Spinal Stenosis, Lumbar Region, With Neurogenic ClaudicationNCT01995461
Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis
A study testing bilateral transforaminal epidural steroid injections in people with Spinal Stenosis, Lumbar Region, With Neurogenic Claudication, run by Marshfield Clinic Research Foundation at 1 site in United States.
Trial summary
The most common forms of injection used for the treatment of degenerative lumbar spinal stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar epidural injections of anesthetic and steroid. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
- What is being tested?
- bilateral transforaminal epidural steroid injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2014
- Phase
- Interventional
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of back/buttock/leg pain (NOT radicular pain) in a neurogenic claudicatory fashion, relieved by stooping or sitting down, for at least 3 months with no or poor response to conservative treatment (analgesics, NSAIDs, or physical therapy)
- Patients with bilateral buttock and/or bilateral lower extremity pain in a neurogenic fashion with or without lower back pain
- Radiologic documentation of degree of degenerative lumbar spinal stenosis (DLSS)
- MRI/CT showing at least moderate central canal spinal stenosis (neuro-radiologist definition) with symptoms correlating with stenosis (symptoms of back/buttock/leg pain without unilateral radicular pain in a neurogenic claudicatory fashion, relieved by stooping or sitting down)
- Patients choosing to receive BTESI as their next treatment option, following discussions with their spine doctor
- Patients who can give informed consent, could tolerate the procedure, and who are able to understand and answer the forms and questionnaires properly.
Who cannot join
- Radiologic spinal stenosis without symptoms of spinal stenosis
- Symptoms of neurogenic claudication without at least moderate degree of radiologic spinal stenosis
- Patients with specific lumbo-sacral radicular symptoms or radiculopathy (radicular pain secondary to a single nerve root compression/inflammation; usually follows a specific dermatome in lower extremities; unilateral radiculopathy either from disc herniation or lateral recess stenosis)
- Patients with vascular claudication (pain in the legs secondary to arterial insufficiency)
- Previous lumbo-sacral surgery
- Any condition that does not allow the patient to stand and/or walk for any length of time (e.g., COPD, severe lung disease, etc.)
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- Patients with symptomatic hip joint pathology concurrent with spinal stenosis
- A coexisting musculoskeletal condition that would negate functional improvement from the injection (e.g., severe Parkinson disease, hemiparesis, etc.)
- Malignancy or infection to the spine
- Another pain generating condition that would mask the improvement provided by the injection
- Patients who had lumbar epidural steroid injections within the past six months
- Significant psychologic diagnosis and/or dementia
- Patients receiving workman's compensation benefit
- Patients unable to give consent on their own, or who are not able to understand and answer the forms and questionnaires, or their answers will not be reliable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Bilateral Transforaminal Epidural Steroid Injections in Degenerative Lumbar Spinal Stenosis Patients With Neurogenic Claudication: A Prospective Outcome Study
The most common forms of injection used for the treatment of degenerative lumbar spinal stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar epidural injections of anesthetic and steroid. Unilateral transforaminal epidural steroid injections (TESI) are also used to alleviate patients' symptoms of NC from DLSS, particularly in patients whose level of stenosis is L4-5 or higher. However, these unilateral injections do not cross the midline, so in cases of lower extremity pain and symptoms on both sides, a bilateral TESI would probably be more beneficial.
To date, there have not been any well designed prospective studies to determine the effectiveness of bilateral TESI below the level of stenosis in DLSS patients with NC. Therefore, the goal of this prospective, non-randomized case-series outcome study is to evaluate the effectiveness of BTESI in alleviating symptoms of NC, as well as improving function in patients with DLSS. The hypothesis is that BTESI at the level below the most stenotic segment of the central canal of the lumbar spine decreases symptoms of NC and improves function in patients with DLSS.
- Being tested
- bilateral transforaminal epidural steroid injections
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral transforaminal epidural steroid injectionsDrug
Also called BTESI
BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection.
| Study group | Role | What they receive |
|---|---|---|
| BTESI | Experimental | a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI) Receives: Drug: bilateral transforaminal epidural steroid injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Pain Score at 6 Months
change from baseline (pre-1st injection) pain score, based on a numeric pain scale of 0-10(most severe pain), at 6 months post-1st injection
Measured: baseline (pre-1st injection) to 6 months post-1st injection
Secondary outcomes (2)
Change From Baseline Swiss Spinal Stenosis Score at 6 Months
The Swiss spinal stenosis score is a questionnaire composed of 18 multiple choice questions designed to give information as to how the patient's back and leg pain is affecting their ability to manage everyday life. The Swiss spinal stenosis (SSS) questionnaire consists of 12 baseline questions asked of all participants prior to injection and an additional 6 questions asked at each time point post-treatment. The initial 12 questions assess reliability and condition at baseline while the 6 post-treatment questions assess treatment satisfaction. All questions ask the patient to assess symptoms over the previous month with a total maximum score for the initial 12 questions of 53 and a total maximum score of 24 for the 6 additional questions. The final total score is expressed as a percentage of the maximum possible score. Total score increases with worsening disability.
