The Role of Endogenous Opioids in Mindfulness-based Chronic Pain Relief
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Pain Ratings
研究概览
简要总结
The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.
详细描述
The purpose of this psychophysical and pharmacologic study is to determine if meditation induced pain relief is mediated by endogenous opioids in response to intravenous (IV) administration of the opioid antagonist naloxone during a pain evoking straight leg raise test in response to double-blind intravenous administration (IV) of naloxone/placebo-saline. The aim of this study is to determine if mindfulness-based analgesia is associated with the release of endogenous opioids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the study physician, research coordinator, and research pharmacist will be aware of drug assignments. Research staff (nurses; research technicians) and the PI will be blinded to drug assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis
- •Participants must be between 18 and 65 years of age
- •Participants must rate their daily chronic pain intensity at a 3 or higher on 0-10 visual analog scale
- •Participants must have experienced their chronic low back pain for at least 3 months
- •Participants must have no prior meditative experience
- •Participants must be straight leg raise test positive
排除标准
- •Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period
- •Participants must not be taking opioids
- •Participants must not be pregnant or nursing mothers
- •Participants must have not had back surgery within the last year before their enrollment into the study
- •Participants must have not had any other sensory or motor deficits that preclude participation in this study
- •Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, and a personal history of psychosis
- •Participants must not have any known allergies to naloxone or similar drugs
- •Participants must not have a history of syncope and/or fear of needles/blood
研究组 & 干预措施
Meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
干预措施: Mindfulness (Behavioral)
Meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
干预措施: Naloxone (Drug)
Meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
干预措施: Saline (Other)
Meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
干预措施: Meditation (Behavioral)
meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
干预措施: Mindfulness (Behavioral)
meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
干预措施: Naloxone (Drug)
meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
干预措施: Saline (Other)
meditation
Subjects will participate in four sessions (20 min/session) of mindfulness training. Participants will be taught that perceived sensory events are "momentary" and "fleeting" and require no further evaluation.
干预措施: Meditation (Behavioral)
结局指标
主要结局
Pain Ratings
时间窗: Pain ratings were collected while lying supine and in response to the straight leg raise test. Collected twice, once in the first half and one in the second half of the baseline, saline infusion and naloxone infusion sessions. Up to 8 weeks total.
Numerical pain ratings (NRS) will be assessed while lying on the back and in response to the straight leg raise test (SLR). Pain ratings will be collected during SLR 1 and SLR 2 in the baseline, saline and naloxone sessions, respectively. The 11 point scan will include a minimum rating of "0" which is characterized as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable"." Higher numbers correspond to higher pain.
次要结局
- Pain Catastrophizing Scale(The Pain Catastrophizing Scale was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare change in Pain Catastrophizing Scale from baseline to session 7.)
- The Roland-Morris Disability Questionnaire (RMDQ)(The Roland-Morris Disability Questionnaire was administered at the baseline, post-intervention session 6 and session 7. Outcome measurements will compare RMDQ from baseline to session 7.)
- Brief Pain Inventory (BPI)(Administered at the baseline, post-intervention session 6 and post-intervention session 7. Outcome measurements will compare in BPI severity and interference from baseline to session 7.)
研究者
Fadel Zeidan
Assistant Professor
University of California, San Diego