Neural Mechanisms of Meditation-Based Interventions for Chronic Low Back Pain
概览
- 阶段
- 不适用
- 干预措施
- Meditation
- 疾病 / 适应症
- Low Back Pain
- 发起方
- University of Utah
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Blood oxygenation level dependent (BOLD) signaling
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
The purpose of this research study is to see how a mindfulness meditation-based intervention affects pain. Specifically, we are interested in understanding the pain-relieving brain mechanisms of mindfulness meditation-based therapy for patients with opioid-treated chronic low back pain.
研究者
Eric Garland
Associate Dean for Research
University of Utah
入排标准
入选标准
- •1\) men/women 18-65 years of age; 2) current chronic low back pain classified according to the NIH Pain Consortium task force research standards for chronic low back pain (pain on at least half the days in the past 6 months); usual back pain ≥3 on 0-10 scale with opioid medication; and 4) current use of prescription opioids for ≥3 months.
排除标准
- •1\) Prior experience with MBSR, MBCT, MORE, or extensive involvement in any standardized meditation training, 2) current cancer diagnosis, 3) suicide intent or attempt in the past 30 days, 4) psychosis or moderate/severe non-opioid substance use disorder in past 6 months; 5) persons with any electronic objects or certain metal objects in their head or body that are incompatible with MRI; 6) those who have had an abnormal brain MRI in the past; 7) those unable to lie still on their back for 1 to 1.5 hours; and 8) pregnancy.
研究组 & 干预措施
Mindfulness
A well-validated mindfulness meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.
干预措施: Meditation
Mindfulness
A well-validated mindfulness meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.
干预措施: Usual care
Meditation
A validated meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.
干预措施: Meditation
Meditation
A validated meditation-based therapy \[8 sessions\] is used to teach patients to independently practice meditation to cope with pain.
干预措施: Usual care
Usual Care
Patients will receive usual medical care for chronic low back pain.
干预措施: Usual care
结局指标
主要结局
Blood oxygenation level dependent (BOLD) signaling
时间窗: At baseline and at post-treatment (8 weeks)
Changes in blood oxygenation levels to thermally noxious stimuli (48°C) will be assessed.
次要结局
- Pain catastrophizing(At baseline, post-treatment (8 weeks), and 3-month follow-up)
- Self-transcendence(At baseline, post-treatment (8 weeks), and 3-month follow-up)
- Visual Analog Scale Pain Ratings(At baseline and at post-treatment (8 weeks))
- Chronic pain symptoms(At baseline, post-treatment (8 weeks), and 3-month follow-up)
- Opioid dose(At baseline, post-treatment (8 weeks), and 3-month follow-up)
- Mindful reinterpretation of pain sensations(At baseline, post-treatment (8 weeks), and 3-month follow-up)
- Trait mindfulness(At baseline, post-treatment (8 weeks), and 3-month follow-up)