Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial
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|ClinicalTrials.gov Identifier: NCT02013427|
Recruitment Status : Recruiting
First Posted : December 17, 2013
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Drug: Naproxen Drug: Placebo Drug: Omeprazole||Phase 4|
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 partially blind fashion (explained below), 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 active and placebo treatment groups are double-blinded, meaning that neither the participant nor the researchers will know which treatment participants are receiving (in part through the use of identical re-encapsulation of study agents). The no-treatment group allocation is not blind, as both participants and study staff will be aware that these participants are not receiving study agent. The no treatment group and all participants assigned to a treatment group will continue to 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||BRAIN MECHANISMS FOR CLINICAL PLACEBO IN CHRONIC PAIN: A Partially-Blind Randomized Clinical Trial of Placebo and Chronic Back Pain|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||May 2019|
No 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: 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).
Take one 500mg naproxen capsule twice a day.
Other Names:Drug: Omeprazole
Take one 20mg omeprazole capsule twice a day.
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. 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).
Take one placebo capsule twice a day.
Other Name: Sugar Pill
- VAS pain scale [ Time Frame: 6 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013427
|Contact: Etienne Vachon-Presseau, PhDemail@example.com|
|Contact: Sara E Berger, BAfirstname.lastname@example.org|
|United States, Illinois|
|Northwestern University Feinberg School of Medicine||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Etienne Vachon-Presseau, PhD 312-503-3039 email@example.com|
|Contact: Sara E Berger, BA 312-503-1703 firstname.lastname@example.org|
|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|
|Principal Investigator:||Apkar Apkarian, PhD||Northwestern University Feinberg School of Medicine|