Trial Outcomes & Findings for Steroids Versus Gabapentin (NCT NCT01495923)

NCT ID: NCT01495923

Last Updated: 2017-04-11

Results Overview

This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 145 participants
• Primary outcome timeframe: 1 month after the start of treatment
• Results posted on: 2017-04-11

Participant Flow

Between December 15, 2011 and June 10, 2014 145 participants were recruited at 8 sites. The sites included 4 joint service military treatment facilities, 3 of which serve as teaching hospitals and 1 of which is located in Europe; a Veteran's Administration hospital; and 3 civilian teaching hospitals.

Participant milestones

Measure	Epidural Steroid Injection If randomized to this group, participants received either a transforaminal injection for unilateral pain or an interlaminar injection for bilateral pain and placebo medication. The level and type of injection to be given was determined by signs, symptoms, and radiological findings.	Gabapentin If randomized to this group participants received gabapentin medication and a placebo intramuscular injection. The gabapentin was uptitrated to a therapeutic dose using a titration schedule.
Overall Study STARTED	73	72
Overall Study COMPLETED	73	72
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Steroids Versus Gabapentin

Baseline characteristics by cohort

Measure	Epidural Steriod Injections n=73 Participants Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive a real epidural steroid injection and placebo medication as treatment.	Gabapentin n=72 Participants Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive real gabapentin and a placebo injection as treatment.	Total n=145 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	73 Participants n=5 Participants	72 Participants n=7 Participants	145 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 14 • n=5 Participants	41.7 years STANDARD_DEVIATION 11.9 • n=7 Participants	42.7 years STANDARD_DEVIATION 13.01 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	13 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	59 Participants n=7 Participants	107 Participants n=5 Participants
Region of Enrollment United States	67 participants n=5 Participants	67 participants n=7 Participants	134 participants n=5 Participants
Region of Enrollment Germany	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month after the start of treatment

This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

Outcome measures

Measure	Epidural Steroid Injection n=73 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=72 Participants This group received gabapentin medication and a placebo injection.
Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale	3.3 units on a scale Standard Deviation 2.6	3.7 units on a scale Standard Deviation 2.6

PRIMARY outcome

Timeframe: 3 months from the start of treatment

This outcome measure compares the average leg pain at baseline to the average leg pain 3 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

Outcome measures

Measure	Epidural Steroid Injection n=72 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=73 Participants This group received gabapentin medication and a placebo injection.
Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale	3.7 units on a scale Standard Deviation 2.8	3.4 units on a scale Standard Deviation 2.7

PRIMARY outcome

Timeframe: 1 month from the start of treatment

This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

Outcome measures

Measure	Epidural Steroid Injection n=73 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=72 Participants This group received gabapentin medication and a placebo injection.
Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale	4.9 units on a scale Standard Deviation 3.1	5.8 units on a scale Standard Deviation 3.0

PRIMARY outcome

Timeframe: 3 months from the start of treatment

This outcome measure compares the worst leg pain at baseline to the worst leg pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

Outcome measures

Measure	Epidural Steroid Injection n=73 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=72 Participants This group received gabapentin medication and a placebo injection.
Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale	5.2 units on a scale Standard Deviation 3.4	5.5 units on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: 1 month fromt he start of treatment

This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

Outcome measures

Measure	Epidural Steroid Injection n=73 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=72 Participants This group received gabapentin medication and a placebo injection.
Average Back Pain at 1 Month Measured Using the Numeric Pain Scale	3.5 units on a scale Standard Deviation 2.6	3.6 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 3 months from the start of treatment

This outcome measure compares the average back pain at baseline to the average back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

Outcome measures

Measure	Epidural Steroid Injection n=73 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=72 Participants This group received gabapentin medication and a placebo injection.
Average Back Pain at 3 Months Measured Using the Numeric Pain Scale	3.9 units on a scale Standard Deviation 2.7	3.7 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 1 month after the start of treatment

Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.

Outcome measures

Measure	Epidural Steroid Injection n=73 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=72 Participants This group received gabapentin medication and a placebo injection.
Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index	32.6 units on a scale Standard Deviation 18.3	29.6 units on a scale Standard Deviation 16.0

SECONDARY outcome

Timeframe: 3 months after the start of treatment

Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.

Outcome measures

Measure	Epidural Steroid Injection n=73 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=72 Participants This group received gabapentin medication and a placebo injection.
Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index	33.6 participants Standard Deviation 19.4	29.6 participants Standard Deviation 16.3

SECONDARY outcome

Timeframe: 3 months after the start of treatment

The participant is asked "Are you satisfied with the treatment you have received so far? Participants could respond yes or no. This is measured 3 months after the start of treatment.

