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

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT01238536
• Collaborator: Kaiser Permanente (Other), University of California, San Francisco (Other), Henry Ford Hospital (Other), Harvard Pilgrim Health Care (Other), Harvard Vanguard Medical Associates (Other), University of Colorado, Denver (Other), Mayo Clinic (Other), Stanford University (Other), Massachusetts General Hospital (Other), Virginia Spine Research Institute (Other), Oregon Health and Science University (Other), Dallas VA Medical Center (U.S. Fed)
• Enrollment: 400
• Locations: 10
• Arms: 2
• Duration (Months): 53
• Patients Per Site: 40
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Stenosis; Low Back Pain	Procedure: Epidural steroid with local anesthetic injection; Procedure: Epidural local anesthetic injection; Drug: Epidural steroid injection; Drug: Epidural local anesthetic injection	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Multicenter Randomized Controlled Trial of Epidural Steroid Injections for Spinal Stenosis in Persons 50 and Older
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epidural Steroid injection 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; 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.; Drug: Epidural steroid injection; 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.; Other Names: Kenalog, depo-medrol, betamethasone or dexamethasone
Active Comparator: Epidural local anesthetic 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; Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.; Drug: Epidural local anesthetic injection; Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.; Other Names: lidocaine

Outcome Measures

Primary Outcome Measures

1. Roland Morris [6 weeks]

   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.

Secondary Outcome Measures

1. Pain Numeric Rating Scale [6 weeks]

   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.

2. Roland Morris Disability Questionnaire (RDQ) [12 months]

   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.

3. Leg Pain NRS [12 months]

   Leg Pain NRS 0-10 scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Pain in the low back, buttock, and/or lower extremity (pain NRS>=5) with standing, walking and/or spinal extension (buttock/leg>back pain).

2. Modified Roland-Morris score of at least 7.

3. Mild-severe lumbar central canal spinal stenosis (Boden et al. criteria18) identified by MRI or CT scan.

4. Lower extremity symptoms consistent with neurogenic claudication.

5. Must be able to read English and complete the assessment instruments.

6. Age 50 or older.

Exclusion Criteria:

1. Cognitive impairment that renders the patient unable to give informed consent or provide accurate data.

2. 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

1. Severe vascular, pulmonary or coronary artery disease that limits ambulation including recent myocardial infarction (within 6 months).

2. Spinal instability requiring surgical fusion.

3. Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.

4. Metastatic cancer.

5. Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.

6. Possible pregnancy or other reason that precludes the use of fluoroscopy.

7. Concordant pain with internal rotation of the hip (or known hip joint pathology).

8. Active local or systemic infection.

9. Abnormal coagulation.

10. Allergy to local anesthetic, steroid or contrast.

11. Previous lumbar spine surgery.

12. Epidural steroid injection within previous 6 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Northern California	Redwood City	California	United States	94063
2	Kaiser Permanente Northern California	Roseville	California	United States	95661
3	University of Colorado	Denver	Colorado	United States	80045
4	Brigham and Women's Hospital	Boston	Massachusetts	United States	02467
5	Henry Ford Hospital	Detroit	Michigan	United States	48202
6	Mayo Clinic	Rochester	Minnesota	United States	55905
7	Oregon Health and Science University	Portland	Oregon	United States
8	Dallas VA Medical Center	Dallas	Texas	United States	75216
9	Virginia Spine Research Institute	Richmond	Virginia	United States	23235
10	Harborview Medical Center, University of Washington	Seattle	Washington	United States	98104

Sponsors and Collaborators

• University of Washington
• Kaiser Permanente
• University of California, San Francisco
• Henry Ford Hospital
• Harvard Pilgrim Health Care
• Harvard Vanguard Medical Associates
• University of Colorado, Denver
• Mayo Clinic
• Stanford University
• Massachusetts General Hospital
• Virginia Spine Research Institute
• Oregon Health and Science University
• Dallas VA Medical Center

Investigators

• Principal Investigator: Janna L Friedly, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

• Friedly JL, Bresnahan BW, Comstock B, Turner JA, Deyo RA, Sullivan SD, Heagerty P, Bauer Z, Nedeljkovic SS, Avins AL, Nerenz D, Jarvik JG. Study protocol- Lumbar Epidural steroid injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults. BMC Musculoskelet Disord. 2012 Mar 29;13:48. doi: 10.1186/1471-2474-13-48.

