Effect of L-dopa In Subacute Back Pain Population
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ClinicalTrials.gov Identifier: NCT01951105 |
Recruitment Status :
Completed
First Posted : September 26, 2013
Results First Posted : September 25, 2019
Last Update Posted : September 25, 2019
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Sponsor:
Northwestern University
Collaborators:
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Apkar Apkarian, Northwestern University
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 17, 2013 | ||||||
First Posted Date ICMJE | September 26, 2013 | ||||||
Results First Submitted Date ICMJE | June 4, 2019 | ||||||
Results First Posted Date ICMJE | September 25, 2019 | ||||||
Last Update Posted Date | September 25, 2019 | ||||||
Actual Study Start Date ICMJE | February 24, 2015 | ||||||
Actual Primary Completion Date | September 25, 2017 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Number of Participants With 20% Reduction in Pain on the NRS Pain Intensity Scale [ Time Frame: 6 months ] Primary outcome is 20% reduction in pain intensity at p<0.1 based on pain ratings during 1 week prior to treatment and last week of study participation (at ~6months)
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Original Primary Outcome Measures ICMJE |
VAS pain scale [ Time Frame: 6 months ] | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Percent of Residual Pain Stratified by Gender for Individuals Receiving Treatment [ Time Frame: 6 months ] Residual pain is computed based on pain ratings from the week prior to treatment and last week of study participation (at ~6months)
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Effect of L-dopa In Subacute Back Pain Population | ||||||
Official Title ICMJE | Corticostriatal Plasticity in the Transition to Chronic Pain: Effect of L-dopa | ||||||
Brief Summary | This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) is associated with changes in blocking transition to chronic back pain (CBP). | ||||||
Detailed Description | The transition from acute low back pain to chronic low back pain has been shown to be a result of changes in brain circuitry. Learning mechanisms give rise to the transition from acute to chronic pain and render the pain to become more emotional. The aim of this study is to further explore the idea that persistent pain, following an inciting injury, leads to an aversive learning signal that reorganizes the brain into a chronic pain state. We hypothesize that blocking the emotional/motivational learning response triggered by peripheral nerve injury in a critical time window will decrease the probability of transition to chronic pain. The primary hypothesis to be tested in the study is that early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) should decrease related reorganization and block transition to chronic back pain (CBP). This will be done through a 6 month, double-blind, randomized, placebo-controlled, three-arm, parallel-group trial of the pharmacological treatment Carbidopa/Levodopa for individuals (N = 200) with sub-acute back pain (SBP). A baseline MRI scan will be used to determine each subject's pain type and group assignment. Individuals with recovering sub-acute back pain will be observed over 6 months. Individuals with a persisting sub-acute back pain will be randomized to receive either 12 weeks of Carbidopa/Levodopa plus naproxen or placebo plus naproxen. The main outcome measurements will be the results of MRI scans at the baseline and final visit, assessment of back pain by the NRS pain scale, as well as pain assessment through self-reported questionnaires. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Sub-acute Back Pain | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
72 | ||||||
Original Estimated Enrollment ICMJE |
150 | ||||||
Actual Study Completion Date ICMJE | September 25, 2017 | ||||||
Actual Primary Completion Date | September 25, 2017 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01951105 | ||||||
Other Study ID Numbers ICMJE | STU00081444 R01DE022746 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Apkar Apkarian, Northwestern University | ||||||
Study Sponsor ICMJE | Northwestern University | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Northwestern University | ||||||
Verification Date | September 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |