Back PainPhase 4NCT03801356
Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
A Phase 4 study testing Selective Nerve Root Block in people with Back Pain and Radiculopathy Lumbar, run by The Cleveland Clinic at 1 site in United States.
Trial summary
SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Back Pain, Radiculopathy Lumbar, Degenerative Lumbar Spinal Stenosis
- What is being tested?
- Selective Nerve Root Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2018to 15 Dec 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-80
- Diagnosis of unilateral lower extremity radiculopathy due to degenerative foraminal stenosis
- Patients scheduled for an associated lumbar foraminotomy procedure
- Diagnosis of radiculopathy with imaging and/or clinical history or physical exam that does not demonstrate a clear neurogenic source of their pain
- Subjects must be available for the entire study duration (12 months)
Who cannot join
- Patients will be excluded if there is a clear correlation between imaging and radiculopathy
- Radiculopathy associated with trauma, tumor or infection. Non-radicular lower extremity pain will also be excluded
- Patients who cannot tolerate the SNRB without IV sedation
- Surgery requiring multi-level decompression and/or fusion
- Surgical indication for malignancy, injection or acute or emergency trauma
- History of major surgery within 3 months prior to enrollment
- Pregnant females
- Presence of severe acute, chronic medical or psychiatric condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defining the Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery. By using the walk test as an objective functional assessment, the aim is to better standardize the threshold for a positive response to SNRB.
In summary, SNRB, despite utilized frequently in the diagnostic work-up with patients with lumbar radiculopathy, vary widely in their sensitivity and specificity. The reasons, as outlined above, are multifactorial. The proposed study aims to minimize the known limitations of these injections and prospectively define their positive and negative predictive value in a homogenous group of patients undergoing surgery for lumbar foraminal stenosis and radiculopathy. The design will define a threshold of response utilizing both subjective and objective measures and more accurately predict excellent results following surgery.
Read the detailed description
The proposed study will identify the threshold response level that quantifies the predictive value of diagnostic SNRBs in patients who present with lumbar foraminal stenosis and radiculopathy. Specifically, the proposed study will address the question of whether there is a degree or length of response to SNRB, which predicts an excellent surgical outcome. The hypothesis is that diagnostic SNRBs, when performed correctly, are useful in localizing the level of involvement in LSS and improve the accuracy and efficacy of surgical intervention. Use of diagnostic SNRBs will thus be used to clarify the clinical picture, giving the surgeon the information to make the right decision to operate or not, and, in the case of operation, predicting the optimal level(s) for surgical intervention. In addition, the investigators plan to identify and fully characterize a standard threshold level and time of nerve block response that will optimize the accuracy, specificity, and sensitivity of SNRB in predicting surgical outcomes.
- Being tested
- Selective Nerve Root Block
- Keywords
- back pain, lumbar spine pain, nerve root block, foraminotomy, radiculopathy, lumbar, foraminal stenosis
- Medical subject headings
- Back Pain, Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Nerve Root BlockDrug
Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.
| Study group | Role | What they receive |
|---|---|---|
| Selective Nerve Root Block | Other | Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention. Receives: Drug: Selective Nerve Root Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Leg Pain Score
Aim: 0-2 point improvement
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark their pain level on the line between the two endpoints. The distance and change between '0' and the mark then defines the subject's pain. This will be measured at each subject visit.
Measured: 12-months
Secondary outcomes (3)
Oswestry Disability Index Questionnaire (ODI)
Aim: 15-point improvement
The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.
Structure / Content
There are 10 questions. The questions are designed in a way that to realize how the back or leg pain is affecting the patient's ability to manage in everyday life.
Scoring Method
Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The score can be multiplied by 2 to produce a percentage.
If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5
Interpretation
1.0%-20%: Minimal disability. Usually no treatment is indicated.
2.20%-40% Moderate disability
3.40%-60%: Severe disability
4.60%-80%: Crippled
5.80%-100%: These patients are either bed-bound or exaggerating their symptoms.
Measured: 12-Months
EQ-5D Questionnaire
Aim: Improvement in quality of life
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The questionnaire also records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: 12-Months
Pain Disability Questionnaire (PDQ)
Aim: 26-point improvement
The Pain Disability Questionnaire (PDQ) assesses perception of disability in relation to pain.
