Chronic PainNCT07717762
Building a Swiss Pain Registry: A National Framework for Acute and Chronic Pain Assessment
An observational study of Chronic Pain and Acute Pain, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pain, Acute Pain
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jul 2026to 15 Aug 2029
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Universitätsklinik für Anästhesiologie und Schmerzmedizin, Inselspital, Universitätsspital Bern
Bern, Canton of Bern, 3010
+41 31 632 21 11, schmerz@insel.ch
Michael A Harnik, MD
About this study
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.
Read the 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.
- Conditions
- Chronic Pain, Acute Pain
- Medical subject headings
- Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pain Registry Cohort | Participants enrolled in the Swiss Pain Registry. The cohort includes patients with acute and chronic pain receiving routine clinical care. No intervention is assigned; data are collected observationally through clinical documentation and patient-reported outcome measures over a follow-up period of up to 24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at enrollment)
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).
Measured: Baseline (at enrollment)
Secondary outcomes (12)
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.
Measured: Baseline, 6, 12, 18, 24 months
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.
Measured: Baseline, 6, 12, 18, 24 months
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.
Measured: Baseline, 6, 12, 18, 24 months
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.
Measured: Baseline, 6, 12, 18, 24 months
Functional disability
Functional disability assessed using the Oswestry Disability Index (ODI). Total scores range from 0 to 100, with higher scores indicating greater disability.
Measured: Baseline, 6, 12, 18, 24 months
Work ability
Work ability assessed using the Work Ability Index (WAI). Total scores range from 7 to 49, with higher scores indicating better work ability.
Measured: Baseline, 6, 12, 18, 24 months
Psychological distress
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.
Measured: Baseline, 6, 12, 18, 24 months
Pain catastrophizing
Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS). Total scores range from 0 to 52, with higher scores indicating greater catastrophizing.
Measured: Baseline, 6, 12, 18, 24 months
Sleep quality
Sleep quality assessed using the Bernese Sleep Health Questionnaire (BSHQ). Higher scores indicate worse sleep quality.
Measured: Baseline, 6, 12, 18, 24 months
Health-related quality of life
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.
Measured: Baseline, 6, 12, 18, 24 months
Global patient-reported improvement
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".
Measured: 6, 12, 18, 24 months
Follow-up completion and adherence
Completion rates of PROM assessments, adherence to follow-up schedules, and workflow integration indicators including proportion of home versus clinic completion and completion time.
Measured: 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Aug 2029 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Harnik, MD, Principal investigator, Universitätsklinik für Anästhesiologie und Schmerzmedizin, Inselspital, Universitätsspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717762
- Sponsor's protocol ID
- 2026-00636
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) collected within this registry are currently not planned for routine sharing with external researchers. Any future sharing of de-identified or coded datasets will be considered on a case-by-case basis and will require appropriate ethical approval, data transfer agreements, and compliance with applicable Swiss data protection regulations and institutional policies. No direct identifiers will be shared at any time.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building a Swiss Pain Registry: A National Framework for Acute and Chronic Pain Assessment
- ClinicalTrials.gov ID
- NCT07717762
- Acronym / sponsor ID
- 2026-00636
- Conditions
- Chronic Pain, Acute Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Aug 2029 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain Registry Cohort | – | –Participants enrolled in the Swiss Pain Registry. The cohort includes patients with acute and chronic pain receiving routine clinical care. No intervention is assigned; data are collected observationally through clinical documentation and patient-reported outcome measures over a follow-up period of up to 24 months. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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).
12 secondary outcomes
Pain intensity
Time frame: Baseline, 6, 12, 18, 24 months
Pain interference
Time frame: Baseline, 6, 12, 18, 24 months
Neuropathic pain screening
Time frame: Baseline, 6, 12, 18, 24 months
Neuropathic pain symptom profile
Time frame: Baseline, 6, 12, 18, 24 months
Functional disability
Time frame: Baseline, 6, 12, 18, 24 months
Work ability
Time frame: Baseline, 6, 12, 18, 24 months
Psychological distress
Time frame: Baseline, 6, 12, 18, 24 months
Pain catastrophizing
Time frame: Baseline, 6, 12, 18, 24 months
Sleep quality
Time frame: Baseline, 6, 12, 18, 24 months
Health-related quality of life
Time frame: Baseline, 6, 12, 18, 24 months
Global patient-reported improvement
Time frame: 6, 12, 18, 24 months
Follow-up completion and adherence
Time frame: 6, 12, 18, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) collected within this registry are currently not planned for routine sharing with external researchers. Any future sharing of de-identified or coded datasets will be considered on a case-by-case basis and will require appropriate ethical approval, data transfer agreements, and compliance with applicable Swiss data protection regulations and institutional policies. No direct identifiers will be shared at any time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael A Harnik, MD principal investigator
Universitätsklinik für Anästhesiologie und Schmerzmedizin, Inselspital, Universitätsspital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Acute Pain, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael A Harnik, MD (+41 31 632 30 27, michael.harnik@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of baseline assessment (time frame: Baseline (at enrollment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.