Trial Outcomes & Findings for A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy (NCT NCT00733096)

Results Overview

0-10 pain score. 0= no pain, 10= worst imaginable pain.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

84 participants

Primary outcome timeframe

1 month

Results posted on

2012-10-08

Participant Flow

84 patients were enrolled between 2008 and 2011

80 patients were excluded before assignment

Participant milestones

Participant milestones
Measure	Steroid Two epidural steroid injections	Etanercept Two epidural etanercept injections	Saline Two epidural saline injections
Overall Study STARTED	28	26	30
Overall Study COMPLETED	28	26	30
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Steroid n=28 Participants Two epidural steroid injections	Etanercept n=26 Participants Two epidural etanercept injections	Saline n=30 Participants Two epidural saline injections	Total n=84 Participants Total of all reporting groups
Age Continuous	41.4 years STANDARD_DEVIATION 12.7 • n=5 Participants	43.2 years STANDARD_DEVIATION 8.9 • n=7 Participants	42.3 years STANDARD_DEVIATION 10.7 • n=5 Participants	42.29 years STANDARD_DEVIATION 10.80 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	59 Participants n=4 Participants
Region of Enrollment United States	28 participants n=5 Participants	26 participants n=7 Participants	30 participants n=5 Participants	84 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Patients who received epidural steroid injections

0-10 pain score. 0= no pain, 10= worst imaginable pain.

Outcome measures

Outcome measures
Measure	Steroid n=28 Participants Two epidural steroid injections	Etanercept n=26 Participants Two epidural etanercept injections	Saline n=30 Participants Two epidural saline injections
Numerical Rating Leg Pain Score	2.54 units on a scale Interval 1.36 to 3.69	3.56 units on a scale Interval 2.35 to 4.72	3.78 units on a scale Interval 2.72 to 4.85

SECONDARY outcome

Timeframe: 1 month

Population: Patients who received epidural steroid injections

0-100%. 0= no disability, 100% is complete disability

Outcome measures

Outcome measures
Measure	Steroid n=28 Participants Two epidural steroid injections	Etanercept n=26 Participants Two epidural etanercept injections	Saline n=30 Participants Two epidural saline injections
Oswestry Disability Score	22.4 percentage of disability out of 100% Interval 16.64 to 31.55	40.26 percentage of disability out of 100% Interval 32.91 to 47.61	30.00 percentage of disability out of 100% Interval 23.2 to 36.69

SECONDARY outcome

Timeframe: 1 month

Population: Subjects who underwent epidural steroid injections

Satisfaction. Number of participants with positive perceived global satisfaction.

Outcome measures

Outcome measures
Measure	Steroid n=28 Participants Two epidural steroid injections	Etanercept n=26 Participants Two epidural etanercept injections	Saline n=30 Participants Two epidural saline injections
Global Perceived Effect	23 participants	15 participants	17 participants

SECONDARY outcome

Timeframe: 1 month

Population: Patients who underwent epidural steroid injections

Number of people who reduced medications

Outcome measures

Outcome measures
Measure	Steroid n=28 Participants Two epidural steroid injections	Etanercept n=26 Participants Two epidural etanercept injections	Saline n=30 Participants Two epidural saline injections
Medication Reduction	17 participants	9 participants	14 participants

Adverse Events

Steroid

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Etanercept

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Steroid n=28 participants at risk Two epidural steroid injections	Etanercept n=26 participants at risk Two epidural etanercept injections	Saline n=30 participants at risk Two epidural saline injections
General disorders Worsening pain	0.00% 0/28	15.4% 4/26	10.0% 3/30
Infections and infestations Nonlocal infection	0.00% 0/28	3.8% 1/26	10.0% 3/30
Infections and infestations Nonlocal rash	3.6% 1/28	0.00% 0/26	0.00% 0/30

Additional Information

Steven P. Cohen

Johns Hopkins School of Medicine

Phone: 410-955-1822

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place