Building a Swiss Pain Registry: A National Framework for Acute and Chronic Pain Assessment

Обзор

The goal of this observational registry is to systematically collect and analyse real-world clinical and patient-reported data in individuals receiving treatment for acute and chronic pain. The main questions it aims to answer are: How do pain intensity, functional status, and quality of life evolve over time in patients with acute and chronic pain? How are different routine clinical treatment approaches associated with patient-reported outcomes in real-world clinical practice? Participants already receiving standard care for pain management will have routine clinical data recorded as part of their treatment and will be asked to complete standardized questionnaires on pain intensity, functional status, and quality of life at multiple time points during treatment and follow-up. Data are collected using a secure electronic system and are pseudonymised prior to analysis in accordance with Swiss data protection regulations.

Подробное описание

This prospective, observational registry study aims to establish a standardized, multidomain digital assessment platform for patients with acute and chronic pain within routine outpatient care at the University Hospital Bern. The registry is designed as a scalable national infrastructure with planned expansion to additional Swiss pain clinics. The primary objective is to evaluate feasibility, acceptability, and data quality of a digital baseline assessment integrating validated patient-reported outcome measures (PROMs) across pain, functional, psychological, sleep, and quality-of-life domains. Secondary objectives include the description of baseline patient profiles, exploration of longitudinal outcomes at 6, 12, 18, and 24 months, assessment of operational feasibility of follow-up assessments, and investigation of sex- and gender-related differences. In addition, optional treatment-triggered follow-up modules may be used after therapeutic interventions to capture short-term outcomes, side effects, and patient-reported treatment satisfaction. Data are collected prospectively via REDCap and include both routinely documented clinical data and additional patient-reported outcomes. The study duration is 36 months, including a 12-month recruitment phase and 24 months of follow-up per participant.

Первичные конечные точки

• Feasibility of baseline assessment [Срок оценки: Baseline (at enrollment)]
• Data quality of baseline assessment [Срок оценки: Baseline (at enrollment)]

Вторичные конечные точки (12)

• Pain intensity [Срок оценки: Baseline, 6, 12, 18, 24 months]
• Pain interference [Срок оценки: Baseline, 6, 12, 18, 24 months]
• Neuropathic pain screening [Срок оценки: Baseline, 6, 12, 18, 24 months]
• Neuropathic pain symptom profile [Срок оценки: Baseline, 6, 12, 18, 24 months]
• Functional disability [Срок оценки: Baseline, 6, 12, 18, 24 months]
• Work ability [Срок оценки: Baseline, 6, 12, 18, 24 months]
• Psychological distress [Срок оценки: Baseline, 6, 12, 18, 24 months]
• Pain catastrophizing [Срок оценки: Baseline, 6, 12, 18, 24 months]
• Sleep quality [Срок оценки: Baseline, 6, 12, 18, 24 months]
• Health-related quality of life [Срок оценки: Baseline, 6, 12, 18, 24 months]
• Global patient-reported improvement [Срок оценки: 6, 12, 18, 24 months]
• Follow-up completion and adherence [Срок оценки: 6, 12, 18, 24 months]

Критерии участия

Критерии включения

• Signed informed consent by the participant or legal guardian for minors.
• Diagnosis of acute or chronic pain (chronic pain defined as pain lasting ≥ 3 months), including nociceptive, neuropathic, or mixed pain conditions.
• Referral for interdisciplinary outpatient pain assessment or treatment.
• Sufficient proficiency in German, French, Italian, or English to complete digital assessments (parental proxy allowed for paediatric participants if needed).
• All age groups included.

Критерии исключения

• Lack of capacity to provide informed consent or absence of a legal guardian for minors.
• Inability to understand study languages and complete assessments even with assistance.
• Acute life-threatening conditions precluding participation.
• Site-specific safety considerations as determined by treating clinician.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Швейцария · 1 центр

• Universitätsklinik für Anästhesiologie und Schmerzmedizin, Inselspital, Universitätsspital — Bern

Идентификаторы

NCT: NCT07717762 · 2026-00636

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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