Pain, PostoperativePROMPTNCT03834922
Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment
An observational study of Pain, Postoperative, run by Prof. Dr. Winfried Meissner at 1 site in Germany.
Trial summary
PROMPT aims at improving management of acute and chronic pain by identifying a core set of PROMs (patient reported outcome measures) that are predictive indicators of treatment success in clinical practice and controlled trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Prospective data collection
- How many people
- 3,322 participants
- Where
- 1 siteGermany
- Study dates
- 24 Sep 2019to 30 Jun 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients undergoing one of the following types of surgery: TKA, breast, sternotomy and endometriosis related surgery. Only female patients will be included in the Breast Surgery and Endometriosis group. For the other surgeries, there will not be a special preference in the distribution by sex or age for the recruitment.
Who may be able to join
- Patient is of consenting age (>18 years old)
- Elective surgery
- Planned stay in hospital for the surgery
- First contact with the patient before surgery
- Patient agrees to participate
Who cannot join
- Patient is unable to give consent
- Cognitive impairment
- Questionnaire is not available in a language the patient is fluent in
- Patient not willing to answer the follow-up questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROMPT Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment A Multicenter, Non-interventional, Prospective Observational Study
PROMPT aims at improving management of acute and chronic pain by identifying a core set of PROMs (patient reported outcome measures) that are predictive indicators of treatment success in clinical practice and controlled trials. These will not only address pain intensities as well as the functional consequences of pain for individuals but also identify patients at risk of experiencing chronification of acute post-operative pain. Results will help health care professionals to individualize pain management, and thus improve the quality of life of pain patients.
Read the detailed description
In order to reach this objective, a non-interventional prospective data collection aiming at reaching a consensus on a core set of PROMs which reliably predict and/or measure success in acute and chronic pain treatments in real life conditions and identifying predictors for chronification of postoperative pain will be conducted (PROMPT NIT-1). Aim of the data collection is to evaluate the abilities of certain PROMs in assessing acute post-surgical pain outcomes in daily routine care of patients after four different surgical procedures: (total knee replacement, breast surgery, sternotomy and surgery related to endometriosis), and to validate selected risk factors for chronification prospectively.
- Conditions
- Pain, Postoperative
- Being tested
- Prospective data collection
- Keywords
- Acute pain, Chronification of pain, Pain treatment, Pain management, Postoperative pain
- Medical subject headings
- Pain, Postoperative, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective data collectionOther
No intervention. It's a prospective data collection.
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty | Patients undergoing total knee arthroplasty Receives: Other: Prospective data collection | |
| Sternotomy | Patients undergoing sternotomy Receives: Other: Prospective data collection | |
| Breast | Patients undergoing breast surgery Receives: Other: Prospective data collection | |
| Endometriosis | Patients undergoing endometriosis-related surgery Receives: Other: Prospective data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
WP 2 - Acute pain: Sensitivity to change
For WP2, the primary endpoint will be pain intensity at day 3 (NRS Scale from 0 to 10, 0 being no pain, 10 being worst pain imaginable). This primary endpoint (PROMs) will be used to assess sensitivity to change from POD3 to POD1.
Measured: 2019 - 2022
WP 3 - Chronification of pain: Incidence of chronic post-surgical pain (CPSP)
For WP3, the primary end point will be the incidence of moderate to severe CPSP (Numeric rating scale ≥ 3/10) at 6 months using the average pain on the Brief Pain Inventory Questionnaire.
Measured: 2019 - 2022
Secondary outcomes (7)
Objective physical activity and sleep, measured with Actigraph devices
Correlation of physical activity data (average no. of steps of days 5 to 7) with PRO "physical function" on day 7;
Measured: 01/2020 to 12/2021
Association between other POD7 PROMs and activity/sleep
Association between other POD7 PROMs and activity/sleep
Measured: 01/2020 to 12/2021
Association between peri-operative processes and activity/sleep
Association between peri-operative processes and activity/sleep
Measured: 01/2020 to 12/2021
Is decreased activity a predictor for chronic postsurgical pain?
Is decreased activity a predictor for chronic postsurgical pain on POM6?
Measured: 01/2020 to 12/2021
Do activity trajectories since surgery parallel trajectories of other outcomes?
Do activity trajectories since surgery parallel trajectories of other outcomes?
