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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: Completed NA study, sponsored by University of Wisconsin, Madison.
NCT03115359 is a NA study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 770 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Averaged 4 pain severity items from the Brief Pain Inventory (0-10 scale; higher indicates higher level of pain)
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 |
What the finished NCT03115359 record still lists
NCT03115359 is an interventional study that assigns participants to a tested intervention. The registered 770 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 (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive Behavioral Therapy is the first listed.
NCT03115359 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03115359's enrollment target sits among peer trials
770 143rd of 2000 higher than 1,856 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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