Failed Back Surgery Syndrome, Herniated Disc, Neuropathy; Radicular, Lumbar, Lumbosacral, Spinal Stenosis
Conditions
Keywords
Pregabalin, Radicular pain, Failed back surgery, Of greater than 3 months duration
Brief summary
The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.
Detailed description
Although the efficacy of pregabalin has been demonstrated in several pain states and it is approved by the FDA for use in post herpetic neuralgia, diabetic neuropathy and fibromyalgia there are few studies of its efficacy in patients with radicular pain from herniated disc, spinal stenosis or failed back surgery syndrome. This study was conducted to evaluate the efficacy of pregabalin in these pain states.
Interventions
DRUGPregabalin
One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
DRUGSugar Pill
One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with pain in dermatomal distribution, in either cervical or lumbar region. 2. History of pain for more than 3 months. 3. History of herniated disc, spinal stenosis or failed back surgery. 4. A series of epidural steroid injections within the past 6 months. 5. Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia, allodynia, dysesthesia) in the affected dermatomes. 6. Patients must be cognitively capable of completing the pain questionnaires.
Exclusion criteria
1. Patients below 18 or over 65 years of age. 2. Patients with mostly axial spinal pain. 3. Presence of significant motor deficits, and /or bowel and/or bladder dysfunction. 4. Workmen's compensation or disability issues. 5. Patients with chronic depression and on depression medications. 6. Addiction and/or substance abuse issues. 7. Patients using gabapentin or failure to respond to previous gabapentin use. 8. Patients with known peripheral neuropathy (e.g. DPN, PHN etc.). 9. Known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and wheezing). 10. History of angioedema with pregabalin use. 11. Patients with known renal insufficiency, diabetes, congestive heart failure, cardiac conduction abnormalities, and/or thrombocytopenia. 12. Patients using ACE-inhibitors and thiazolidinedione antidiabetic agents (Avandia®, Actos®). 13. Pregnant patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores (NRS) at 3-weeks | 3 weeks | Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment. . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Global Impression of Change at 3 Weeks | 3 weeks | Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below: 1. Very Much Improved 2. Much Improved 3. Minimally Improved 4. No Change 5. Minimally Worse 6. Much Worse 7. Very Much Worse |
| Oswestry Disability Questionnaires | 3 weeks | Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the percent disability. There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.
Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks. | 20 |
| Sugar Pill One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.
Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks. | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 6 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Pregabalin | Sugar Pill | 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 | 20 Participants | 19 Participants | 39 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 10.17 | 44 years STANDARD_DEVIATION 13.38 | 45 years STANDARD_DEVIATION 11.78 |
| Pain Score (Numeric Rating Scale , 0-10) | 6.5 units on a scale | 6 units on a scale | 6 units on a scale |
| Sex: Female, Male Female | 11 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 1 / 20 | 2 / 19 |
Outcome results
Primary
Pain Scores (NRS) at 3-weeks
Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment. .
Time frame: 3 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin | Pain Scores (NRS) at 3-weeks | 6 units on a scale |
| Sugar Pill | Pain Scores (NRS) at 3-weeks | 3 units on a scale |
p-value: 0.27999% CI: [-6, 3]Wilcoxon (Mann-Whitney)
Secondary
Oswestry Disability Questionnaires
Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the percent disability. There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks.
Time frame: 3 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin | Oswestry Disability Questionnaires | 41 percent disability |
| Sugar Pill | Oswestry Disability Questionnaires | 20 percent disability |
p-value: 0.13999% CI: [-42, 16]Wilcoxon (Mann-Whitney)
Secondary
Patient's Global Impression of Change at 3 Weeks
Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below: 1. Very Much Improved 2. Much Improved 3. Minimally Improved 4. No Change 5. Minimally Worse 6. Much Worse 7. Very Much Worse
Time frame: 3 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin | Patient's Global Impression of Change at 3 Weeks | 3.5 units on a scale |
| Sugar Pill | Patient's Global Impression of Change at 3 Weeks | 3 units on a scale |
p-value: 0.28299% CI: [-2, 1]Wilcoxon (Mann-Whitney)