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临床试验/NCT03485430
NCT03485430已完成不适用

Tapering of Prescribed Opioids in Patients With Long-term Non-malignant Pain - Efficacy and Effects on Pain, Pain Cognitions, and Quality of Life (TOPIO): a Study Protocol for a Randomized Controlled Clinical Trial With a 12 Month Follow-up

Lund University Hospital3 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年3月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
3
主要终点
Opioid consumption

研究概览

简要总结

This randomized controlled study compares tapering of long-term opioid therapy in a population with chronic non-cancer pain with control group constituted of waiting list. Half of participants receives intervention at baseline and the other half are controls but receives intervention after 4 months. Ethical approval to follow up excluded participants denying tapering at baseline.

详细描述

Chronic non-cancer pain is a major problem in society and a common cause to seek health care. The suffering is complex as it, besides pain, often includes psychological symptoms and may decrease the ability to participate in work life. Pharmacological treatments have limited possibilities to ease suffering. Opioids used in this population have evidence to ease pain and to some extent increase physical ability when used in limited treatment periods and in selected patients. Medium to long-term opioid therapy, extended beyond three months, lack evidence of easing pain or increase physical ability.

The current study is conducted on three specialized pain care units (Skane University Hospital; Lund, Sahlgrenska University Hospital Gothenburg and University Hospital, Linkoeping) and aims at taper long-term opioid therapy with support from physician and nurse and study the effects of tapering.

Method: Randomized controlled study, without concealment. Waiting-list constitutes the control-group. Intervention means tapering with a motivated patient. Follow up at four and twelve months.

Primary end-point: collected opioid prescriptions registered in The National Board of Health and Welfare registry expressed in milligram of morphine equivalent.

Secondary end-point: Data will be retrieved from the Swedish Quality Registry for Pain Rehabilitation. The database contains participants' self-report of variables measuring the impact of rehabilitation on depressive symptoms, anxiety, rating of pain and acceptance to pain. Assessments are made prior to, at the end of and one year after discharge of the rehabilitation program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • A long-term opioid therapy with daily intake due to chronic pain condition, by prescription. Willing to enter an intervention aiming at taper opioid therapy.

排除标准

  • No daily intake of opioids. Shorter duration of opioid therapy than 3 months. Repeated intake of non-prescribed opioids or other illegal drugs. Refusal to perform drug-screening Perceived medical risks of waiting with tapering of opioids (e.g: raising opioid doses after acute pancreatitis caused by excessive alcohol intake or kidney disease stage 4-5 in combination with excessive alcohol intake and high doses of opioids).

研究组 & 干预措施

Intervention

Active Comparator

Receives tapering of opioid dose at baseline

干预措施: Tapering (Behavioral)

Control

No Intervention

Waiting-list. Receives tapering after 4 months.

结局指标

主要结局

Opioid consumption

时间窗: 4 months

Self reported consumption

Opioid consumption

时间窗: 12 months

Data retrieved from National Boars of Health and Welfare, collected prescribed opioid drugs

次要结局

  • Numeric Pain Rating Scale (NPRS)(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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