Placebo In Chronic Back Pain (Phase 2)
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Naproxen; Omeprazole; Placebo
Intervention description: Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening.; Subjects enrolled in the active treatment arm will receive 20mg of Omeprazole prescribed twice daily, once in the morning and evening. Furthermore, subjects should take this one hour before a meal.; Subjects enrolled in the inactive treatment arm will receive two prescriptions, however, there are no active ingredients and are intended to look identical to the active treatment. Therefore, subjects will be instructed exactly the same way as if they were ingesting the active treatment.
Intervention MeSH terms: Naproxen; Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: chronic; low back; back; pain; brain; MRI

Summary:

      This study is designed to examine brain properties for placebo response in chronic back pain
      patients. The investigators have preliminary data indicating that, in blinded clinical trial
      studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can
      be subdivided into placebo responders and non-responders, and these differences are
      PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have clinical
      utility and that its properties can be studied by human brain imaging techniques. In Phase I
      of the study, the investigators seek to identify brain imaging parameters that predict the
      propensity for the placebo response in an independent CBP cohort. In Phase II, the
      investigators will evaluate the interaction between placebo response and medication treatment
      in individuals stratified as placebo responders versus non-responders. This research is
      designed to critically assess the neurobiology of placebo analgesia for chronic pain in a
      partially-blind clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of low back pain for a minimum of 6 months with or without signs and symptoms
             of radiculopathy

          -  Male or female, between the ages of 18 and 75 years, with no racial or ethnic
             restrictions

          -  Must have a Visual Analog Scale (VAS) pain score of 5 mm (of 10 mm maximum) at the
             screening visit (for which 0mm = no pain, and 10 mm = worst pain imaginable);

          -  Must be able to read and speak English and be willing to read and understand
             instructions as well as questionnaires;

          -  Must be in generally stable health;

          -  Must sign an informed consent document after a 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

          -  Must have, on average, 5/10 units (VAS scale) of pain over the course of a two-week
             period prior to visit 1; rounding up from 4.5/10 is permissible.

          -  Must be willing to complete daily smart phone/computer app ratings.

        Exclusion Criteria:

          -  Low back pain associated with any systemic signs or symptoms, e.g., fever, chills;

          -  Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
             fibromyalgia, history of tumor in the back;

          -  Other comorbid chronic pain or neurological conditions;

          -  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;

          -  Diagnosis of current depression or psychiatric disorder requiring treatment, or such a
             diagnosis in the previous 6 months;

          -  Beck Depression Inventory (BDI) Ia score greater or equal to 19 for two consecutive
             completions; if the first score meets this criteria, the participant must be re-tested
             before his/her next visit, but if the second score does not meet this criteria, the
             participant will be included and followed closely throughout the study

          -  Use of therapeutic doses of antidepressant medications (i.e., tricyclic depressants,
             SSRIs, SNRIs; low doses used for sleep may be allowed);

          -  Significant other medical disease such as unstable diabetes mellitus, congestive heart
             failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or
             malignancy;

          -  History of gastrointestinal ulcer during the past year;

          -  History of myocardial infarction in the past year;

          -  Uncontrolled hypertension;

          -  Renal insufficiency;

          -  Allergic to, or non-tolerant of, NSAIDs;

          -  History of aspirin-sensitive asthma;

          -  Current use of recreational drugs or history of alcohol or drug abuse;

          -  Any change in medication for back pain in the last 30 days only applicable for visit 1

          -  High dose opioid prophylaxis, as defined as > 50mg morphine equivalent/day;

          -  Any medical condition that in the investigator's judgment may prevent the individual
             from completing the study or put the individual at undue risk;

          -  In the judgment of the investigator, unable or unwilling to follow protocol and
             instructions;

          -  Evidence of poor treatment compliance, in the judgment of the investigator;

          -  Intra-axial implants (e.g. spinal cord stimulators or pumps);

          -  All exclusion criteria for MR safety: any metallic implants, brain or skull
             abnormalities, tattoos on large body parts, and claustrophobia;

          -  Pregnancy, or inability to use an effective form of contraception in women of
             child-bearing age;

          -  Diabetes (Type I or Type II);

          -  Lactose intolerance or sensitivity to lactose