Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT02013427
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2013-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
BRAIN MECHANISMS FOR CLINICAL PLACEBO IN CHRONIC PAIN: A Partially-Blind Randomized Clinical Trial of Placebo and Chronic Back Pain
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01AT007987-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |