Placebo In Chronic Back Pain (Phase 2)

• Status: Unknown status
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apkar Apkarian
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); National Institutes of Health (NIH)
• Treatments: Naproxen; Omeprazole

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