Measured: baseline (pre-1st injection) to 6 months post-1st injection
Change From Baseline Oswestry Disability Index at 6 Months
The 2 questions from this Index pertaining to Standing and Walking are being utilized to assess changes in duration of standing and walking in these patients. The two sections of the Oswestry Disability Index (ODI) used in the present study were those related to walking and standing (sections 4 and 6). For each section, the total possible score is 5 and overall ODI score was expressed as a percentage of the maximum possible score (10). Total score increases with worsening disability.
Measured: baseline (pre-1st injection) to 6 months post-1st injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: biostatistician determined 20 subjects would be adequate to perform statistics
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 Spinal Stenosis, Lumbar Region, With Neurogenic ClaudicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshfield Clinic Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Farooque, MD, Marshfield Clinic Research Foundation
- Investigators
- Mustafa Farooque, MD, Principal investigator, Marshfield Clinic/MCRFJames Burmester, PhD, Principal investigator, Marshfield Clinic Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995461
- Sponsor's protocol ID
- FAR10112
- Status last verified
- Oct 2015
- First submitted
- 18 Nov 2013
- Last updated
- 24 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bilateral Transforaminal Epidural Steroid Injections in Degenerative Lumbar Spinal Stenosis Patients With Neurogenic Claudication: A Prospective Outcome Study
- ClinicalTrials.gov ID
- NCT01995461
- Acronym / sponsor ID
- FAR10112
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: biostatistician determined 20 subjects would be adequate to perform statistics
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Marshfield Clinic Research FoundationUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Posted 24 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The most common forms of injection used for the treatment of degenerative lumbar spinal stenosis (DLSS) patients with neurogenic claudication (NC) are the caudal and inter-laminar epidural injections of anesthetic and steroid. Unilateral transforaminal epidural steroid injections (TESI) are also used to alleviate patients' symptoms of NC from DLSS, particularly in patients whose level of stenosis is L4-5 or higher. However, these unilateral injections do not cross the midline, so in cases of lower extremity pain and symptoms on both sides, a bilateral TESI would probably be more beneficial.
To date, there have not been any well designed prospective studies to determine the effectiveness of bilateral TESI below the level of stenosis in DLSS patients with NC. Therefore, the goal of this prospective, non-randomized case-series outcome study is to evaluate the effectiveness of BTESI in alleviating symptoms of NC, as well as improving function in patients with DLSS. The hypothesis is that BTESI at the level below the most stenotic segment of the central canal of the lumbar spine decreases symptoms of NC and improves function in patients with DLSS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTESI | Experimental | Drug: bilateral transforaminal epidural steroid injectionsa prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI) |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptoms of back/buttock/leg pain (NOT radicular pain) in a neurogenic claudicatory fashion, relieved by stooping or sitting down, for at least 3 months with no or poor response to conservative treatment (analgesics, NSAIDs, or physical therapy)
- Patients with bilateral buttock and/or bilateral lower extremity pain in a neurogenic fashion with or without lower back pain
- Radiologic documentation of degree of degenerative lumbar spinal stenosis (DLSS)
- MRI/CT showing at least moderate central canal spinal stenosis (neuro-radiologist definition) with symptoms correlating with stenosis (symptoms of back/buttock/leg pain without unilateral radicular pain in a neurogenic claudicatory fashion, relieved by stooping or sitting down)
- Patients choosing to receive BTESI as their next treatment option, following discussions with their spine doctor
Key exclusion criteria (14 listed)
- Radiologic spinal stenosis without symptoms of spinal stenosis
- Symptoms of neurogenic claudication without at least moderate degree of radiologic spinal stenosis
- Patients with specific lumbo-sacral radicular symptoms or radiculopathy (radicular pain secondary to a single nerve root compression/inflammation; usually follows a specific dermatome in lower extremities; unilateral radiculopathy either from disc herniation or lateral recess stenosis)
- Patients with vascular claudication (pain in the legs secondary to arterial insufficiency)
- Previous lumbo-sacral surgery
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 |
|---|---|---|
| bilateral transforaminal epidural steroid injectionsAlso: BTESIBTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection. | Drug | BTESI |
Primary outcome
Change From Baseline Pain Score at 6 Months
Time frame: baseline (pre-1st injection) to 6 months post-1st injection
change from baseline (pre-1st injection) pain score, based on a numeric pain scale of 0-10(most severe pain), at 6 months post-1st injection
2 secondary outcomes
Change From Baseline Swiss Spinal Stenosis Score at 6 Months
Time frame: baseline (pre-1st injection) to 6 months post-1st injection
Change From Baseline Oswestry Disability Index at 6 Months
Time frame: baseline (pre-1st injection) to 6 months post-1st injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mustafa Farooque, MD principal investigator
Marshfield Clinic/MCRF
James Burmester, PhD principal investigator
Marshfield Clinic Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral transforaminal epidural steroid injections in people with Spinal Stenosis, Lumbar Region, With Neurogenic Claudication, run by Marshfield Clinic Research Foundation 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: stopped early, as of the sponsor's last update on 24 Nov 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?
Yes. Results are posted in the registry (first posted 24 Nov 2015). 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?
Change From Baseline Pain Score at 6 Months (time frame: baseline (pre-1st injection) to 6 months post-1st injection). 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 24 Nov 2015.