A Phase 4 interventional study of Epidural steroid with local anesthetic injection and Epidural local anesthetic injection in Spinal Stenosis and Low Back Pain, sponsored by University of Washington. Completed at 10 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-12-13.
Sponsored by University of Washington · Phase 4, Interventional, and Treatment
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.
Lumbar spinal stenosis is one of the most common causes of low back pain in the elderly and can lead to significant disability. The symptoms of spinal stenosis range from low back pain to neurogenic claudication with lower extremity pain, weakness and/or sensory changes related to activities. As spinal stenosis can affect the central canal as well as the lateral recesses and intervertebral foramen variably, symptoms can involve single or multiple myotomes and dermatomes. Since the causes of spinal stenosis are most frequently degenerative changes, the symptoms of spinal stenosis often, but not always, worsen over time. Despite the prevalence of spinal stenosis, treatment of spinal stenosis remains somewhat controversial. Common treatments include conservative measures such as non-steroidal anti-inflammatories (NSAIDS), activity modification and physical therapy as well as more invasive treatments such as epidural steroid injections and surgery. Although surgery has been demonstrated to provide some benefit to many individuals with spinal stenosis, ESI are being used with increasing frequency as a less invasive, potentially more cost effective and safer treatment for spinal stenosis. However, there is a lack of data to demonstrate the effectiveness and safety of epidural steroid injections for spinal stenosis, particularly in the older adults.
Because of the compelling need for effective therapy for patients suffering from spinal stenosis and because epidural steroid injections are rapidly becoming standard of care for treating these patients - even in the absence of compelling clinical evidence - we are conducting a randomized, controlled trial in order to test the hypothesis that lumbar epidural steroid injections improve functional status and pain associated with spinal stenosis. The main objective of the study is to conduct a blinded, randomized controlled trial (RCT) in elderly patients with spinal stenosis to test if the effectiveness of epidural steroid injections (ESI) plus local anesthetic (LA) is greater than LA alone.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's enrollment of 400 is above the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
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
Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe. Intervention: Epidural steroid with local anesthetic injection 2cc of .25 - 1% lidocaine and glucocorticoid (Kenalog 40-120 mg, depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg)
Procedure: Epidural steroid with local anesthetic injection · Drug: Epidural steroid injection
Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Procedure: Epidural local anesthetic injection · Drug: Epidural local anesthetic injection
Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.
Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.
Also known as: Kenalog, depo-medrol, betamethasone or dexamethasone
Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Also known as: lidocaine
Roland Morris
The primary outcome measure will be back specific functional status, measured by the Roland Scale at 6 weeks. The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection.
Time frame: 6 weeks
Pain Numeric Rating Scale
Leg Pain NRS is a second primary outcome at 6 weeks We measured leg pain using a 0-10 pain NRS (0=no pain and 10=worst pain imaginable) assessing average pain over the past week.
Time frame: 6 weeks
Roland Morris Disability Questionnaire (RDQ)
The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection.
Time frame: 12 months
Leg Pain NRS
Leg Pain NRS 0-10 scale
Time frame: 12 months
| Milestone | Epidural Steroid Injection | Epidural Local Anesthetic Injection |
|---|---|---|
| Started | 200 | 200 |
| Completed | 153 | 150 |
| Not completed | 47 | 50 |
The primary outcome measure will be back specific functional status, measured by the Roland Scale at 6 weeks. The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection.
| units on a scale | Epidural Steroid Injection | Epidural Local Anesthetic Injection |
|---|---|---|
| Roland Morris | 11.8 ± 6.3 | 12.5 ± 6.4 |
Leg Pain NRS is a second primary outcome at 6 weeks We measured leg pain using a 0-10 pain NRS (0=no pain and 10=worst pain imaginable) assessing average pain over the past week.
| units on a scale | Epidural Steroid Injection | Epidural Local Anesthetic Injection |
|---|---|---|
| Pain Numeric Rating Scale | 4.4 ± 2.9 | 4.6 ± 2.9 |
The RDQ is a back pain specific functional status questionnaire adapted from the Sickness Impact Profile (SIP). The RDQ consists of 24 yes/no items, which represent common dysfunctions in daily activities experienced by subjects with low back pain. A single unweighted score is derived by summing the 24 items, with higher scores indicating worse function with 0 (no disability) to 24 (maximum disability). Our primary analysis will be a simple 2-group comparison of the mean Roland score as an evaluation of the short-term efficacy of epidural steroid injection.
| units on a scale | Epidural Steroid Injection | Epidural Local Anesthetic Injection |
|---|---|---|
| Roland Morris Disability Questionnaire (RDQ) | 12.0 ± 6.5 | 11.5 ± 7.1 |
Leg Pain NRS 0-10 scale
| units on a scale | Epidural Steroid Injection | Epidural Local Anesthetic Injection |
|---|---|---|
| Leg Pain NRS | 4.7 ± 3.1 | 4.3 ± 3.1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Epidural Steroid Injection | — | 5/200 (2.5%) | 43/200 (21.5%) |
| Epidural Local Anesthetic Injection | — | 4/200 (2%) | 31/200 (15.5%) |
| Event | Epidural Steroid Injection | Epidural Local Anesthetic Injection |
|---|---|---|
| Hospitalization or SurgerySurgical and medical procedures | 5/200 | 4/200 |
| Event | Epidural Steroid Injection | Epidural Local Anesthetic Injection |
|---|---|---|
| All other self reported adverse eventsGeneral disorders | 43/200 | 31/200 |
| Dural punctureInjury, poisoning and procedural complications | 1/200 | 1/200 |
| Age, Continuous(years) | Epidural Steroid Injection | Epidural Local Anesthetic Injection | Total |
|---|---|---|---|
| Mean | 68.0 ± 9.8 | 68.1 ± 10.2 | 68 ± 10.0 |
| Sex: Female, Male(Participants) | Epidural Steroid Injection | Epidural Local Anesthetic Injection | Total |
|---|---|---|---|
| Female | 117 | 104 | 221 |
| Male | 83 | 96 | 179 |
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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