Sciatica, Radiculopathy
Conditions
Keywords
low back pain, radiculopathy, injection
Brief 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. 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.
Interventions
PROCEDUREepidural steroid injection
Injection of steroids and local anesthetic into the epidural space
PROCEDURESham epidural steroid injection
Injection of saline into the back muscles
DRUGGabapentin
Titration of gabapentin to effect
Titration of placebo gabapentin
Sponsors
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
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Perceived Effect of Treatment at 3 Months After the Start of Treatment | 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. |
| Global Perceived Effect of Treatment at 1 Month After the Start of Treatment | 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. |
| Average Back Pain at 1 Month Measured Using the Numeric Pain Scale | 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. |
| Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale | 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. |
| Proceeded to Surgery Within Year of Enrollment | Measured within the year of enrollment in the study | This is a measure of participants that proceeded to surgery within a year of enrollment |
| Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale | 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. |
| Average Back Pain at 3 Months Measured Using the Numeric Pain Scale | 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. |
| Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index | 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. |
| Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 73 |
| Gabapentin Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive real gabapentin and a placebo injection as treatment. | 72 |
| Total | 145 |
Baseline characteristics
| Characteristic | Epidural Steriod Injections | Gabapentin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 72 Participants | 145 Participants |
| Age, Continuous | 43.8 years STANDARD_DEVIATION 14 | 41.7 years STANDARD_DEVIATION 11.9 | 42.7 years STANDARD_DEVIATION 13.01 |
| Region of Enrollment Germany | 6 participants | 5 participants | 11 participants |
| Region of Enrollment United States | 67 participants | 67 participants | 134 participants |
| Sex: Female, Male Female | 25 Participants | 13 Participants | 38 Participants |
| Sex: Female, Male Male | 48 Participants | 59 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 73 | 26 / 72 |
| serious Total, serious adverse events | 15 / 73 | 19 / 72 |
Outcome results
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.
Time frame: 1 month after the start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Steroid Injection | Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale | 3.3 units on a scale | Standard Deviation 2.6 |
| Gabapentin | Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale | 3.7 units on a scale | Standard Deviation 2.6 |
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.
Time frame: 3 months from the start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Steroid Injection | Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale | 3.7 units on a scale | Standard Deviation 2.8 |
| Gabapentin | Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale | 3.4 units on a scale | Standard Deviation 2.7 |
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.
Time frame: 1 month from the start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Steroid Injection | Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale | 4.9 units on a scale | Standard Deviation 3.1 |
| Gabapentin | Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale | 5.8 units on a scale | Standard Deviation 3 |
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.
Time frame: 3 months from the start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Steroid Injection | Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale | 5.2 units on a scale | Standard Deviation 3.4 |
| Gabapentin | Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale | 5.5 units on a scale | Standard Deviation 3.4 |
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.
Time frame: 1 month fromt he start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Steroid Injection | Average Back Pain at 1 Month Measured Using the Numeric Pain Scale | 3.5 units on a scale | Standard Deviation 2.6 |
| Gabapentin | Average Back Pain at 1 Month Measured Using the Numeric Pain Scale | 3.6 units on a scale | Standard Deviation 2.6 |
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.
Time frame: 3 months from the start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Steroid Injection | Average Back Pain at 3 Months Measured Using the Numeric Pain Scale | 3.9 units on a scale | Standard Deviation 2.7 |
| Gabapentin | Average Back Pain at 3 Months Measured Using the Numeric Pain Scale | 3.7 units on a scale | Standard Deviation 2.5 |
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.
Time frame: 1 month after the start of treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Epidural Steroid Injection | Global Perceived Effect of Treatment at 1 Month After the Start of Treatment | Yes | 48 Participants |
| Epidural Steroid Injection | Global Perceived Effect of Treatment at 1 Month After the Start of Treatment | No | 25 Participants |
| Gabapentin | Global Perceived Effect of Treatment at 1 Month After the Start of Treatment | Yes | 33 Participants |
| Gabapentin | Global Perceived Effect of Treatment at 1 Month After the Start of Treatment | No | 39 Participants |
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.
Time frame: 3 months after the start of treatment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Epidural Steroid Injection | Global Perceived Effect of Treatment at 3 Months After the Start of Treatment | Yes | 27 Participants |
| Epidural Steroid Injection | Global Perceived Effect of Treatment at 3 Months After the Start of Treatment | No | 46 Participants |
| Gabapentin | Global Perceived Effect of Treatment at 3 Months After the Start of Treatment | Yes | 21 Participants |
| Gabapentin | Global Perceived Effect of Treatment at 3 Months After the Start of Treatment | No | 51 Participants |
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.
Time frame: 1 month after the start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Steroid Injection | Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index | 32.6 units on a scale | Standard Deviation 18.3 |
| Gabapentin | Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index | 29.6 units on a scale | Standard Deviation 16 |
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.
Time frame: 3 months after the start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Steroid Injection | Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index | 33.6 participants | Standard Deviation 19.4 |
| Gabapentin | Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index | 29.6 participants | Standard Deviation 16.3 |
Secondary
Proceeded to Surgery Within Year of Enrollment
This is a measure of participants that proceeded to surgery within a year of enrollment
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Steroid Injection | Proceeded to Surgery Within Year of Enrollment | 9 Participants |
| Gabapentin | Proceeded to Surgery Within Year of Enrollment | 10 Participants |
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.
Time frame: 1 month from the start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Steroid Injection | Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale | 5.1 units on a scale | Standard Deviation 2.9 |
| Gabapentin | Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale | 5.4 units on a scale | Standard Deviation 3.2 |
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.
Time frame: 3 months after the start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Steroid Injection | Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale | 5.6 units on a scale | Standard Deviation 3.2 |
| Gabapentin | Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale | 5.6 units on a scale | Standard Deviation 3.1 |