Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms
2017年6月14日 更新者：Ajay D. Wasan,M.D.,M.Sc.、Brigham and Women's Hospital
Opioids are frequently prescribed for chronic low back pain (CLBP).
Psychiatric illness, such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain patients (and is termed comorbid negative affect [NA]).
The purpose of the study is to determine whether CLBP patients with either a high vs. a low or moderate degree of NA have different pain relief responses to oral opioids.
研究概览
详细说明
The level of high, moderate or low NA was determined based on the participant's score on the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-reported questionnaire that has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each item on the questionnaire is scored from 0 (least amount of anxiety/depression) to 3 (greatest amount of anxiety/depression), with total score between 0 and 21 for either anxiety or depression. Participants were assigned to high, moderate or low NA groups using the following HADS score criteria:
- High NA = HADS score ≥9 on each subscale
- Moderate NA = HADS score ≥6 to ≤8 on each subscale
- Low NA = HADS score ≤5 on each subscale
研究类型
介入性
注册 (实际的)
81
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Massachusetts
-
Chestnut Hill、Massachusetts、美国、02467
- Brigham and Women's Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Low Back Pain > 3/10
- Pain > 1 year
- Degenerative disc disease as seen on magnetic resonance imaging (MRI), which must meet minimum disc grading criteria: at least a grade III disc degeneration, a hyperintense zone, or abnormal disc morphology.
- Patients who may have had back surgery will be included.
- No epidural steroids or other nerve blocks for back pain either two weeks before or during the study period.
- No opioids or on short-acting opioids only (max. daily amount=120 mg morphine equivalents). It is not feasible to recruit only opioid naive patients.
- Must agree to 2-week washout for those on opioids.
- No active substance abuse.
- No intention to take new pain or psychiatric treatments during the study, including chiropractic, physical therapy, or complementary or alternative treatments (CAM). It is not feasible to take participants off of any other pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDS).
- No pregnancy or the intent to become pregnant during the study, and no nursing mothers.
- Women, who are able to bear children, must agree to use contraceptives throughout the study.
- In men, normal baseline testosterone levels.
Exclusion Criteria:
- Patients with pain due to disorders not including a component of disc degeneration, or those with unknown causes of pain will be excluded.
- Patients with the intent to undergo back surgery will be excluded.
- Patients with a history of recent or ongoing alcohol or other drug addiction disorders will be excluded.
- Patients with any history of substance abuse of opioids will be excluded.
- Patients whose diagnosis cannot be firmly established according to criteria described above would not be included.
- Patients whose medical and psychiatric comorbidities are not well controlled, or who are currently experiencing an acute exacerbation of the medical comorbidity, will be excluded.
- Males with abnormal testosterone levels will be excluded (normal range is 1800-6650 pg/ml).
- Female patients who nursing will be excluded.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Low Negative Affect (NA)
Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
|
Daily dosage up to 120 mg
Daily dosage up to 90 mg immediate release or 180 mg extended release
其他名称：
Placebo-matching oxycodone, placebo-matching morphine
|
|
有源比较器：Moderate NA
Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
|
Daily dosage up to 120 mg
Daily dosage up to 90 mg immediate release or 180 mg extended release
其他名称：
Placebo-matching oxycodone, placebo-matching morphine
|
|
有源比较器：High NA
Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
|
Daily dosage up to 120 mg
Daily dosage up to 90 mg immediate release or 180 mg extended release
其他名称：
Placebo-matching oxycodone, placebo-matching morphine
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent Change in Average Daily Pain Score
大体时间：Baseline and Week 20
|
Participants rated their average lower back pain over the past 24 hours using an 11-point scale (0=no pain to 10=worst possible pain) and recorded it in an electronic diary.
The percent change in pain score from baseline is calculated using weekly averages for up to 20 weeks.
Linear mixed modeling (LMM) analysis was used to allow for inclusion in the analysis of the majority of participants with any missing data.
For the LMM model, group, group × week, average baseline pain, and opioid use at baseline (yes/no) were entered as fixed effects using an autoregressive covariance structure.
Participant, intercept, and week were entered as random effects, using a compound symmetry covariance structure.
A positive change from baseline indicates an improvement.
|
Baseline and Week 20
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ajay D Wasan, MD, MSc、Brigham and Women's Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2009年2月1日
初级完成 (实际的)
2013年1月1日
研究完成 (实际的)
2013年1月1日
研究注册日期
首次提交
2011年12月28日
首先提交符合 QC 标准的
2011年12月29日
首次发布 (估计)
2012年1月2日
研究记录更新
最后更新发布 (实际的)
2017年7月11日
上次提交的符合 QC 标准的更新
2017年6月14日
最后验证
2017年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.