Chronic Low Back Pain | Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial
Chronic Low Back Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - History of low back pain for a minimum of 6 months 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. - Male or female, age greater than18 years, with no racial/ethnic restrictions. - Must have a Visual Analog Scale (VAS) pain score >50 mm (of 100 mm maximum) at the baseline visit (for which 0mm = no pain, and 100 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. 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 II score of >28. - 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. - Regular use of low dose aspirin. - Current use of recreational drugs or history of alcohol or drug abuse. - Any change in medication for back pain in the last 30 days. - 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). Prohibited Medications: - Therapeutic doses of antidepressant medications (i.e., tricyclic depressants, SSRIs, SNRIs; low doses used for sleep may be allowed). - Oral iron supplementation unless approved by the investigator.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Low Back Pain
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:NaproxenTake one 500mg naproxen capsule twice a day.
Drug:PlaceboTake one placebo capsule twice a day.
Drug:OmeprazoleTake one 20mg omeprazole capsule twice a day.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ObservationalSubjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study. This arm is not blinded, as both study staff and participants will be aware that they are not receiving a study treatment.
Subjects randomized to this arm will be asked to discontinue their current pain medications and take one 500mg naproxen capsule and one 40mg omeprazole capsule twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment).
Placebo OnlySubjects randomized to this arm will be asked to discontinue their current pain medications and take two placebo capsules twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment).
Start Date: October 2014
Completed Date: May 2019
Phase: Phase 4
Primary Outcome: VAS pain scale
Study sponsors, principal investigator, and references
Principal Investigator: Apkar Apkarian, PhD
Lead Sponsor: Northwestern University
Collaborator: National Center for Complementary and Integrative Health (NCCIH)