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Comparison of Gabapentin and Pregabalin for Radicular Pain

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ClinicalTrials.gov Identifier: NCT02064790
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Diana Sodiq, Emory University

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.


Condition or disease
Radicular; Neuropathic, Lumbar, Lumbosacral Radicular; Neuropathic, Cervical

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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Gabapentin and Pregabalin for Cervical and Lumbar Radicular Pain
Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Group G - receiving gabapentin
Receiving gabapentin as standard of care. No intervention
Group P - receiving pregabalin
Receiving pregabalin as standard of care No intervention
Group Z - no neuropathic agent
Receiving only conservative treatment No drug treatment No intervention



Primary Outcome Measures :
  1. Pain reduction with Visual Analogue Scale [ 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.



Secondary Outcome Measures :
  1. To compare the efficacy of each of the two neuropathic agents to the other in treatment of cervical or lumbar radiculopathy [ 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



Other Outcome Measures:
  1. To determine the rate of compliance and reported side effects related to the neuropathic agent used. [ 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064790


Locations
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United States, Georgia
Emory Orthopaedics and Spine Center
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Diana Sodiq, D.O. Emory University

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Responsible Party: Diana Sodiq, Assistant Professor of Orthopaedics, Emory University
ClinicalTrials.gov Identifier: NCT02064790     History of Changes
Other Study ID Numbers: IRB00069871
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016

Keywords provided by Diana Sodiq, Emory University:
Gabapentin
Pregabalin
Lyrica
Neurontin
lumbar
cervical

Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Depressants
Radiculopathy
Neuromuscular Diseases
Pregabalin
Gabapentin
Analgesics
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents