Acute Pain, Chronic Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of baseline assessment | Baseline (at enrollment) | Feasibility is defined as the proportion of eligible participants who complete the full multidomain digital baseline assessment across all predefined domains. |
| Data quality of baseline assessment | Baseline (at enrollment) | Data quality will be evaluated by completeness of core variables of the multidomain digital baseline assessment (percentage of missing data at item and domain level). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Baseline, 6, 12, 18, 24 months | Pain intensity measured using the Brief Pain Inventory (BPI). The BPI uses numeric rating scales from 0 to 10, where higher scores indicate greater pain intensity. |
| Pain interference | Baseline, 6, 12, 18, 24 months | Pain interference measured using the Brief Pain Inventory (BPI). The BPI uses numeric rating scales from 0 to 10, where higher scores indicate greater pain interference. |
| Neuropathic pain screening | Baseline, 6, 12, 18, 24 months | Neuropathic pain symptoms assessed using the Douleur Neuropathique 4 (DN4) questionnaire. Total scores range from 0 to 10, with higher scores indicating greater likelihood of neuropathic pain. |
| Neuropathic pain symptom profile | Baseline, 6, 12, 18, 24 months | Neuropathic pain symptom profile assessed using the Neuropathic Pain Symptom Inventory (NPSI). Total scores range from 0 to 100, with higher scores indicating more severe neuropathic pain symptoms. |
| Functional disability | Baseline, 6, 12, 18, 24 months | Functional disability assessed using the Oswestry Disability Index (ODI). Total scores range from 0 to 100, with higher scores indicating greater disability. |
| Work ability | Baseline, 6, 12, 18, 24 months | Work ability assessed using the Work Ability Index (WAI). Total scores range from 7 to 49, with higher scores indicating better work ability. |
| Psychological distress | Baseline, 6, 12, 18, 24 months | Psychological distress (anxiety, depression) assessed using the Patient Health Questionnaire-4 (PHQ-4). Total scores range from 0 to 12, with higher scores indicating greater anxiety and depressive symptoms. |
| Pain catastrophizing | Baseline, 6, 12, 18, 24 months | Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS). Total scores range from 0 to 52, with higher scores indicating greater catastrophizing. |
| Sleep quality | Baseline, 6, 12, 18, 24 months | Sleep quality assessed using the Bernese Sleep Health Questionnaire (BSHQ). Higher scores indicate worse sleep quality. |
| Health-related quality of life | Baseline, 6, 12, 18, 24 months | Health-related quality of life assessed using the World Health Organization Quality of Life - BREF (WHOQOL-BREF). Total scores range from 0 to 100, with higher scores indicating better quality of life. |
| Global patient-reported improvement | 6, 12, 18, 24 months | Global improvement measured using the Patient Global Impression of Change (PGI-C). The PGI-C is a 7-point scale ranging from "very much worse" to "very much improved". |
| Follow-up completion and adherence | 6, 12, 18, 24 months | Completion rates of PROM assessments, adherence to follow-up schedules, and workflow integration indicators including proportion of home versus clinic completion and completion time. |
Countries
Switzerland
Contacts
CONTACTMichael A Harnik, MD
PRINCIPAL_INVESTIGATORMichael A Harnik, MD
Universitätsklinik für Anästhesiologie und Schmerzmedizin, Inselspital, Universitätsspital Bern
Outcome results
None listed