Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial)

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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. criteria 18) 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Felix Diehn, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Felix Diehn, M.D.

Closed for enrollment

More information

Publications

Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis. Read More on PubMed

Clinical Trials