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NCT Number: NCT07717762

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

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.

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Key information

Conditions

Chronic Pain Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik für Anästhesiologie und Schmerzmedizin, Inselspital, Universitätsspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location contact

Melissa L Flury, PhD

SUB_INVESTIGATOR

Michael A Harnik, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

+41 31 632 21 11

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Feasibility of baseline assessment

    Time frame: Baseline (at enrollment)

    Feasibility is defined as the proportion of eligible participants who complete the full multidomain digital baseline assessment across all predefined domains.

  2. Data quality of baseline assessment

    Time frame: 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 outcomes

  1. Pain intensity

    Time frame: 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.

  2. Pain interference

    Time frame: 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.

  3. Neuropathic pain screening

    Time frame: 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.

  4. Neuropathic pain symptom profile

    Time frame: 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.

  5. Functional disability

    Time frame: 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.

  6. Work ability

    Time frame: 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.

  7. Psychological distress

    Time frame: 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.

  8. Pain catastrophizing

    Time frame: 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.

  9. Sleep quality

    Time frame: Baseline, 6, 12, 18, 24 months

    Sleep quality assessed using the Bernese Sleep Health Questionnaire (BSHQ). Higher scores indicate worse sleep quality.

  10. Health-related quality of life

    Time frame: 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.

  11. Global patient-reported improvement

    Time frame: 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".

  12. Follow-up completion and adherence

    Time frame: 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.

Other outcomes

  1. Post-intervention pain intensity and interference

    Time frame: Approximately 1 week after intervention (post-intervention follow-up; variable depending on clinical trigger)

    Pain intensity and interference assessed approximately one week after therapeutic interventions using the Brief Pain Inventory (BPI; 0-10 scale, higher scores indicate worse pain and interference).

  2. Post-intervention side effects and adverse events

    Time frame: Approximately 1 week after intervention (post-intervention follow-up; variable depending on clinical trigger)

    Patient-reported side effects and adverse events collected approximately one week after intervention using structured questionnaire items.

  3. Post-intervention treatment satisfaction and perceived effectiveness

    Time frame: Approximately 1 week after intervention (post-intervention follow-up; variable depending on clinical trigger)

    Patient-reported satisfaction, perceived effectiveness, and acceptability of the intervention assessed approximately one week after treatment using structured questionnaire items.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael A Harnik, MD

CONTACT

[email protected]

+41 31 632 30 27

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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