SciaticaNCT01495923
Steroids Versus Gabapentin
A study testing epidural steroid injection and Gabapentin in people with Sciatica and Radiculopathy, run by Johns Hopkins University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 to 100 years
- Conditions the study is for
- Sciatica, Radiculopathy
- What is being tested?
- epidural steroid injection and Gabapentin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
- Numerical Rating Scale leg pain score > 4 (or if 3/10, greater or equal to back pain)
- MRI evidence of spinal pathology consistent with symptoms
Who cannot join
- Untreated coagulopathy
- Previous spine surgery
- No MRI study
- Leg pain > 4 years duration Epidural steroid injection within past 3 years Cauda equina syndrome Previous failed trials with gabapentin or pregabalin Allergic reactions to gabapentin or pregabalin Referrals from surgery for diagnostic injections for surgical evaluation Serious medical or psychiatric that condition that might preclude optimal outcome or interfere with participation, such as the need for uninterrupted anticoagulation.
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins
Baltimore, Maryland, 21205
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Naval Hospital-San Diego
San Diego, California, 92134
About this study
Official title: Randomized, Double-blind, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Gabapentin in Patients With Lumbosacral Radiculopathy
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.
Read the detailed description
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.
- Conditions
- Sciatica, Radiculopathy
- Being tested
- epidural steroid injection, Sham epidural steroid injection, Gabapentin, Placebo gabapentin
- Keywords
- low back pain, radiculopathy, injection
- Medical subject headings
- Sciatica, Radiculopathy, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural steroid injectionProcedure or surgery
Injection of steroids and local anesthetic into the epidural space
Sham epidural steroid injectionProcedure or surgery
Injection of saline into the back muscles
GabapentinDrug
Titration of gabapentin to effect
Placebo gabapentinDrug
Titration of placebo gabapentin
| Study group | Role | What they receive |
|---|---|---|
| Epidural steroids | Experimental | Injection of steroids into the epidural space Receives: Procedure: epidural steroid injection; Drug: Placebo gabapentin |
| Gabapentin | Active comparator | Titration of gabapentin to effect Receives: Procedure: Sham epidural steroid injection; Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months from the start of treatment
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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: Measured within the year of enrollment in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SciaticaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, Brooke Army Medical Center, Landstuhl Regional Medical Center, Washington D.C. Veterans Affairs Medical Center, United States Naval Medical Center, San Diego, Case Western Reserve University, Milton S. Hershey Medical Center
- Responsible party
- Principal investigator, Steven P. Cohen, Johns Hopkins University
- Investigators
- Steven P Cohen, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495923
- Sponsor's protocol ID
- NA_00047152
- Status last verified
- Feb 2017
- First submitted
- 15 Dec 2011
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25883095
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Gabapentin in Patients With Lumbosacral Radiculopathy
- ClinicalTrials.gov ID
- NCT01495923
- Acronym / sponsor ID
- NA_00047152
- Conditions
- Sciatica, Radiculopathy
- Keywords
- low back pain, radiculopathy, injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, Brooke Army Medical Center, Landstuhl Regional Medical Center, Washington D.C. Veterans Affairs Medical Center, United States Naval Medical Center, San Diego, Case Western Reserve University, Milton S. Hershey Medical Center
- Study start
- Dec 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 20 Dec 2011 (estimated)
- Results
- Posted 11 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural steroids | Experimental | Procedure: epidural steroid injection, Drug: Placebo gabapentinInjection of steroids into the epidural space |
| Gabapentin | Active comparator | Procedure: Sham epidural steroid injection, Drug: GabapentinTitration of gabapentin to effect |
Who may qualify
- Ages
- 17 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
- Numerical Rating Scale leg pain score > 4 (or if 3/10, greater or equal to back pain)
- MRI evidence of spinal pathology consistent with symptoms
Key exclusion criteria (5 listed)
- Untreated coagulopathy
- Previous spine surgery
- No MRI study
- Leg pain > 4 years duration Epidural steroid injection within past 3 years Cauda equina syndrome Previous failed trials with gabapentin or pregabalin Allergic reactions to gabapentin or pregabalin Referrals from surgery for diagnostic injections for surgical evaluation Serious medical or psychiatric that condition that might preclude optimal outcome or interfere with participation, such as the need for uninterrupted anticoagulation.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural steroid injectionInjection of steroids and local anesthetic into the epidural space | Procedure or surgery | Epidural steroids |
| Sham epidural steroid injectionInjection of saline into the back muscles | Procedure or surgery | Gabapentin |
| GabapentinTitration of gabapentin to effect | Drug | Gabapentin |
| Placebo gabapentinTitration of placebo gabapentin | Drug | Epidural steroids |
Primary outcome
Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale
Time frame: 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.
Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale
Time frame: 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.
Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale
Time frame: 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.
Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale
Time frame: 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.
9 secondary outcomes
Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
Time frame: 1 month fromt he start of treatment
Average Back Pain at 3 Months Measured Using the Numeric Pain Scale
Time frame: 3 months from the start of treatment
Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index
Time frame: 1 month after the start of treatment
Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index
Time frame: 3 months after the start of treatment
Global Perceived Effect of Treatment at 3 Months After the Start of Treatment
Time frame: 3 months after the start of treatment
Global Perceived Effect of Treatment at 1 Month After the Start of Treatment
Time frame: 1 month after the start of treatment
Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale
Time frame: 1 month from the start of treatment
Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale
Time frame: 3 months after the start of treatment
Proceeded to Surgery Within Year of Enrollment
Time frame: Measured within the year of enrollment in the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25883095Cohen 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven P Cohen, MD principal investigator
Walter Reed Army Institute of Research (WRAIR)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural steroid injection and Gabapentin in people with Sciatica and Radiculopathy, run by Johns Hopkins University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale (time frame: 1 month after the start of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01495923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.