Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329, United States
NCT Number: NCT02064790
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.
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Notify Me18 year and older
All sexes
Observational
Atlanta, Georgia, 30329, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 8 weeks
Specific Aim 1: To determine the efficacy of addition of gabapentin or pregabalin to conservative management for pain reduction in patients with cervical or lumbar radiculopathy.
Hypothesis 1: There is a significant improvement of pain level with addition of one of the neuropathic agents for patients with radiculopathy compared to patients who are treated without them.
Time frame: 8 weeks
Outcome measures below will be used.
Oswestry Low Back Pain Disability Questionnaire (ODO) Neck Disability Index (NDI) Usage/Reduction of non-neuropathic pain meds at each interval Side effects of medications
Time frame: 8 weeks
Hypothesis:
There will be a less than 15% discontinuation rate secondary to side effects in either of the two neuropathic agents.
Emory University
Other
Comparison of Gabapentin and Pregabalin for Cervical and Lumbar Radicular Pain
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