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Strategies to Assist With Management of Pain
NA trial testing Mindfulness Based Therapy in Chronic Low Back Pain in 770 participants. Completed in 15 January 2023.
| Lead sponsor | University of Wisconsin, Madison |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 770 |
| Start date | 30 June 2017 |
| Primary completion | 15 January 2023 |
| Estimated completion | 15 January 2023 |
| Sites | 4 locations across United States |
University of Wisconsin, Madison
21 and older, any sex, with Chronic Low Back Pain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Averaged 4 pain severity items from the Brief Pain Inventory (0-10 scale; higher indicates higher level of pain)
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 5.6 | ± 1.7 |
| Cognitive Behavioral Therapy | 5.6 | ± 1.8 |
Averaged 4 pain severity items from the Brief Pain Inventory (0-10 scale; higher indicates higher level of pain)
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 5.5 | ± 1.8 |
| Cognitive Behavioral Therapy | 5.5 | ± 1.9 |
10-item Oswestry Disability Index (0-100 scale; higher score indicates higher level of back pain-related functional limitation)
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 44.6 | ± 16.1 |
| Cognitive Behavioral Therapy | 45.1 | ± 16.4 |
10-item Oswestry Disability Index (0-100 scale; higher score indicates higher level of back pain-related functional limitation)
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 43.4 | ± 15.3 |
| Cognitive Behavioral Therapy | 43.2 | ± 15.4 |
1 'average' pain severity item from the Brief Pain Inventory (0-10 scale; higher score indicates higher level of pain)
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 5.6 | ± 1.7 |
| Cognitive Behavioral Therapy | 5.5 | ± 1.9 |
1 'average' pain severity item from the Brief Pain Inventory (0-10 scale; higher score indicates higher level of pain)
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 5.4 | ± 1.9 |
| Cognitive Behavioral Therapy | 5.5 | ± 2.0 |
12-item Short Form-12 (0-100 scale; higher score indicates better physical health function)
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 30.7 | ± 8.7 |
| Cognitive Behavioral Therapy | 29.9 | ± 9.4 |
12-item Short Form-12 (0-100 scale; higher indicates better physical health function)
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 30.5 | ± 8.8 |
| Cognitive Behavioral Therapy | 30.0 | ± 9.2 |
12-item Short Form-12 (0-100 scale; higher score indicates better mental health function)
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 43.2 | ± 11.4 |
| Cognitive Behavioral Therapy | 43.5 | ± 12.1 |
12-item Short Form-12 (0-100 scale; higher score indicates better mental health function)
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 43.5 | ± 11.5 |
| Cognitive Behavioral Therapy | 45.9 | ± 11.0 |
Timeline Followback Method (morphine-MG equivalent dose \[mg/day\] over the prior 14 days). Log transformation was required because of the skewed distribution of the daily opioid dose data in the primary effectiveness analysis.
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 119 | ± 521 |
| Cognitive Behavioral Therapy | 191 | ± 1603 |
Timeline Followback Method (morphine-MG equivalent dose \[mg/day\] over the prior 14 days). Log transformation was required because of the skewed distribution of the daily opioid dose data in the primary effectiveness analysis.
| Group | Value | 95% CI |
|---|---|---|
| Mindfulness Based Therapy | 144 | ± 556 |
| Cognitive Behavioral Therapy | 192 | ± 1644 |
Time frame: Adverse events were collected from enrollment through exit (12-month follow-up period) for each participant. Data on adverse events were systematically collected with a "negative side effects" survey at each assessment, and at each intervention session. In addition, study personnel inquired about potential adverse events at each participant contact. All adverse events were recorded, reported, and categorized according to the funding agency, IRB, and other regulatory guidance.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Mindfulness Based Therapy | Cognitive Behavioral Therapy |
|---|---|---|---|
| Increased pain reported as associated with progressive muscle relaxation exercise | Musculoskeletal and connective tissue disorders | — | — |
Data from ClinicalTrials.gov NCT03115359 adverse events section.
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 (383 participants) that will receive the MM training or CBT (383 participants) that will receive the CBT training. Due to the COVID-19 pandemic-related restrictions, the study protocol was modified in October 2020 so that the study can be completed virtually. The effectiveness of MM versus CBT will be assessed over a 12-month period with patient-reported measures, recommended by experts and endorsed by our stakeholder partners, including patients with opioid-treated CLBP, their families and clinicians.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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