Comparison of Gabapentin and Pregabalin for Radicular Pain

Radicular; Neuropathic, Lumbar, Lumbosacral Clinical Trial

Official title:

Comparison of Gabapentin and Pregabalin for Cervical and Lumbar Radicular Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064790
• Other study ID #: IRB00069871
• Status: Completed
• Phase: N/A
• First received: February 14, 2014
• Last updated: March 8, 2016
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Radicular; Neuropathic, Cervical
• Radicular; Neuropathic, Lumbar, Lumbosacral
• Radiculopathy

Locations

Country	Name	City	State
United States	Emory Orthopaedics and Spine Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	8 weeks	No
Primary	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.	8 weeks	No
Secondary	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	8 weeks	No