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NCT03115359 · ClinicalTrials.gov registry record · NA
Strategies to Assist With Management of Pain
A NA study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- NA
- Development phase
- 770
- Enrollment target
NCT03115359 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 770 participants.
The verdict
NCT03115359, a NA study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- NA
- Development phase
- 770 participants
- Enrollment target
Study Summary
Chronic low back pain (CLBP) has no known effective treatment. While often treated with long-term opioid therapy, opioids do not work well for many patients and can cause serious side effects, including addiction, poorer mental health, and overdose death. Even when paired with a standard-of-care cognitive behavioral therapy (CBT), results are limited. Patients, families and clinicians are very interested in using alternative treatments for CLBP, especially complementary and integrative treatments such as mindfulness meditation (MM). MM helps train the mind to bring non-judgmental and accepting attention to present-moment experiences such as pain. MM offers an active and safe self-care approach to chronic pain that contrasts with the passive and potentially harmful nature of opioid treatment, and may prove more effective than CBT in helping improve health and well-being, and reduce reliance on opioids in adults with opioid-treated CLBP. Although this hypothesis is supported by early research, including a pilot study by the Principal Investigator, evidence on MM's effectiveness in this population is inconclusive, presenting a critical knowledge gap. With input from patients, family members, and clinicians, the Investigators have designed a study to address this gap and propose a clinical trial that will compare the effectiveness of MM to standard-of-care CBT in opioid-treated CLBP. Based on the existing research, it is hypothesized that MM training will lead to a larger reduction in pain intensity, increase in physical function, improvement in quality of life, and decrease in daily opioid dose, as compared to CBT training, with benefits of MM especially notable in adults with worse mood, anxiety or unhealthy opioid-use behaviors who often experience more severe symptoms of CLBP and less improvement in response to existing therapies. To test these hypotheses, 766 adults with opioid-treated CLBP will be randomly assigned into one of two 8-week treatment groups: MM (38
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy
- BEHAVIORAL Mindfulness Based Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 770 participants |
| Start Date | 2017-06-30 |
| Est. Completion | 2023-01-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03115359
The ClinicalTrials.gov registry entry for NCT03115359 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 770 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy is the first listed.
NCT03115359 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03115359 about?
NCT03115359 is a clinical study titled "Strategies to Assist With Management of Pain". Chronic low back pain (CLBP) has no known effective treatment. While often treated with long-term opioid therapy, opioids do not work well for many patients and can cause serious side effects, including addiction, poorer mental health, and overdose death. Even when paired with a standard-of-care cog...
What is the current status of trial NCT03115359?
This trial is currently completed. It is a NA study. The enrollment target is 770 participants. The study started on 2017-06-30. Estimated completion is 2023-01-15.
What interventions are being tested in trial NCT03115359?
The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL), Mindfulness Based Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03115359?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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