Measured: 01/2020 to 12/2021
Correlation of activity difference between POD5-7 and preop with POD7 oucomes
Correlation of activity difference between POD5-7 and preop with POD7 oucomes
Measured: 01/2020 to 12/2021
Association between ambient light intensity and outcomes on POD7
Association between ambient light intensity and outcomes on POD7
Measured: 01/2020 to 12/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start24 Sep 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,322 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Winfried Meissner
- Sponsor type
- University, hospital or other
- Collaborators
- Grünenthal GmbH, University Hospital Muenster, Hospital Ambroise Paré Paris, Novartis Pharmaceuticals, Hôpital Raymond Poincaré, University of Helsinki, University Hospital St Luc, Brussels, Oxford University Hospitals NHS Trust, University Hospital, Geneva, Orthopedic Center Santy, Lyon, France, University of Naples, Hospital Clínico Universitario de Valladolid, Cancer Center Porto, Portugal, Orthopedic Institute Banjika, Belgrade, Serbia, Cardiovascular Center Dedinje, Belgrade, Serbia, University of Homburg, Barts & The London NHS Trust, Insel Gruppe AG, University Hospital Bern, University Hospital Dresden, University Hospital Bergmannsheil Bochum, Infirmerie Protestante de Lyon
- Responsible party
- Sponsor-investigator, Prof. Dr. Winfried Meissner, University of Jena
- Investigators
- Winfried Meissner, Prof., Study chair, Jena University HospitalHiltrud Liedgens, Dr., Study chair, Grünenthal GmbHEsther Pogatzki-Zahn, Prof., Principal investigator, University Hospital MünsterDominique Fletcher, Prof., Principal investigator, Hospital Ambroise Paré ParisShaloo Pandhi, Principal investigator, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834922
- Sponsor's protocol ID
- 777500-IMI-PainCare PROMPT
- Acronym
- PROMPT
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2019
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roper L, Belton J, Weinmann C, Fletcher D, Lavand'homme P, Kalso E, Meissner W, Rosenberger DC, Segelcke D, Vollert J, Pogatzki-Zahn EM. Associations of baseline characteristics, patient-reported outcomes, and satisfaction with pain therapy with the patient's global impression of change: a prospective cohort study. Br J Anaesth. 2026 Apr;136(4):1341-1348. doi: 10.1016/j.bja.2026.01.010. Epub 2026 Feb 13.
PubMed 41690858Vollert J, Egert VM, Segelcke D, Fletcher D, Kalso E, Kemp H, Lavand'homme P, Komann M, Weinmann C, Meissner W, Pogatzki-Zahn EM. Minimal Clinically Important Changes of Patient-reported Outcome Measures for Acute Postsurgical Pain. Anesthesiology. 2026 Jan 1;144(1):143-153. doi: 10.1097/ALN.0000000000005792. Epub 2025 Oct 9.
PubMed 41065659Martinez V, Lehman T, Lavand'homme P, Harkouk H, Kalso E, Pogatzki-Zahn EM, Komann M, Meissner W, Weinmann C, Fletcher D. Chronic postsurgical pain: A European survey. Eur J Anaesthesiol. 2024 May 1;41(5):351-362. doi: 10.1097/EJA.0000000000001974. Epub 2024 Feb 27.
PubMed 38414426Vollert J, Segelcke D, Weinmann C, Schnabel K, Fuchtmann F, Rosenberger DC, Komann M, Maessen T, Sauer L, Kalso E, Fletcher D, Lavand'homme P, Kaiser U, Liedgens H, Meissner W, Pogatzki-Zahn EM. Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study. Br J Anaesth. 2024 Jan;132(1):96-106. doi: 10.1016/j.bja.2023.10.020. Epub 2023 Nov 28.
PubMed 38016907
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMPT Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment A Multicenter, Non-interventional, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03834922
- Acronym / sponsor ID
- PROMPT / 777500-IMI-PainCare PROMPT
- Conditions
- Pain, Postoperative
- Keywords
- Acute pain, Chronification of pain, Pain treatment, Pain management, Postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,322 participants (actual)
- Lead sponsor
- Prof. Dr. Winfried MeissnerUniversity, hospital or other
- Collaborators
- Grünenthal GmbH, University Hospital Muenster, Hospital Ambroise Paré Paris, Novartis Pharmaceuticals, Hôpital Raymond Poincaré, University of Helsinki, University Hospital St Luc, Brussels, Oxford University Hospitals NHS Trust, University Hospital, Geneva, Orthopedic Center Santy, Lyon, France, University of Naples, Hospital Clínico Universitario de Valladolid, Cancer Center Porto, Portugal, Orthopedic Institute Banjika, Belgrade, Serbia, Cardiovascular Center Dedinje, Belgrade, Serbia, University of Homburg, Barts & The London NHS Trust, Insel Gruppe AG, University Hospital Bern, University Hospital Dresden, University Hospital Bergmannsheil Bochum, Infirmerie Protestante de Lyon
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Feb 2019 (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.
PROMPT aims at improving management of acute and chronic pain by identifying a core set of PROMs (patient reported outcome measures) that are predictive indicators of treatment success in clinical practice and controlled trials. These will not only address pain intensities as well as the functional consequences of pain for individuals but also identify patients at risk of experiencing chronification of acute post-operative pain. Results will help health care professionals to individualize pain management, and thus improve the quality of life of pain patients.
Detailed description
In order to reach this objective, a non-interventional prospective data collection aiming at reaching a consensus on a core set of PROMs which reliably predict and/or measure success in acute and chronic pain treatments in real life conditions and identifying predictors for chronification of postoperative pain will be conducted (PROMPT NIT-1). Aim of the data collection is to evaluate the abilities of certain PROMs in assessing acute post-surgical pain outcomes in daily routine care of patients after four different surgical procedures: (total knee replacement, breast surgery, sternotomy and surgery related to endometriosis), and to validate selected risk factors for chronification prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty | – | Other: Prospective data collectionPatients undergoing total knee arthroplasty |
| Sternotomy | – | Other: Prospective data collectionPatients undergoing sternotomy |
| Breast | – | Other: Prospective data collectionPatients undergoing breast surgery |
| Endometriosis | – | Other: Prospective data collectionPatients undergoing endometriosis-related surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing one of the following types of surgery: TKA, breast, sternotomy and endometriosis related surgery. Only female patients will be included in the Breast Surgery and Endometriosis group. For the other surgeries, there will not be a special preference in the distribution by sex or age for the recruitment.
