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NCT03294148 · ClinicalTrials.gov registry record · NA
Mind-body Treatments for Chronic Back Pain
A NA study, sponsored by University of Colorado, Boulder.
- Completed
- Registry status
- NA
- Development phase
- 151
- Enrollment target
NCT03294148 is a NA study that has completed, run by University of Colorado, Boulder. The registered enrollment target is 151 participants.
The verdict
NCT03294148, a NA study, has completed, sponsored by University of Colorado, Boulder.
- COMPLETED
- Registry status
- NA
- Development phase
- 151 participants
- Enrollment target
Study Summary
Participants with chronic back pain will complete an online prescreen. They will then be randomized to one of two different studies: a placebo vs. waitlist study or a psychotherapy vs. waitlist study, with randomization stratified on pain intensity, age, gender, and opioid use. Participants will then complete an in-person eligibility session, and eligible participants will be scheduled for the baseline assessment session. Following the baseline assessment session, participants will then be randomized to the treatment group or the waitlist group (with a ratio of 2:1 treatment:waitlist), using a computer-generated random sequence. This scheme will result in three equally sized groups-placebo, psychotherapy, and waitlist-as the investigators will collapse data from the waitlist arms in the two studies for analyses. The investigators do not use a standard three-way randomization because the investigators do not want placebo participants to think they are in a control condition. Thus, the investigators constrain participant's expectations to either injection vs. waitlist or to psychotherapy vs. waitlist. The placebo treatment is a subcutaneous injection of saline into the back. Participants will know that the treatment is a placebo, i.e., it is an "open label" placebo. Psychotherapy (8 sessions) will be supervised by Alan Gordon and Howard Schubiner. Functional MRI brain imaging, self-reported clinical outcomes, and behavioral measures will be collected pre- and post-treatment. A brief follow-up survey will be sent at months 1, 2, 3, 6, and 12 after the final assessment session. These will provide longer term data about the trajectory and durability of patient improvement. Additionally, a group of healthy controls, with no history of back pain, will complete the baseline assessment. They will serve as a comparison group to probe whether the patterns of observed brain activity is specific to CBP patients.
Interventions
- OTHER Open-Label Placebo Treatment for Chronic Back Pain
- BEHAVIORAL Psychotherapy Treatment for Chronic Back Pain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2017-08-07 |
| Est. Completion | 2019-11-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03294148
The ClinicalTrials.gov registry entry for NCT03294148 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Boulder, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Open-Label Placebo Treatment for Chronic Back Pain is the first listed.
NCT03294148 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03294148 about?
NCT03294148 is a clinical study titled "Mind-body Treatments for Chronic Back Pain". Participants with chronic back pain will complete an online prescreen. They will then be randomized to one of two different studies: a placebo vs. waitlist study or a psychotherapy vs. waitlist study, with randomization stratified on pain intensity, age, gender, and opioid use. Participants will the...
What is the current status of trial NCT03294148?
This trial is currently completed. It is a NA study. The enrollment target is 151 participants. The study started on 2017-08-07. Estimated completion is 2019-11-26.
What interventions are being tested in trial NCT03294148?
The interventions under investigation include: Open-Label Placebo Treatment for Chronic Back Pain (OTHER), Psychotherapy Treatment for Chronic Back Pain (BEHAVIORAL).
Who is sponsoring clinical trial NCT03294148?
This trial is sponsored by University of Colorado, Boulder, which has 69 total clinical trials registered on ClinicalTrials.gov.
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