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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: Completed NA study, sponsored by University of Colorado, Boulder.
NCT03294148 is a NA study that has completed, run by University of Colorado, Boulder. The registered enrollment target is 151 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
1-week average pain intensity, 0 - 10 numerical rating scale, where a higher score indicates more pain.
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 |
What the finished NCT03294148 record still lists
NCT03294148 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03294148's enrollment target sits among peer trials
151 661st of 2000 higher than 1,340 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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