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| Name | Class |
|---|---|
| Walter Reed National Military Medical Center | FED |
| Brooke Army Medical Center | FED |
| Landstuhl Regional Medical Center | FED |
| Washington D.C. Veterans Affairs Medical Center |
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The purpose of this study is to determine whether pharmacotherapy or epidural steroid injections are a better treatment for lumbosacral radicular pain.
142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will be allocated to receive an epidural steroid injection (ESI; group I), with an equal number allocated to receive gabapentin (group II). Patients & evaluating physicians will be blinded. Follow-up will be through 3-months after treatment.
142 patients referred to a participating pain clinic with lumbosacral radiculopathy will be randomized in a 1:1 ratio to receive one of two treatments. Half (n=71) of the patients will be allocated to receive an ESI (group I), with an equal number allocated to receive gabapentin (group II).
Group I patients with unilateral symptoms will receive (unilateral) transforaminal ESI, while those with bilateral symptoms will receive (central) interlaminar ESI, as is common practice.
In group II patients who receive gabapentin, the dose will be titrated to between 1800 mg/d and 2700 mg/d in TID dosing, but may be lowered or elevated (up to 3600 mg/d) depending on the clinical circumstances. To ensure blinding, these patients will also receive midline (for patients with bilateral symptoms who would receive interlaminar ESI) or unilateral paraspinal (for patients with unilateral symptoms who would receive transforaminal ESI) normal saline into the interspinal ligaments or paraspinal musculature, respectively. Injections and medication titration will commence on the same day.
Rescue medications will consist of tramadol 50 mg 1 to 2 tablets every 6 hours PRN (up to 8/d) and/or ibuprofen 400-800 mg every 6 hours PRN (not-to-exceed 3000 mg/d). Patients already taking analgesics, including opioids, can continue on these medications "as needed".
The first follow-up visit will be scheduled 1-month from the start of treatment. A positive outcome will be defined as a > 2-point decrease in leg pain coupled with a positive satisfaction rating. Subjects who obtain a positive outcome at their initial 1-month follow-up visit will remain in the study and return for the final 3-month follow-up visit. Those with a negative outcome will exit the study "per protocol" to receive standard care, which may consist of unblinded ESI, medical management with drugs such as gabapentin (for those who did not receive gabapentin) and antidepressants, and physical therapy. Subjects who obtain a positive outcome at 1-month but experience a recurrence before their 3-month follow-up visit will also exit the study per protocol, with their final outcome measures recorded before they receive standard care. At all follow-up visits, pill counts will be conducted to determine medication compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural steroids | Experimental | Injection of steroids into the epidural space |
|
| Gabapentin | Active Comparator | Titration of gabapentin to effect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epidural steroid injection | Procedure | Injection of steroids and local anesthetic into the epidural space |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale | 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. | 1 month after the start of treatment |
| Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale | 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. | 3 months from the start of treatment |
| Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale | 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. | 1 month from the start of treatment |
| Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale | 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. | 3 months from the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Average Back Pain at 1 Month Measured Using the Numeric Pain Scale | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Steven P Cohen, MD | Walter Reed Army Institute of Research (WRAIR) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Hospital-San Diego | San Diego | California | 92134 | United States | ||
| Johns Hopkins |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25883095 | Derived | Cohen SP, Hanling S, Bicket MC, White RL, Veizi E, Kurihara C, Zhao Z, Hayek S, Guthmiller KB, Griffith SR, Gordin V, White MA, Vorobeychik Y, Pasquina PF. Epidural steroid injections compared with gabapentin for lumbosacral radicular pain: multicenter randomized double blind comparative efficacy study. BMJ. 2015 Apr 16;350:h1748. doi: 10.1136/bmj.h1748. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Epidural Steriod Injections | 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. |
| BG001 | Gabapentin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month after the start of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epidural Steroids | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Excessive pain | Musculoskeletal and connective tissue disorders | Excessive pain after epidural steroid injection or intramuscular injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Upset | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Cohen | The Johns Hopkins Hospital | 410-955-1818 | scohen40@jhmi.edu |
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| ID | Term |
|---|---|
| D012585 | Sciatica |
| D011843 | Radiculopathy |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| FED |
| United States Naval Medical Center, San Diego | FED |
| Case Western Reserve University | OTHER |
| Milton S. Hershey Medical Center | OTHER |
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| Sham epidural steroid injection | Procedure | Injection of saline into the back muscles |
|
| Gabapentin | Drug | Titration of gabapentin to effect |
|
| Placebo gabapentin | Drug | Titration of placebo gabapentin |
|
| 1 month fromt he start of treatment |
| Average Back Pain at 3 Months Measured Using the Numeric Pain Scale | 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. | 3 months from the start of treatment |
| Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index | 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. | 1 month after the start of treatment |
| Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index | 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. | 3 months after the start of treatment |
| Global Perceived Effect of Treatment at 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. | 3 months after the start of treatment |
| Global Perceived Effect of Treatment at 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. | 1 month after the start of treatment |
| Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale | 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. | 1 month from the start of treatment |
| Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale | 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. | 3 months after the start of treatment |
| Proceeded to Surgery Within Year of Enrollment | This is a measure of participants that proceeded to surgery within a year of enrollment | Measured within the year of enrollment in the study |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive real gabapentin and a placebo injection as treatment.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months from the start of treatment |
|
|
|
| Primary | Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month from the start of treatment |
|
|
|
| Primary | Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months from the start of treatment |
|
|
|
| Secondary | Average Back Pain at 1 Month Measured Using the Numeric Pain Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month fromt he start of treatment |
|
|
|
| Secondary | Average Back Pain at 3 Months Measured Using the Numeric Pain Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months from the start of treatment |
|
|
|
| Secondary | Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month after the start of treatment |
|
|
|
| Secondary | Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index | 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. | Posted | Mean | Standard Deviation | participants | 3 months after the start of treatment |
|
|
|
| Secondary | Global Perceived Effect of Treatment at 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. | Posted | Count of Participants | Participants | 3 months after the start of treatment |
|
|
|
| Secondary | Global Perceived Effect of Treatment at 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. | Posted | Count of Participants | Participants | 1 month after the start of treatment |
|
|
|
| Secondary | Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month from the start of treatment |
|
|
|
| Secondary | Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months after the start of treatment |
|
|
|
| Secondary | Proceeded to Surgery Within Year of Enrollment | This is a measure of participants that proceeded to surgery within a year of enrollment | 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. | Posted | Count of Participants | Participants | Measured within the year of enrollment in the study |
|
|
|
| 15 |
| 73 |
| 24 |
| 73 |
| EG001 | Gabapentin | Titration of gabapentin to effect Sham epidural steroid injection: Injection of saline into the back muscles Gabapentin: Titration of gabapentin to effect | 19 | 72 | 26 | 72 |
|
| Fever or infection | Infections and infestations | Those who experienced fever or infection after epidural steroid injection or intramuscular placebo injection. |
|
| Fall | Injury, poisoning and procedural complications | Fall after procedure |
|
| Vasovagal | Cardiac disorders |
|
| Coginitve | Nervous system disorders | Decrease cognition |
|
| Headache | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Swelling | Immune system disorders |
|
| Ataxia | Nervous system disorders | Systematic Assessment |
|
| Muscle Twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Weight Gain | Metabolism and nutrition disorders | Systematic Assessment |
|
| Sedation Fatigue | Nervous system disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |