Trial Outcomes & Findings for Lumbar Epidural Steroid Injections for Spinal Stenosis Multicenter Randomized, Controlled Trial (LESS Trial) (NCT NCT01238536)

NCT ID: NCT01238536

Last Updated: 2017-12-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 400 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2017-12-13

Participant Flow

Participant milestones

Measure	Epidural Steroid Injection 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.	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. Epidural local anesthetic injection: Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
Overall Study STARTED	200	200
Overall Study COMPLETED	153	150
Overall Study NOT COMPLETED	47	50

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Total n=400 Participants Total of all reporting groups	Epidural Steroid Injection n=200 Participants 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.	Epidural Local Anesthetic Injection n=200 Participants 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.
Age, Continuous	68 years STANDARD_DEVIATION 10.0 • n=5 Participants	68.0 years STANDARD_DEVIATION 9.8 • n=5 Participants	68.1 years STANDARD_DEVIATION 10.2 • n=7 Participants
Sex: Female, Male Female	221 Participants n=5 Participants	117 Participants n=5 Participants	104 Participants n=7 Participants
Sex: Female, Male Male	179 Participants n=5 Participants	83 Participants n=5 Participants	96 Participants n=7 Participants

PRIMARY outcome

Timeframe: 6 weeks

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

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.

Outcome measures

Measure	Epidural Steroid Injection n=193 Participants 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.	Epidural Local Anesthetic Injection n=193 Participants 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.
Roland Morris	11.8 units on a scale Standard Deviation 6.3	12.5 units on a scale Standard Deviation 6.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Epidural Steroid Injection n=193 Participants 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.	Epidural Local Anesthetic Injection n=193 Participants 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.
Pain Numeric Rating Scale	4.4 units on a scale Standard Deviation 2.9	4.6 units on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Epidural Steroid Injection n=180 Participants 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.	Epidural Local Anesthetic Injection n=174 Participants 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.
Roland Morris Disability Questionnaire (RDQ)	12.0 units on a scale Standard Deviation 6.5	11.5 units on a scale Standard Deviation 7.1

SECONDARY outcome

Timeframe: 12 months

Leg Pain NRS 0-10 scale

Outcome measures

Measure	Epidural Steroid Injection n=180 Participants 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.	Epidural Local Anesthetic Injection n=174 Participants 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.
Leg Pain NRS	4.7 units on a scale Standard Deviation 3.1	4.3 units on a scale Standard Deviation 3.1

Adverse Events

Epidural Steroid Injection

Serious events: 5 serious events

Other events: 43 other events

Deaths: 0 deaths

Epidural Local Anesthetic Injection

Serious events: 4 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Epidural Steroid Injection n=200 participants at risk 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.	Epidural Local Anesthetic Injection n=200 participants at risk 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.
Surgical and medical procedures Hospitalization or Surgery	2.5% 5/200 • Number of events 5	2.0% 4/200 • Number of events 4

Other adverse events

Measure	Epidural Steroid Injection n=200 participants at risk 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.	Epidural Local Anesthetic Injection n=200 participants at risk 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.
Injury, poisoning and procedural complications Dural puncture	0.50% 1/200 • Number of events 1	0.50% 1/200 • Number of events 1
General disorders All other self reported adverse events	21.5% 43/200 • Number of events 57	15.5% 31/200 • Number of events 33

Additional Information

Janna Friedly M.D.

University of Washington

Phone: 206-744-3664

Email: friedlyj@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60