Lumbar Spinal Stenosis
Conditions
Brief summary
Chronic lumbosacral radiculopathy secondary to lumbar spinal stenosis affects a large number of individuals, and there is a general lack of consensus in the medical community in terms of effective treatments for this problem. By assessing the relative efficacy of transforaminal epidural injections of particulate and nonparticulate steroids, this study attempts to further define the appropriate conservative management of painful unilateral radiculopathies due to unilateral lumbar foraminal stenosis. Patients will be randomized to receive a transforaminal epidural injection of either a particulate (Kenalog) or nonparticulate (Decadron) steroid. Outcomes will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months following the injection.
Interventions
DRUGKenalog Injectable Product
80 mg of Kenalog will be used.
DRUGDecadron Phosphate, Injectable
15 mg of Decadron will be used.
PROCEDUREEpidural Steroid Injection
Patient will receive epidural steroid injections of either Kenalog or Decadron.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* English speaking/reading adults age 18-90 years * Patients with complaints of unilateral radicular lower extremity symptoms * NRS pain score \>= 5 * Pain symptoms for at least 1 month's duration * Patients deemed appropriate for lumbar transforaminal epidural steroid injections by treating spine specialist * Targeted injection level for L4 or L5 * MRI of lumbosacral spine that demonstrates and confirms single-level neural compression secondary to unilateral lumbosacral foraminal or subarticular stenosis consistent with clinical history and findings * Lumbar foraminal stenosis severity of grades 1, 2, and 3
Exclusion criteria
* Patients with multiple symptomatic levels * Patients who are deemed not appropriate to undergo lumbar transforaminal epidural steroid injections (e.g., allergy to local anesthetics, radiographic dye contrast, patients with high bleeding tendency, pregnancy) * Patients involved with litigation or worker's compensation cases * Patients who are unable to answer the questionnaires and perform follow-up visits * Patients who have active, concurrent painful diagnoses (e.g., hip osteoarthritis, greater trochanteric pain syndrome, knee pain, peripheral vascular disease, or peripheral neuropathy) that may confuse clinical picture and impact patients' rating and perception of their low back and radicular symptoms * Patients with other spinal pathologies confirmed on imaging that may explain patient's pain * Patients who have additional severe foraminal stenosis inferior to the symptomatic level (e.g., symptomatic L4 foraminal stenosis with severe L5 foraminal stenosis) will not have those levels injected * Non-English speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in function (6 months post-injection) | 6 months post-injection | This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations). |
| Improvement in function (2 weeks post-injection) | 2 weeks post-injection | This will be measured using the Oswestry Disability Index (ODI; 0-100 scale). A higher score represents greater disability (greater pain and functional limitations). |
| Improvement in function (6 weeks post-injection) | 6 weeks post-injection | This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations). |
| Improvement in function (3 months post-injection) | 3 months post-injection | This will be measured using the ODI (0-100 scale). A higher score represents greater disability (greater pain and functional limitations). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication use | 2 weeks, 6 weeks, 3 months, and 6 months post-injection | The use of any pain medications (e.g., opioids, anti-inflammatory drugs, neuropathic medications) will be collected. |
| Patient satisfaction with the procedure | 2 weeks, 6 weeks, 3 months, and 6 months post-injection | Satisfaction will be assessed using the North American Spine Society Outcome Questionnaire. Patients will be asked to pick from 4 multiple choice statements regarding their satisfaction with their procedure. |
| Quality of life | 2 weeks, 6 weeks, 3 months, and 6 months post-injection | This will be assessed using the Veterans RAND 12-item Health Survey. |
| Side effects | 2 weeks, 6 weeks, 3 months, and 6 months post-injection | Side effects, including bleeding, infection, allergic reaction, dural puncture, nerve damage, and paralysis, will be collected. |
Countries
United States
Outcome results
None listed