Clinical trial NCT02064790: Comparison of Gabapentin and Pregabalin for Radicular Pain
Official title: Comparison of Gabapentin and Pregabalin for Cervical and Lumbar Radicular Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radicular; Neuropathic, Lumbar, Lumbosacral
Radicular; Neuropathic, Cervical
Keywords: Gabapentin
Pregabalin
Lyrica
Neurontin
lumbar
cervical
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain reduction with Visual Analogue Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: To compare the efficacy of each of the two neuropathic agents to the other in treatment of cervical or lumbar radiculopathy
timeFrame: 8 weeks
Other outcomes:
measure: To determine the rate of compliance and reported side effects related to the neuropathic agent used.
timeFrame: 8 weeks
Locations:
city: Atlanta
country: United States
facility: Emory Orthopaedics and Spine Center
state: Georgia
Study officials:
affiliation: Emory University
name: Diana Sodiq, D.O.
role: PRINCIPAL_INVESTIGATOR
References: