Cognitive Function and Addiction in Patients With Chronic Pain Under Opioid Tapering in a Multidisciplinary Pain Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Cognitive function - sustained attention
研究概览
简要总结
This study evaluates the effects of opioid dose reduction in the treatment of chronic pain in adults. Participants were divided in two groups: 1) patients that reduced opioid dose and 2) patients that kept the same opioid dose for six months.
详细描述
BACKGROUND The indications for initiating long-term opioid treatment for chronic non-cancer pain are often unclear and may be associated with poor outcomes and problematic use. Few available studies demonstrated that opioids do not provide advantages regarding pain control, quality of life and functional capacity in this population and may have numerous serious adverse effects and consequences.
AIMS
This study aimed at:
- evaluating the feasibility of a opioid tapering off program to patients with chronic pain,
- investigating the influence of opioid tapering off on cognitive function, pain, symptoms of opioid withdrawal, anxiety , depression, and health related quality of life,
- investigating the prevalence of addiction in chronic pain patients in a long-term treatment,
- determining the predictive value of the Pain Medication Questionnaire (PMQ) in patients with chronic pain,
- investigating how opioid tapering off influences PMQ.
METHODS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 years old or more
- •at least seven years of schooling
- •pain duration of at least six months,
- •treatment with oral opioids for more than three months
- •daily opioid dose ≥ 60 mg of oral morphine equivalent
排除标准
- •not fluent in Danish language
- •cancer disease
- •poor general health condition
- •pregnancy, dementia
- •encephalopathy
- •brain damage
- •cranial base trauma
- •enrolled in other studies
研究组 & 干预措施
Taper off
Decrease of opioid daily dose until discontinuation for up to six months.
干预措施: Opioids taper off (Drug)
Control Group
No changes on opioids and adjuvant medication for up to six months.
干预措施: Opioid stable treatment (Drug)
结局指标
主要结局
Cognitive function - sustained attention
时间窗: Through study completion up to 4 years.
EKHO, computer program that registers the continuous reaction time to respond to the emission of a sound signal. Scores were summarized in milliseconds using 10th (fastest values), 50th and 90th (slowest values) percentiles. More prolonged times mean worse performance.
Cognitive function - psychomotor speed
时间窗: Through study completion up to 4 years.
Finger Tapping Test, a mechanical device with a key attached was used to record the number of taps. Score was calculated by the numbers of taps, considering the average of each hand and the differences between hands. Higher scores mean better performance.
Cognitive function - working memory
时间窗: Through study completion up to 4 years.
Digit Span Test, subjects should repeat orally series of numbers of increasing lengths, in forward and backward orders. Scores were calculated separately for forward and backward exercises, considering the number of correct repetitions. Scores range from 0 to 14. Higher scores mean better performance.
Cognitive function - mental flexibility
时间窗: Through study completion up to 4 years
Trail Making Test B, numbers and letters written on a paper should be connected in alternated sequence and increasing order. Score was calculated by the total time spent to correctly conclude the test (seconds). Shorter time mean better performance.
Cognitive function - mental state
时间窗: Through study completion up to 4 years.
Mini Mental State Examination, measures orientation to time and place, registration of words, attention, calculation, and word recall, as well as language and visual construction. Total scores range from 0 to 30; scores below 27 were considered indicative of cognitive dysfunction.
Risk of opioid misuse
时间窗: Through study completion up to 4 years.
Pain Medication Questionnaire, 26 items responded on a 5-point Likert format scale. Scores range from 0 to 104, higher score means higher risk of opioid misuse. Scores equal or above 22 were considered indicative of risk for opioid addiction.
次要结局
- Rest(Through study completion up to 4 years.)
- Quality of life(Through study completion up to 4 years.)
- Depression and anxiety(Through study completion up to 4 years.)
- Sleep(Through study completion up to 4 years.)
- Pain intensity(Through study completion up to 4 years.)
- Objective symptoms of opioid withdrawal(Through study completion up to 4 years.)
- Addiction - Portnoy's Criteria(Through study completion up to 4 years.)
- Subjective symptoms of opioid withdrawal(Through study completion up to 4 years.)
- Addiction - International Classification of Diseases -10.(Through study completion up to 4 years.)
研究者
Per Sjogren
Professor in palliative Medicine
Rigshospitalet, Denmark