• Responsible Party: Janna Friedly, Assistant Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT01238536
• Other Study ID Numbers: 39023D; R01HS019222-01
• First Posted: Nov 10, 2010
• Last Update Posted: Dec 13, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by Janna Friedly, Assistant Professor, University of Washington: Epidural Steroid Injection; Low Back Pain; Spinal Stenosis; Elderly
• Additional relevant MeSH terms: Spinal Stenosis; Back Pain; Low Back Pain; Constriction, Pathologic; Dexamethasone; Betamethasone; Methylprednisolone Acetate; Lidocaine; Anesthetics, Local; Anesthetics

Study Results

Participant Flow

Arm/Group Title	Epidural Steroid Injection	Epidural Local Anesthetic Injection
Arm/Group Description	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)in an opaque syringe. Epidural steroid with 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 steroid injection: 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 injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe. Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Period Title: Overall Study
STARTED	200	200
COMPLETED	153	150
NOT COMPLETED	47	50

Baseline Characteristics

Arm/Group Title	Epidural Steroid Injection	Epidural Local Anesthetic Injection	Total
Arm/Group Description	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)in an opaque syringe. Epidural steroid with 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 steroid injection: 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 injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe. Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.	Total of all reporting groups
Overall Participants	200	200	400
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.0 (9.8)	68.1 (10.2)	68 (10.0)
Sex: Female, Male (Count of Participants)
Female	117 58.5%	104 52%	221 55.3%
Male	83 41.5%	96 48%	179 44.8%

Outcome Measures

1. Primary Outcome

Title	Roland Morris
Description	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

Outcome Measure Data

Analysis Population Description

6 week follow up rate was 97% (n=193/200, n=193/200).

Arm/Group Title	Epidural Steroid Injection	Epidural Local Anesthetic Injection
Arm/Group Description	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)in an opaque syringe. Epidural steroid with 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 steroid injection: 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 injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe. Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Measure Participants	193	193
Mean (Standard Deviation) [units on a scale]	11.8 (6.3)	12.5 (6.4)

2. Secondary Outcome

Title	Pain Numeric Rating Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural Steroid Injection	Epidural Local Anesthetic Injection
Arm/Group Description	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)in an opaque syringe. Epidural steroid with 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 steroid injection: 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 injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe. Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Measure Participants	193	193
Mean (Standard Deviation) [units on a scale]	4.4 (2.9)	4.6 (2.9)

3. Secondary Outcome

Title	Roland Morris Disability Questionnaire (RDQ)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural Steroid Injection	Epidural Local Anesthetic Injection
Arm/Group Description	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)	Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Measure Participants	180	174
Mean (Standard Deviation) [units on a scale]	12.0 (6.5)	11.5 (7.1)

4. Secondary Outcome

Title	Leg Pain NRS
Description	Leg Pain NRS 0-10 scale
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural Steroid Injection	Epidural Local Anesthetic Injection
Arm/Group Description	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)	Intervention: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Measure Participants	180	174
Mean (Standard Deviation) [units on a scale]	4.7 (3.1)	4.3 (3.1)

Adverse Events

Arm/Group Title	Epidural Steroid Injection		Epidural Local Anesthetic Injection
Arm/Group Description	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)in an opaque syringe. Epidural steroid with 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 steroid injection: 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 injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe. Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
All Cause Mortality
	Epidural Steroid Injection		Epidural Local Anesthetic Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Epidural Steroid Injection		Epidural Local Anesthetic Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/200 (2.5%)		4/200 (2%)
Surgical and medical procedures
Hospitalization or Surgery	5/200 (2.5%)	5	4/200 (2%)	4
Other (Not Including Serious) Adverse Events
	Epidural Steroid Injection		Epidural Local Anesthetic Injection
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/200 (21.5%)		31/200 (15.5%)
General disorders
All other self reported adverse events	43/200 (21.5%)	57	31/200 (15.5%)	33
Injury, poisoning and procedural complications
Dural puncture	1/200 (0.5%)	1	1/200 (0.5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.