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临床试验/NCT07453524
NCT07453524尚未招募不适用

Assessing Chronic Pain Patient Preferences Regarding the Analgesic Effect Relative to the Side Effects of Analgesic Drugs

Université Catholique de Louvain0 个研究点目标入组 200 人开始时间: 2026年3月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Chronic pain patient preferences of pain medications regarding pain relief relative to the side effects using numeric rating scales (adaptation of the outcome prioritization tool).

研究概览

简要总结

The goal of this study is to ask chronic pain patients their preferences regarding which side effects of pain medications are least acceptable in relation to their pain relief benefits. This information may help in the selection of improved treatment options in the future.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

入选标准

  • Aged over 18 years.
  • Being treated with pain medication.
  • (Chronic-)Pain for at least 3 months.
  • Capacity to understand and provide an informed consent form.

排除标准

  • Insufficient French or English language skills.
  • Epilepsy treated by an anti-epileptic.
  • Alzheimer's disease.
  • Parkinson's disease

研究组 & 干预措施

Chronic pain patients

Other

干预措施: Patient questionnaire (Other)

结局指标

主要结局

Chronic pain patient preferences of pain medications regarding pain relief relative to the side effects using numeric rating scales (adaptation of the outcome prioritization tool).

时间窗: Single measure at a time selected by the participant within the study period (up to 15 months).

Using numeric rating scales from 0 to 10 (adaptation of the outcome prioritization tool) to assess patient perceived importance of analgesic effect relative to not having the following side effects: fatigue, drowsiness (sleepiness), dizziness, difficulty concentrating, nausea, constipation (difficulty passing stools), dry mouth, unintentional weight gain, addiction (medication craving). Higher scores mean the specific outcome is a higher priority for the participant.

次要结局

  • Analgesic side effect burden measured by numeric rating scales (NRS)(Single measure at a time selected by the participant within the study period (up to 15 months).)
  • Patient pain levels in the last 24 hours and pain body location and its impact on functioning measured by the Brief Pain Inventory short form (BPI-SF).(Single measure at a time selected by the participant within the study period (up to 15 months).)
  • Overall pain levels in the past 7 days measured by a numeric rating scale.(Single measure at a time selected by the participant within the study period (up to 15 months).)
  • Overall sleep quality in the past 7 days measured by a numeric rating scale.(Single measure at a time selected by the participant within the study period (up to 15 months).)
  • Satisfaction of pain treatment will be assessed by select items from the PTSS(Single measure at a time selected by the participant within the study period (up to 15 months).)
  • Evaluating Patient characteristics(Single measure at a time selected by the participant within the study period (up to 15 months).)
  • MacArthur Scale of Subjective Social Status assessing subjective social status(Single measure at a time selected by the participant within the study period (up to 15 months).)
  • Single Item Global Quality of Life Scale (SIG-QoL)(Single measure at a time selected by the participant within the study period (up to 15 months).)
  • Patient Health Questionnaire-4 (PHQ-4) is used to measure anxiety and depression(Single measure at a time selected by the participant within the study period (up to 15 months).)
  • Current Opioid Misuse Measure - 9 items (COMM-9) is used to identify current aberrant opioid-related behavior in chronic pain patients on long-term opioid therapy(Single measure at a time selected by the participant within the study period (up to 15 months).)
  • PROMIS Item Bank v2.0 - Cognitive Function- Short Form 4a assesses patient-perceived cognitive deficits.(Single measure at a time selected by the participant within the study period (up to 15 months).)

研究者

申办方类型
Other
责任方
Sponsor

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