Radicular; Neuropathic, Lumbar, LumbosacralNCT02064790
Comparison of Gabapentin and Pregabalin for Radicular Pain
An observational study of Radicular; Neuropathic, Lumbar, Lumbosacral and Radicular; Neuropathic, Cervical, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radicular; Neuropathic, Lumbar, Lumbosacral, Radicular; Neuropathic, Cervical
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329
About this study
Official title: Comparison of Gabapentin and Pregabalin for Cervical and Lumbar 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.
- Keywords
- Gabapentin, Pregabalin, Lyrica, Neurontin, lumbar, cervical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radicular; Neuropathic, Lumbar, LumbosacralStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Sodiq, Emory University
- Investigators
- Diana Sodiq, D.O., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064790
- Sponsor's protocol ID
- IRB00069871
- Status last verified
- Mar 2016
- First submitted
- 14 Feb 2014
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gabapentin and Pregabalin for Cervical and Lumbar Radicular Pain
- ClinicalTrials.gov ID
- NCT02064790
- Acronym / sponsor ID
- IRB00069871
- Keywords
- Gabapentin, Pregabalin, Lyrica, Neurontin, lumbar, cervical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Sodiq, D.O. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radicular; Neuropathic, Lumbar, Lumbosacral and Radicular; Neuropathic, Cervical, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction with Visual Analogue Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.