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NCT Number: NCT02064790

Comparison of Gabapentin and Pregabalin for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Comparison of Gabapentin and Pregabalin for Cervical and Lumbar Radicular Pain

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 17, 2014
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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