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临床试验/NCT07287072
NCT07287072
尚未招募
不适用

Pain Reprocessing Therapy for Chronic Primary Pain Caused by a Likely Nociplastic Pain Mechanism in Primary Care: The PRIME-PRT Trial

University of Oslo1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年2月1日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
12
试验地点
1
主要终点
Average pain rating in the past 7 days on a numerical rating scale from 0-10 from Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29)

概览

简要总结

Approximately 30% of adult Norwegians experience chronic pain, with its prevalence rising across demographics, including children and adolescents Chronic pain contributes to significant personal suffering and substantial societal costs. Traditional treatments - physical, pharmacological, and surgical - as well as psychological interventions, such as cognitive and acceptance-based therapies, demonstrate only minor to modest effects.

To address the challenge of rising demand alongside limited treatment options, university hospitals must consistently evaluate and adopt new, potentially effective therapies to meet their societal mission. Pain Reprocessing Therapy (PRT) is one such innovative treatment that has recently demonstrated promising results for a subset of chronic pain patients in a U.S. primary care setting.

In this study, the investigators want to assess the effectiveness of PRT on various outcomes in patients with primary chronic pain that has a likely nociplastic pain mechanism, within a Norwegian primary care population.

The insights from this study will be important for any prospective implementation of PRT to align with one of the guiding principles of the Norwegian healthcare system: the Best Effective Level of Care (BEON principle). The BEON principle supports the delivery of high-quality, cost-effective healthcare services and is founded on the notion of seamless integration across different levels of care. When competence or resources at the primary healthcare level are insufficient, more patients tend to be referred to higher, specialized, and inherently more costly levels of care, such as secondary and tertiary care. Therefore, if the study can demonstrate that PRT is effective within a Norwegian primary care population, the hypothesize is that its implementation could strengthen both primary and tertiary care in alignment with the BEON principle.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 70
  • On sick leave, or at risk of sick leave
  • Pain intensity corresponding to 3 (or more) on the NRS from the PROMIS-
  • Readiness to change, corresponding to the action stage from the readiness to change model, where they are ready to participate in their own change process

排除标准

  • Structural causes for their pain (rheumatoid arthritis, cancer, etc.),
  • Severe psychiatric conditions (ongoing or previous psychotic disorders, suicidality, or severe depression/anxiety/bipolar disorder)
  • Illegal substance abuse, or known dependence on benzodiazepines or opioids
  • Ongoing litigation or compensation process related to the pain condition
  • Ongoing and severe psychosocial stressors (e.g. recent divorce etc.)

结局指标

主要结局

Average pain rating in the past 7 days on a numerical rating scale from 0-10 from Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29)

时间窗: 5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session)

Pain intensity average last week assessed through one item. The scale ranges from 0 (no pain) to 10 (worst imaginable pain)

次要结局

  • Physical function measured through PROMIS-29(5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session) and at 1 year follow-up)
  • Patient Global Impression of Change(5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session))
  • Individual goals assessed through Goal Attainment Scaling (GAS)(5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session) and at 1 year follow-up)
  • Work participation at 1-year follow-up(Assessed through self-report at 5 weeks follow-up and 1 year follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silje Endresen Reme

Professor and psychologist

Oslo University Hospital

研究点 (1)

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