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Effect of L-dopa In Subacute Back Pain Population

CompletedPhase 4NCT01951105
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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).

Study details

Official title
Corticostriatal Plasticity in the Transition to Chronic Pain: Effect of L-dopa
Conditions
  • Sub-acute Back Pain
Interventions
Sponsor
Northwestern University
Collaborators
National Institutes of Health (NIH); National Institute of Dental and Craniofacial Research (NIDCR)
Start date
2015-02-24
Primary completion
2017-09-25
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Male or female, over the age of 18 years, (no racial/ethnic restrictions) * Must have a history of low back pain for a minimum of 4 weeks and a maximum of 12 weeks with signs and symptoms of radiculopathy: positive straight leg raising test with dermatomal radiation and/or myotomal weakness and/or reflex asymmetry; pain must radiate into buttock or below * Must have a high risk phenotype for chronification of back pain (evaluated at baseline T1-MRI, DTI-MRI, and fMRI scans) * Must have an average pain score over a 5 day period (average of \~15 measures on smartphone app) immediately preceding the baseline visit of ≥ 5 (on a 0-10 NRS) at the baseline visit * Must be willing to read and able to understand instructions as well as PROs * Must be in generally stable health Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate Exclusion Criteria: * Previous (distinct) episodes of back pain onset (more than 3 distinct episodes of back pain lasting for a total of more than 4 weeks) in the previous year * Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, chronic spinal stenosis, prior back surgery and history of tumor of the spine * Low back pain associated with any systemic signs or symptoms, e.g., fever, chills * Other comorbid chronic pain conditions such as fibromyalgia or neuropathic pain secondary to diabetes or post-herpes zoster * Chronic neurologic conditions, including Parkinson's disease, Alzheimer's disease, and other conditions associated with dementia * Significant other medical disease such as congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy * Diabetes Type I or Type II * History of glaucoma or narrow angle glaucoma * Presence of undiagnosed skin lesions or history of melanoma * Presence of severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease * History of myocardial infarction with residual cardiac arrhythmia * History of gastrointestinal bleeding or peptic ulcer * Diagnosis of current depression (assessed via BDI, total \> 28 are excluded) or psychiatric disorder requiring treatment, or such a diagnosis in the previous 6 months * Use of therapeutic doses of antidepressant medications (i.e., tricyclic antidep…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01951105