Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Northwestern University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Apkar Apkarian, Northwestern University
ClinicalTrials.gov Identifier:
NCT02013427
First received: December 9, 2013
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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 double-blind clinical trial.


Condition Intervention Phase
Chronic Low Back Pain
Drug: Naproxen
Drug: Placebo
Drug: Omeprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BRAIN MECHANISMS FOR CLINICAL PLACEBO IN CHRONIC PAIN: A Double-Blind Randomized Clinical Trial of Placebo and Chronic Back Pain

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • VAS pain scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: November 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Observational
Subjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study.
Active Comparator: 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.
Drug: Naproxen
Take one 500mg naproxen capsule twice a day.
Other Names:
  • Aleve
  • Anaprox
  • Antalgin
  • Apranax
  • Feminax Ultra
  • Flanax
  • Inza
  • Midol Extended Relief
  • Nalgesin
  • Naposin
  • Naprelan
  • Naprogesic
  • Naprosyn
  • Narocin
  • Proxen
  • Soproxen
  • Synflex
  • Xenobid
Drug: Omeprazole
Take one 40mg omeprazole capsule twice a day.
Other Names:
  • Prilosec
  • losepine
Placebo Comparator: Placebo Only
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.
Drug: Placebo
Take one placebo capsule twice a day.
Other Name: Sugar Pill

Detailed Description:

Below is a detailed description of what the study would entail (in other words, what would be expected during each visit for the duration of the study).

  • Visit 1 (week -2): Pre-treatment screening (180 min). Participants will complete the informed consent process and are evaluated for inclusion/exclusion criteria. A medical/pain history and physical examination will be completed and participants will be asked to assess current back pain intensity on a VAS scale (0-100mm, no pain to worst possible pain). Participants complete questionnaires and return within 2 weeks for baseline MR imaging scans. Blood will be drawn for a baseline screen to obtain a complete blood count, chemistry panel, and liver function tests. Participants will be asked to discontinue their current pain medications 14 days (2 weeks) prior to their baseline visit and take only acetaminophen rescue medication during this time.
  • Visit 2 (week 0): Baseline visit (60-90 min). Participants complete the VAS pain scale, and if their pain is above a designated level and no changes in clinical status are reported, they complete a battery of questionnaires and undergo fMRI procedures (anatomical and functional scans). Participants will then be randomized to one of three groups: active treatment, or placebo, or no-treatment groups; this is done in a blind fashion, with medication dispensed in sufficient quantities until the next visit. The placebo group will receive two placebo capsule bid, and the standard of care group will receive one naproxen capsule (500mg) and one esomeprazole capsule (20 mg) bid for the treatment period. The no treatment group and all participants will receive rescue medication (n=20).
  • Visit 3 (week 2): End of Treatment Period 1/Washout (60-90 min). All procedures will be performed as described for Visit 2. A set of questionnaires will be administered. Adherence will be assessed by pill counts, use of rescue medication documented, and participants will be queried about any side effects experienced. Only rescue medication will be dispensed, to all participants, as they will begin a one week washout of treatment.
  • Visit 4 (week 3): End of Washout/Beginning Treatment Period 2 (60-90 min). All procedures will be performed as described for Visit 3, plus the addition of brain scans. Adherence will be assessed by use of rescue medication documented, and participants will be queried about any side effects experienced. Study medication will be dispensed in sufficient quantities until the next visit. All participants remain with the same treatment assignment as in Period 1.
  • Visit 5 (week 5): End of Treatment Period 2/Washout 2 (60-90 min). All procedures will be performed as described for Visit 3, with the addition of post-treatment imaging scans. Adherence will be assessed by pill counts, use of rescue medication documented, and participants will be queried about any side effects experienced. Only rescue medication will be dispensed.
  • Visit 6 (week 6): End of Washout 2 (90 min). Participants will return to complete questionnaires but no imaging studies will be conducted. Use of rescue medication and side effects will be documented. Exit interviews will be conducted at this time.
  • Interim periods: During weeks in between visits, participant data will be tracked with the assistance of a smart phone/computer application designed for the study. Depending upon preference, the research staff will download an app onto participants' phones or give them a link to use on their computers; in the case that a participant does not have a smart phone or easy access to a computer/internet, the study will provide him/her with a smart phone that has the app already installed. Participants will be given a login and will be asked to use this application twice a day right after they take their medication. The app asks participants to rate the severity of their pain and their mood on a Likert scale, and probes them as to whether or not they took their medication.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013427

Contacts
Contact: Etienne Vachon-Presseau, PhD 312-503-3039 etienne.vachon-presseau@northwestern.edu
Contact: Sara E Berger, BA 312-503-1703 saraberger2015@u.northwestern.edu

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Etienne Vachon-Presseau, PhD    312-503-3039    etienne.vachon-presseau@northwestern.edu   
Contact: Sara E Berger, BA    312-503-1703    saraberger2015@u.northwestern.edu   
Principal Investigator: Apkar Apkarian, PhD         
Sub-Investigator: Todd B Parrish, PhD         
Sub-Investigator: Thomas J Schnitzer, MD, PhD         
Sub-Investigator: David Cella, PhD         
Sub-Investigator: Richard Gershon, PhD         
Sub-Investigator: David C Mohr, PhD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Apkar Apkarian, PhD Northwestern University Feinberg School of Medicine
  More Information

No publications provided

Responsible Party: Apkar Apkarian, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02013427     History of Changes
Other Study ID Numbers: STU00080585, R01AT007987-01A1
Study First Received: December 9, 2013
Last Updated: October 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:
chronic
back
pain
brain
MRI

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Omeprazole
Naproxen
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014