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Placebo In Chronic Back Pain (Phase 2) (PICP2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02986334
Recruitment Status : Unknown
Verified December 2016 by Apkar Apkarian, Northwestern University.
Recruitment status was:  Recruiting
First Posted : December 8, 2016
Last Update Posted : December 8, 2016
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Apkar Apkarian, Northwestern University

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: Naproxen Drug: Omeprazole Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Brain Mechanisms For Clinical Placebo in Chronic Pain: A Randomized Clinical Trial of Placebo, Active Treatment, and No Treatment in Chronic Back Pain
Study Start Date : August 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
No Intervention: No Treatment Intervention
Observational Subjects 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.
Active Comparator: Active Treatment Intervention
Naproxen & Omeprazole 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).
Drug: Naproxen
Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening.
Other Names:
  • Aleve
  • Anaprox
  • Antalgin
  • Feminax Ultra
  • Flanax
  • Inza
  • Midol Extended Relief
  • Nalgesin
  • Naposin
  • Naprelan
  • Naprogesic
  • Naprosyn
  • Narocin
  • Proxen
  • Soproxen
  • Synflex
  • Xenobid

Drug: Omeprazole
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.
Other Names:
  • Prilosec
  • Iosepine

Placebo Comparator: Placebo Treatment Intervention
Subjects 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)
Drug: Placebo
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.
Other Name: Sugar Pill




Primary Outcome Measures :
  1. VAS pain scale [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986334


Contacts
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Contact: Taha B Abdullah, M.S. 312-451-8468 taha.abdullah1@northwestern.edu

Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Taha B Abdullah, M.S.    312-451-8468    taha.abdullah1@northwestern.edu   
Sponsors and Collaborators
Apkar Apkarian
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Apkar V Apkarian, PhD Northwestern University Feinberg School of Medicine

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Responsible Party: Apkar Apkarian, Professor in Physiology, Anesthesiology and Physical Medicine and Rehabilitation, Northwestern University
ClinicalTrials.gov Identifier: NCT02986334    
Other Study ID Numbers: STU00080585 (Phase 2)
5R01AT007987-03 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Apkar Apkarian, Northwestern University:
chronic
low back
back
pain
brain
MRI
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Naproxen
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors