Building a Swiss Pain Registry: A National Framework for Acute and Chronic Pain Assessment
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
The study population consists of patients referred for interdisciplinary outpatient assessment and management of acute and chronic pain. The registry includes paediatric and adult patients of all genders across the full spectrum of acute and chronic pain conditions in routine clinical care.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Pain Registry Cohort
Trial outcomes
Primary outcomes
1
Feasibility of baseline assessment
Feasibility is defined as the proportion of eligible participants who complete the full multidomain digital baseline assessment across all predefined domains.
Time frame
Baseline (at enrollment)2
Data quality of baseline assessment
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).
Time frame
Baseline (at enrollment)Secondary outcomes
1
Pain intensity
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.
Time frame
Baseline, 6, 12, 18, 24 months2
Pain interference
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.
Time frame
Baseline, 6, 12, 18, 24 months3
Neuropathic pain screening
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.
Time frame
Baseline, 6, 12, 18, 24 months4
Neuropathic pain symptom profile
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.
Time frame
Baseline, 6, 12, 18, 24 monthsOther outcomes
1
Post-intervention pain intensity and interference
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).
Time frame
Approximately 1 week after intervention (post-intervention follow-up; variable depending on clinical trigger)2
Post-intervention side effects and adverse events
Patient-reported side effects and adverse events collected approximately one week after intervention using structured questionnaire items.
Time frame
Approximately 1 week after intervention (post-intervention follow-up; variable depending on clinical trigger)3
Post-intervention treatment satisfaction and perceived effectiveness
Patient-reported satisfaction, perceived effectiveness, and acceptability of the intervention assessed approximately one week after treatment using structured questionnaire items.
Time frame
Approximately 1 week after intervention (post-intervention follow-up; variable depending on clinical trigger)Sponsors and contacts
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Source ClinicalTrials.gov
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