Long-Term Opioid Therapy in Chronic Non-Cancer Pain: Risks and Benefits - A Prospective Cohort Study of Patients Treated in Specialized Pain Care
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Characterization and changes in opioid use disorder
研究概览
简要总结
The study investigates long-term opioid treatment in patients with chronic non-cancer pain (CNCP). The study aims to prospectively identify predictive factors for work ability and for developing opioid use disorder (according to DSM-5) as well as predictive factors for pain, activity, and health-related quality of life.
It is hypothesized that certain biopsychosocial factors mapped in this study predict patterns of opioid use and the risk for developing OUD for patients with CNCP on long-term opioid therapy. Further, it is hypothesized that certain biopsychosocial factors mapped in this study predict the chance of improved work ability and other treatment benefits of long term opioid therapy in patients with CNCP.
详细描述
Chronic pain affects nearly 20% of the Swedish population. Pain from the musculoskeletal system together with psychiatric disorders are the chronic conditions that cost the most for the Swedish health care disability insurance and health care systems. Current knowledge suggests that chronic pain is maintained by changes in the nervous system together with psychological and social factors.
Opioids are known to be effective for acute and post-operative pain, and can be indispensable in palliative treatment of cancer pain. Long-term opioid therapy on the other hand is associated witg several risks, e.g., development of opioid dependence and opioid use disorder (OUD), and other opioid related complications including premature death. Clinical experience, qualitative and quantitative research suggest that some individuals with chronic pain do benefit from long-term opioid therapy in terms of clinical significant pain relief with only a low level of negative side-effects. However, evidence of change in functional outcomes and health related quality of life is ambiguous. Therefore, the role of long-term opioid therapy in chronic pain conditions remains debated and sometimes controversial.
In contrast to the well-established opioid epidemic in the U.S., little is known about the use of prescribed opioids in Sweden, and how this has developed during the last decade. The annual prevalence of opioid prescription did not change much during 2006-2017, but there were significant shifts in choice of opioids, with an increase in strong opioids e.g., oxycodone and morphine. Very little is known about what clinical consequences this shift might lead to.
The U-PAIN cohort study aims to examine patterns of prescribed opioid use, risks of adverse effects of long-term opioid therapy, and benefits of long-term opioid therapy, in a prospective clinical cohort.
The study aims to complete a broad bio-psycho-social characterization of the participants relevant to chronic pain. The study participants are followed over 5 years in order to study trajectories for patterns of opioid use, and predictive factors for opioid use disorder, work ability, pain severity and interference, and health-related quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Referral for a first visit to the Pain Centre of Uppsala University Hospital. The following
- •Competent in Swedish
- •Chronic Non-Cancer Pain (pain > 90 days)
排除标准
- •In active cancer treatment/Cancer-related pain
- •In palliative care
- •Need for interpreter
- •Cognitive impairment of magnitude that will prevent completion of study or ability to give informed consent
结局指标
主要结局
Characterization and changes in opioid use disorder
时间窗: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
As defined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Measured by: Structured interview: Modified version of the Swedish Mini International Neuropsychiatric Interview, Part J (Substance use). Response format yes/no. Mild opioid use disorder = 2-3 symptoms Moderate opioid use disorder = 4-5 symptoms Severe opioid use disorder = 6 or more symptoms
Changes in work ability
时间窗: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years
Self report. Work Ability Index (WAI). The questionnaire covers 7 dimensions: 1. current work ability compared with lifetime best 2. work ability in relation to the demands of the job 3. number of diagnosed illnesses or limiting conditions 4. estimated impairment owing to diseases/illnesses or limiting conditions 5. amount of sick leave during the last year 6. prognosis of work ability in 2 years' time 7. psychological resources. The dimensions have different scores. A total index is computed ranging from 7 to 49, where higher scores indicate higher work ability. Individual items or sub-scales of WAI may also be used as outcome measures.
次要结局
- Changes and patterns of opioid use (type of opioid, dose, and duration)(Baseline, 1 year, 2 years, 3 years, 4 years, 5 years)
- Changes in health related quality of life: EQ-5D-5L(Baseline, 1 year, 2 years, 3 years, 4 years, 5 years)
- Changes in pain severity and pain interference: The Brief Pain Inventory short-form (BPI-SF)(Baseline, 1 year, 2 years, 3 years, 4 years, 5 years)
- Catastrophizing - The Pain Catastrophizing Scale (PCS) - Swedish version.(Baseline)
- Illicit drug use(Baseline)
- Explorative identification of change in biomarkers(Baseline)
- Generalised Anxiety Disorder(Baseline)
- Fear of movement and reinjury(Baseline)
- Depressive symptoms(Baseline)
- Pain self-efficacy(Baseline)
- Changes in life habits(Baseline, 1 year, 2 years, 3 years, 4 years, 5 years)
- Experienced effect of treatment/Global goal achievement(5 year)
- Sleep(Baseline)
- Experienced injustice(Baseline)
- Personality traits(Baseline)
- Life-time experience of traumatic events(Baseline)
- Walk speed(Baseline)
- Balance(Baseline)
- Alcohol Use(Baseline)
- Attention-deficit hyperactivity disorder (ADHD) symptoms(Baseline)
- Pain classification(Baseline)
- Substance use and substance use disorder(Baseline)