Key inclusion criteria (5 listed)
- Patient is of consenting age (>18 years old)
- Elective surgery
- Planned stay in hospital for the surgery
- First contact with the patient before surgery
- Patient agrees to participate
Key exclusion criteria (4 listed)
- Patient is unable to give consent
- Cognitive impairment
- Questionnaire is not available in a language the patient is fluent in
- Patient not willing to answer the follow-up questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective data collectionNo intervention. It's a prospective data collection. | Other | Breast, Endometriosis, Sternotomy, Total knee arthroplasty |
Primary outcome
WP 2 - Acute pain: Sensitivity to change
Time frame: 2019 - 2022
For WP2, the primary endpoint will be pain intensity at day 3 (NRS Scale from 0 to 10, 0 being no pain, 10 being worst pain imaginable). This primary endpoint (PROMs) will be used to assess sensitivity to change from POD3 to POD1.
WP 3 - Chronification of pain: Incidence of chronic post-surgical pain (CPSP)
Time frame: 2019 - 2022
For WP3, the primary end point will be the incidence of moderate to severe CPSP (Numeric rating scale ≥ 3/10) at 6 months using the average pain on the Brief Pain Inventory Questionnaire.
7 secondary outcomes
Objective physical activity and sleep, measured with Actigraph devices
Time frame: 01/2020 to 12/2021
Association between other POD7 PROMs and activity/sleep
Time frame: 01/2020 to 12/2021
Association between peri-operative processes and activity/sleep
Time frame: 01/2020 to 12/2021
Is decreased activity a predictor for chronic postsurgical pain?
Time frame: 01/2020 to 12/2021
Do activity trajectories since surgery parallel trajectories of other outcomes?
Time frame: 01/2020 to 12/2021
Correlation of activity difference between POD5-7 and preop with POD7 oucomes
Time frame: 01/2020 to 12/2021
Association between ambient light intensity and outcomes on POD7
Time frame: 01/2020 to 12/2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Derived from this study: PubMed 41690858Roper L, Belton J, Weinmann C, Fletcher D, Lavand'homme P, Kalso E, Meissner W, Rosenberger DC, Segelcke D, Vollert J, Pogatzki-Zahn EM. Associations of baseline characteristics, patient-reported outcomes, and satisfaction with pain therapy with the patient's global impression of change: a prospective cohort study. Br J Anaesth. 2026 Apr;136(4):1341-1348. doi: 10.1016/j.bja.2026.01.010. Epub 2026 Feb 13.
- Derived from this study: PubMed 41065659Vollert J, Egert VM, Segelcke D, Fletcher D, Kalso E, Kemp H, Lavand'homme P, Komann M, Weinmann C, Meissner W, Pogatzki-Zahn EM. Minimal Clinically Important Changes of Patient-reported Outcome Measures for Acute Postsurgical Pain. Anesthesiology. 2026 Jan 1;144(1):143-153. doi: 10.1097/ALN.0000000000005792. Epub 2025 Oct 9.
- Derived from this study: PubMed 38414426Martinez V, Lehman T, Lavand'homme P, Harkouk H, Kalso E, Pogatzki-Zahn EM, Komann M, Meissner W, Weinmann C, Fletcher D. Chronic postsurgical pain: A European survey. Eur J Anaesthesiol. 2024 May 1;41(5):351-362. doi: 10.1097/EJA.0000000000001974. Epub 2024 Feb 27.
- Derived from this study: PubMed 38016907Vollert J, Segelcke D, Weinmann C, Schnabel K, Fuchtmann F, Rosenberger DC, Komann M, Maessen T, Sauer L, Kalso E, Fletcher D, Lavand'homme P, Kaiser U, Liedgens H, Meissner W, Pogatzki-Zahn EM. Responsiveness of multiple patient-reported outcome measures for acute postsurgical pain: primary results from the international multi-centre PROMPT NIT-1 study. Br J Anaesth. 2024 Jan;132(1):96-106. doi: 10.1016/j.bja.2023.10.020. Epub 2023 Nov 28.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Winfried Meissner, Prof. study chair
Jena University Hospital
Hiltrud Liedgens, Dr. study chair
Grünenthal GmbH
Esther Pogatzki-Zahn, Prof. principal investigator
University Hospital Münster
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 Pain, Postoperative, run by Prof. Dr. Winfried Meissner at 1 site in Germany.
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: finished, as of the sponsor's last update on 1 Apr 2025. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WP 2 - Acute pain: Sensitivity to change (time frame: 2019 - 2022). 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?
On the ClinicalTrials.gov record for NCT03834922, which also lists 4 linked publications.
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 1 Apr 2025.