PDQ scores: mild/moderate (0-70), severe (71-100), and extreme (101-150).
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start23 Aug 2018
- Primary completion5 Nov 2020
- Study completion15 Dec 2020
Why it stopped: The study was terminated early due to a number of concurrent issues: low enrollment, limited data and COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be enrolled into a single treatment participant pool.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Lumbar Spine Research Society
- Responsible party
- Principal investigator, Michael Steinmetz, MD, The Cleveland Clinic
- Investigators
- Michael Steinmetz, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801356
- Sponsor's protocol ID
- 18-718
- Status last verified
- Jun 2023
- First submitted
- 9 Jan 2019
- Last updated
- 21 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
- ClinicalTrials.gov ID
- NCT03801356
- Acronym / sponsor ID
- 18-718
- Keywords
- back pain, lumbar spine pain, nerve root block, foraminotomy, radiculopathy, lumbar, foraminal stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early due to a number of concurrent issues: low enrollment, limited data and COVID-19.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Lumbar Spine Research Society
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Posted 21 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery. By using the walk test as an objective functional assessment, the aim is to better standardize the threshold for a positive response to SNRB.
In summary, SNRB, despite utilized frequently in the diagnostic work-up with patients with lumbar radiculopathy, vary widely in their sensitivity and specificity. The reasons, as outlined above, are multifactorial. The proposed study aims to minimize the known limitations of these injections and prospectively define their positive and negative predictive value in a homogenous group of patients undergoing surgery for lumbar foraminal stenosis and radiculopathy. The design will define a threshold of response utilizing both subjective and objective measures and more accurately predict excellent results following surgery.
Detailed description
The proposed study will identify the threshold response level that quantifies the predictive value of diagnostic SNRBs in patients who present with lumbar foraminal stenosis and radiculopathy. Specifically, the proposed study will address the question of whether there is a degree or length of response to SNRB, which predicts an excellent surgical outcome. The hypothesis is that diagnostic SNRBs, when performed correctly, are useful in localizing the level of involvement in LSS and improve the accuracy and efficacy of surgical intervention. Use of diagnostic SNRBs will thus be used to clarify the clinical picture, giving the surgeon the information to make the right decision to operate or not, and, in the case of operation, predicting the optimal level(s) for surgical intervention. In addition, the investigators plan to identify and fully characterize a standard threshold level and time of nerve block response that will optimize the accuracy, specificity, and sensitivity of SNRB in predicting surgical outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be enrolled into a single treatment participant pool.
| Arm | Type | Receives |
|---|---|---|
| Selective Nerve Root Block | Other | Drug: Selective Nerve Root BlockPatient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 18-80
- Diagnosis of unilateral lower extremity radiculopathy due to degenerative foraminal stenosis
- Patients scheduled for an associated lumbar foraminotomy procedure
- Diagnosis of radiculopathy with imaging and/or clinical history or physical exam that does not demonstrate a clear neurogenic source of their pain
- Subjects must be available for the entire study duration (12 months)
Key exclusion criteria (8 listed)
- Patients will be excluded if there is a clear correlation between imaging and radiculopathy
- Radiculopathy associated with trauma, tumor or infection. Non-radicular lower extremity pain will also be excluded
- Patients who cannot tolerate the SNRB without IV sedation
- Surgery requiring multi-level decompression and/or fusion
- Surgical indication for malignancy, injection or acute or emergency trauma
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 |
|---|---|---|
| Selective Nerve Root BlockPrior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy. | Drug | Selective Nerve Root Block |
Primary outcome
Visual Analog Scale (VAS) Leg Pain Score
Time frame: 12-months
Aim: 0-2 point improvement The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark their pain level on the line between the two endpoints. The distance and change between '0' and the mark then defines the subject's pain. This will be measured at each subject visit.
3 secondary outcomes
Oswestry Disability Index Questionnaire (ODI)
Time frame: 12-Months
EQ-5D Questionnaire
Time frame: 12-Months
Pain Disability Questionnaire (PDQ)
Time frame: 12-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Michael Steinmetz, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selective Nerve Root Block in people with Back Pain and Radiculopathy Lumbar, run by The Cleveland Clinic 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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 21 Jul 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Scale (VAS) Leg Pain Score (time frame: 12-months). 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 21 Jul 2023.