Phase 4
N=400
Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)
Spinal Stenosis · Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01238536 ↗Enrolled (actual)
400
Serious AEs
2.3%
Results posted
Dec 2017
Primary outcome: Primary: Roland Morris — 11.8; 12.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Epidural steroid with local anesthetic injection (Procedure); Epidural local anesthetic injection (Procedure); Epidural steroid injection (Drug); Epidural local anesthetic injection (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Roland Morris |
11.8; 12.5 | — |
| SECONDARY Pain Numeric Rating Scale |
4.4; 4.6 | — |
| SECONDARY Roland Morris Disability Questionnaire (RDQ) |
12.0; 11.5 | — |
| SECONDARY Leg Pain NRS |
4.7; 4.3 | — |
Summary
The broad, long-term objective of this research protocol is to improve the quality of life for patients suffering from lumbar spinal stenosis. This objective will be met by examining the safety and clinical efficacy of epidural steroid injections for treatment of pain associated with lumbar spinal stenosis. This prospective, randomized, double-blind controlled trial (RCT) will test the hypothesis that the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than epidural injections of LA alone in older adults with lumbar spinal stenosis.
Eligibility Criteria
Inclusion Criteria
- Pain in the low back, buttock, and/or lower extremity (pain NRS>=5) with standing, walking and/or spinal extension (buttock/leg>back pain).
- Modified Roland-Morris score of at least 7.
- Mild-severe lumbar central canal spinal stenosis (Boden et al. criteria18) identified by MRI or CT scan.
- Lower extremity symptoms consistent with neurogenic claudication.
- Must be able to read English and complete the assessment instruments.
- Age 50 or older.
Exclusion Criteria
- Cognitive impairment that renders the patient unable to give informed consent or provide accurate data.
- Clinical co-morbidities that could interfere with the collection of data concerning pain and function.
Known dx of fibromyalgia, chronic widespread pain, amputees, parkinsons, head injury, dementia, stroke, other neurologic conditions Collect date about cervical spinal stenosis, painful peripheral neuropathy, EMGs
- Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within 6 months).
- Spinal instability requiring surgical fusion.
- Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.
- Metastatic cancer.
- Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.
- Possible pregnancy or other reason that precludes the use of fluoroscopy.
- Concordant pain with internal rotation of the hip (or known hip joint pathology).
- Active local or systemic infection.
- Abnormal coagulation.
- Allergy to local anesthetic, steroid or contrast.
- Previous lumbar spine surgery.
- Epidural steroid injection within previous 6 months.
Data sourced from ClinicalTrials.gov (NCT01238536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.