Effect of L-dopa In Subacute Back Pain Population
Condition: Sub-acute Back Pain
MeSH terms: Back Pain
Intervention: Naproxen; Carbidopa/Levodopa; Placebo
Intervention description: Take one 250mg naproxen tablet three times a day for 12 weeks.; 12.5mg/50mg Carbidopa/Levodopa, administered orally as capsules, will be titrated up to TID over one week and then continued at that level for 4 weeks. If at the end of this initial 4 week period the participant has "responded," the subject will be maintained on that dose for the duration of the treatment period (12 weeks total). If there has not been a response, the dose will be increased to 25mg/100mg Carbidopa/Levodopa TID for the following 4 weeks at which time the pain status will be re-evaluated. If a response has occurred, that dose will be maintained in a blinded manner for the following 4 weeks of treatment; if not, further dose-titration will occur to 50mg/200mg Carbidopa/Levodopa TID for the final 4 weeks. If a subject experiences an AE at higher doses, then the subject will be given the next lower dose that s/he was able to tolerate and then be maintained on that dose for the remainder of the 12 week dosing period.; Take two placebo capsules three times a day for 12 weeks.
Intervention MeSH terms: Naproxen; Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Subacute; Back; Pain; Brain; MRI

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).
    

Eligibility criteria:

        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
             antidepressants, SSRIs, SNRIs; low doses used only in the evening for sleep will be
             allowed if dose is not changed)

          -  Current use of recreational drugs or recent history of alcohol abuse (pattern of
             drinking having social, financial or physical consequences) or drug abuse

          -  Any change in medication for back pain in the last 30 days

          -  High dose opioid prophylaxis, defined as > 50mg morphine equivalent/day

          -  Use of MAOIs, currently or within the past 2 weeks

          -  Prior use of Levodopa

          -  Use of any of the following drugs: bromocryptine, linezolid, metoclopramide,
             phenothiazines,promethazine/codeine, isoniazid, rifampin, pyrazinamide

          -  Oral iron supplementation

          -  Contraindications to use of study product, based on any of the following:

               -  Hypersensitivity to Carbidopa/Levodopa or other constituents of the
                  Carbidopa/Levodopa capsules

               -  Hypersensitivity to lactose or other constituents of the placebo capsules

               -  Hypersensitivity to Naproxen or other constituents of the Naproxen capsules

               -  Hypersensitivity to Acetaminophen or other constituents of the Acetaminophen
                  tablets

          -  Currently taking Levodopa or dopaminergic drugs

          -  Involvement in litigation regarding their back pain or having a disability claim or
             receiving workman's compensation or seeking either as a result of their low back pain

          -  In the judgment of the investigator, unable or unwilling to follow protocol and
             instructions

          -  Intra-axial implants (e.g. spinal cord stimulators or pumps)

          -  All exclusion criteria for MR safety: any metallic implants, pacemaker, brain or skull
             abnormalities, tattoos on large body parts, and claustrophobia

          -  Pregnancy or inability to use an effective method of birth control in sexually active
             men and women while taking the study drug and for one week thereafter. Barrier
             contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (IUD's),
             hormonal contraceptives, oral contraceptive pills, surgical sterilization, and
             complete abstinence are examples of effective methods of contraception.

          -  Following laboratory abnormalities: liver function tests (SGOT/SGPT) greater than
             twice the upper limit of normal; unexplained anemia (Hgb <9 g/dL); evidence of renal
             insufficiency (creatinine >upper limit of normal) or any other abnormality that the
             principal investigator feels puts the subject at risk during the study

          -  History of chronic opioid use for pain management.

          -  Any medical condition that in the investigator's judgment may prevent the individual
             from completing the study or put the individual at undue risk