Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Conditions
Brief 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. 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.
Interventions
DRUGbilateral transforaminal epidural steroid injections
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.
Sponsors
Marshfield Clinic Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Pain Score at 6 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Swiss Spinal Stenosis Score at 6 Months | baseline (pre-1st injection) to 6 months post-1st injection | 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. |
| Change From Baseline Oswestry Disability Index at 6 Months | baseline (pre-1st injection) to 6 months post-1st injection | 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. |
Other
| Measure | Time frame |
|---|---|
| Change From Baseline Pain Medication Need/Use at 6 Months | baseline (pre-1st injection) to 6 months post-1st injection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BTESI a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)
bilateral transforaminal epidural steroid injections: 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. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | BTESI |
|---|---|
| Age, Continuous | 74.7 years |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
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
Time frame: baseline (pre-1st injection) to 6 months post-1st injection
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BTESI | Change From Baseline Pain Score at 6 Months | -1.6 points |
p-value: 0.0252t-test, 2 sided
Secondary
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.
Time frame: baseline (pre-1st injection) to 6 months post-1st injection
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BTESI | Change From Baseline Oswestry Disability Index at 6 Months | -7.1 points |
p-value: 0.1349t-test, 2 sided
Secondary
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.
Time frame: baseline (pre-1st injection) to 6 months post-1st injection
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BTESI | Change From Baseline Swiss Spinal Stenosis Score at 6 Months | -8.3 points |
p-value: 0.0154t-test, 2 sided
Other Pre-specified
Change From Baseline Pain Medication Need/Use at 6 Months
Time frame: baseline (pre-1st injection) to 6 months post-1st injection