatments
Group 2: The 80 patients in this group will undergo MBB blocks under fluoroscopic guidance with 0.5 mL solutions containing a 50:50 mixture of 0.5% bupivacaine and 10 mg of depo-methylprednisolone steroid. After the block, they will be administered a pain diary to maintain for the next 6 hours. Patients who have not undergone physical therapy will be sent for a PT program. The first follow-up will be at 1-month. In those individuals who do not experience significant pain relief, RF denervation will be performed at the same levels done for the diagnostic block, as described in 'Group 1'. For those patients who have persistent (> 50%) pain relief at 1-month, they will return for their 2nd follow-up at 3-months. If their pain relief persists at this point, their final follow-up will be 6-months post-procedure. Pain relief in this group that lasts > 6 months can be treated with repeat MBB if they desire, while that which persists for < 6 months will be treated with RF denervation. Patients who experience a negative diagnostic block, or who fail to obtain significant pain relief at any follow-up from their RF denervation, will exit the study per protocol to pursue alternative treatments.
Group 3: The 40 patients in this group will undergo IA blocks under fluoroscopic guidance with 0.5 mL of normal saline. After the block, they will be administered a pain diary to maintain for the next 6 hours. Patients who have not undergone physical therapy will be sent for PT. The first follow-up will be at 1-month. In those individuals who fail to experience significant pain relief at this time point, RF denervation will be performed at the same levels done for the diagnostic block, as described in 'Group 1'. For those patients who have persistent (> 50%) pain relief at 1-month, they will return for their 2nd follow-up at 3-months. If their pain relief persists at this point, their final follow-up will be 6-months post-procedure. Pain relief from the block in this group that lasts > 6 months can be treated with repeat MBB, while that which persists for < 6 months will be treated with RF denervation. In patients who do not experience significant pain relief at their 1-month follow-up, RF denervation will be performed. Those who experience a negative outcome from RF denervation, will exit the study per protocol to pursue alternative treatments.
During follow visits, subjects who have difficulty arranging for transportation can elect to conduct their follow-up visits over the telephone, via fax, or by e-mail, whichever is most convenient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intra-articular injection | Experimental | Procedure: Intra-articular injectionIntra-articular injection into the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine |
| Medial branch block | Active comparator | Procedure: Medial branch blockMedial branch blocks at the nerves that supply the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine |
| Saline injection | Sham comparator | Procedure: Saline injectionInjection into the affected facet joint(s) with 0.5 ml of normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Suspected lumbar facet arthropathy based on history and physical exam (e.g. axial lower back pain, paraspinal tenderness, no pain referral below the knee)
- NRS back pain score > 4;
- MRI evidence of spinal pathology consistent with symptoms.
Key exclusion criteria (7 listed)
- Untreated coagulopathy
- No MRI study
- Signs or symptoms of cauda equina syndrome
- Focal neurological signs and symptoms
- Allergic reactions to local anesthetics or contrast dye
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 |
|---|---|---|
| Intra-articular injectionIntra-articular injection into the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine. If the subject has a positive block a radiofrequency denervation will be performed at the affected joint. | Procedure or surgery | Intra-articular injection |
| Medial branch blockMedial branch blocks at the nerves that supply the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine. If the subject has a positive block a radiofrequency denervation will be performed at the affected joint. | Procedure or surgery | Medial branch block |
| Saline injectionInjection into the affected facet joint(s) with 0.5 ml of normal saline. All subjects in the group will receive radiofrequency denervation. | Procedure or surgery | Saline injection |
Primary outcome
Pain Score
Time frame: 1 month
0-10 numerical rating scale (NRS) average pain score after facet injection
Pain Score
Time frame: 3 months
0-10 numerical rating scale pain score after radiofrequency ablation
29 secondary outcomes
Successful outcome after RF denervation
Time frame: 1 month
Successful outcome after RF denervation
Time frame: 3 months
Successful outcome after RF denervation
Time frame: 6 months
Successful outcome after facet block
Time frame: 1 month
Successful outcome after facet block
Time frame: 3 months
Successful outcome after facet block
Time frame: 6 months
Proportion of people with a positive pain diary
Time frame: 1-day after injection
Pain score
Time frame: 1 month
Pain score
Time frame: 3 months
Pain score
Time frame: 3 months
Pain score
Time frame: 6 months
Pain score
Time frame: 6 months
Pain score
Time frame: 1 month
Pain score
Time frame: 1 month
Pain score
Time frame: 3 months
Pain score
Time frame: 6 months
Pain score
Time frame: 6 months
Function
Time frame: 1 month
Function
Time frame: 3 months
Function
Time frame: 3 months
Function
Time frame: 1 month
Function
Time frame: 3 months
Function
Time frame: 6 months
Satisfaction
Time frame: 1-month
Satisfaction
Time frame: 3-months
Satisfaction
Time frame: 6-months
Satisfaction
Time frame: 1-month
Satisfaction
Time frame: 3-months
Satisfaction
Time frame: 6-months
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 12 Jan 2018.
- Background: PubMed 23165358Cohen SP, Huang JH, Brummett C. Facet joint pain--advances in patient selection and treatment. Nat Rev Rheumatol. 2013 Feb;9(2):101-16. doi: 10.1038/nrrheum.2012.198. Epub 2012 Nov 20.
- Background: PubMed 17325518Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024.
- Derived from this study: PubMed 29847426Cohen SP, Doshi TL, Constantinescu OC, Zhao Z, Kurihara C, Larkin TM, Griffith SR, Jacobs MB, Kroski WJ, Dawson TC, Fowler IM, White RL, Verdun AJ, Jamison DE, Anderson-White M, Shank SE, Pasquina PF. Effectiveness of Lumbar Facet Joint Blocks and Predictive Value before Radiofrequency Denervation: The Facet Treatment Study (FACTS), a Randomized, Controlled Clinical Trial. Anesthesiology. 2018 Sep;129(3):517-535. doi: 10.1097/ALN.0000000000002274.
- 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.
Steven P Cohen, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular injection, Medial branch block and Saline injection in people with Lumbar Facet Joint Pain and Low Back Pain, run by Johns Hopkins University at 2 sites 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 4 inclusion and 7 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 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
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 Score (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT02002429, which also lists 3 linked publications.
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 12 Jan 2018.