Comparison of Gabapentin and Pregabalin for Radicular Pain
Status: | Completed |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | April 2014 |
End Date: | December 2015 |
Comparison of Gabapentin and Pregabalin for Cervical and Lumbar Radicular Pain
Although some studies show improvement of pain and associated effects of pain with off-label
use of neuropathic agents for cervical or lumbar radiculopathy, there is limited published
evidence so far. We propose to complete a year-long prospective, observational study as a
pilot to recruit 400 patients within the year and follow their pain level, function, and QOL
measures for 16 weeks to determine whether it is feasible to continue studying this group in
the future. We expect that pain, function, and quality of life will be improved in the group
of patients who are given neuropathic agents as an adjunct to other conservative treatments
compared to the expected 65% of patients with similar symptoms who are treated
conservatively without neuropathic agents. We do not expect a statistically significant
difference between the two neuropathic agents.
Since these drugs are currently used off-label, there is limited empirical evidence
regarding which agent is more efficacious compared to the other, and since their use in
treating radicular pain is based mostly on anecdotal evidence so far, prescription of one or
the other of these agents has been based on likely compliance (medication needed twice a
day, three times a day) or whether or not the patients' insurance will pay for one or the
other. This study will be a first step to better assist practitioners in counselling their
patients on use of these medications in radiculopathy, examining rates of discontinuation
due to side effects and what effects these medications have on perceived pain, function and
quality of life.
use of neuropathic agents for cervical or lumbar radiculopathy, there is limited published
evidence so far. We propose to complete a year-long prospective, observational study as a
pilot to recruit 400 patients within the year and follow their pain level, function, and QOL
measures for 16 weeks to determine whether it is feasible to continue studying this group in
the future. We expect that pain, function, and quality of life will be improved in the group
of patients who are given neuropathic agents as an adjunct to other conservative treatments
compared to the expected 65% of patients with similar symptoms who are treated
conservatively without neuropathic agents. We do not expect a statistically significant
difference between the two neuropathic agents.
Since these drugs are currently used off-label, there is limited empirical evidence
regarding which agent is more efficacious compared to the other, and since their use in
treating radicular pain is based mostly on anecdotal evidence so far, prescription of one or
the other of these agents has been based on likely compliance (medication needed twice a
day, three times a day) or whether or not the patients' insurance will pay for one or the
other. This study will be a first step to better assist practitioners in counselling their
patients on use of these medications in radiculopathy, examining rates of discontinuation
due to side effects and what effects these medications have on perceived pain, function and
quality of life.
Inclusion Criteria:
- Cervical or lumbar radicular complaints with clinical diagnosis of radiculopathy or
sciatica
- Aged 18 years and older
- Able to provide informed consent either with or without a legally authorized
representative
- Patients with VAS> or = 4 (Visual Analog Pain score)
Exclusion Criteria:
- Under the age of 18
- Previously completed epidural injections within 3 weeks of the study
- Undergone cervical or lumbar surgery
- History of renal disease, metastatic disease to the spine, vertebral fractures
- Individuals with pending litigation, workers compensation claims or disability claims
- Unable to provide informed consent and no legally authorized representative is
available
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