An observational study in Radicular; Neuropathic, Lumbar, Lumbosacral and Radicular; Neuropathic, Cervical, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-09.
Sponsored by Emory University · Observational
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.
488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.
This study's enrollment of 6 is below the median of 93 across 98 observational studies indexed under Radiculopathy.
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Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
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Adult participants of both genders and all ethnicities will be invited to participate in this study as they present to Emory Orthopaedics and Spine Clinic and are diagnosed with and treated for cervical or lumbar radicular pain.
Exclusion Criteria:
Receiving gabapentin as standard of care. No intervention
Receiving pregabalin as standard of care No intervention
Receiving only conservative treatment No drug treatment No intervention
Pain reduction with Visual Analogue Scale
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
To compare the efficacy of each of the two neuropathic agents to the other in treatment of cervical or lumbar radiculopathy
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
To determine the rate of compliance and reported side effects related to the neuropathic agent used.
Hypothesis: There will be a less than 15% discontinuation rate secondary to side effects in either of the two neuropathic agents.
Time frame: 8 weeks
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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