Outcome measures

Measure	Epidural Steroid Injection n=73 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=72 Participants This group received gabapentin medication and a placebo injection.
Global Perceived Effect of Treatment at 3 Months After the Start of Treatment Yes	27 Participants	21 Participants
Global Perceived Effect of Treatment at 3 Months After the Start of Treatment No	46 Participants	51 Participants

SECONDARY outcome

Timeframe: 1 month after the start of treatment

The participant is asked "Are you satisfied with the treatment you have received so far? Participants could respond yes or no. This is measured 1 month after the start of treatment.

Outcome measures

Measure	Epidural Steroid Injection n=73 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=72 Participants This group received gabapentin medication and a placebo injection.
Global Perceived Effect of Treatment at 1 Month After the Start of Treatment Yes	48 Participants	33 Participants
Global Perceived Effect of Treatment at 1 Month After the Start of Treatment No	25 Participants	39 Participants

SECONDARY outcome

Timeframe: 1 month from the start of treatment

This outcome measure compares the worst back pain at baseline to the worst back pain at 1 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

Outcome measures

Measure	Epidural Steroid Injection n=73 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=72 Participants This group received gabapentin medication and a placebo injection.
Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale	5.1 units on a scale Standard Deviation 2.9	5.4 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 3 months after the start of treatment

This outcome measure compares the worst back pain at baseline to the worst back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.

Outcome measures

Measure	Epidural Steroid Injection n=73 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=72 Participants This group received gabapentin medication and a placebo injection.
Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale	5.6 units on a scale Standard Deviation 3.2	5.6 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Measured within the year of enrollment in the study

Population: Data for this outcome measure was collected one year following the last follow-up. Data was not available for one participant in the epidural steroid injection arm and for three in the gabapentin arm.

This is a measure of participants that proceeded to surgery within a year of enrollment

Outcome measures

Measure	Epidural Steroid Injection n=72 Participants This group received an epidural steroid injection and placebo medication.	Gabapentin n=69 Participants This group received gabapentin medication and a placebo injection.
Proceeded to Surgery Within Year of Enrollment	9 Participants	10 Participants

Adverse Events

Epidural Steroids

Serious events: 15 serious events

Other events: 24 other events

Deaths: 0 deaths

Gabapentin

Serious events: 19 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Epidural Steroids n=73 participants at risk Injection of steroids into the epidural space epidural steroid injection: Injection of steroids and local anesthetic into the epidural space Placebo gabapentin: Titration of placebo gabapentin	Gabapentin n=72 participants at risk Titration of gabapentin to effect Sham epidural steroid injection: Injection of saline into the back muscles Gabapentin: Titration of gabapentin to effect
Musculoskeletal and connective tissue disorders Excessive pain	1.4% 1/73 • Number of events 1	5.6% 4/72 • Number of events 4
Infections and infestations Fever or infection	2.7% 2/73 • Number of events 2	0.00% 0/72
Injury, poisoning and procedural complications Fall	1.4% 1/73 • Number of events 1	0.00% 0/72
Cardiac disorders Vasovagal	0.00% 0/73	2.8% 2/72 • Number of events 2
Nervous system disorders Coginitve	6.8% 5/73 • Number of events 5	9.7% 7/72 • Number of events 7
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Headache	5.5% 4/73 • Number of events 4	1.4% 1/72 • Number of events 1
Immune system disorders Swelling	0.00% 0/73	4.2% 3/72 • Number of events 3
Nervous system disorders Ataxia	1.4% 1/73 • Number of events 1	2.8% 2/72 • Number of events 2
Musculoskeletal and connective tissue disorders Muscle Twitching	1.4% 1/73 • Number of events 1	0.00% 0/72

Other adverse events

Measure	Epidural Steroids n=73 participants at risk Injection of steroids into the epidural space epidural steroid injection: Injection of steroids and local anesthetic into the epidural space Placebo gabapentin: Titration of placebo gabapentin	Gabapentin n=72 participants at risk Titration of gabapentin to effect Sham epidural steroid injection: Injection of saline into the back muscles Gabapentin: Titration of gabapentin to effect
Gastrointestinal disorders Gastrointestinal Upset	17.8% 13/73 • Number of events 13	11.1% 8/72 • Number of events 8
Metabolism and nutrition disorders Weight Gain	5.5% 4/73 • Number of events 4	9.7% 7/72 • Number of events 7
Nervous system disorders Sedation Fatigue	9.6% 7/73 • Number of events 7	15.3% 11/72 • Number of events 11

Additional Information

Steven Cohen

The Johns Hopkins Hospital

Phone: 410-955-1818

Email: scohen40@jhmi.edu

Results disclosure agreements

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