Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology, Orthopedic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 40 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | June 2014 |
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.
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.
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.
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