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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Germany1 site

  • Jena University Hospital

    Jena, Thuringia, 07747

Other trials in Germany

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.

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 groups in NCT03834922
Study groupRoleWhat they receive
Total knee arthroplastyPatients undergoing total knee arthroplasty
Receives: Other: Prospective data collection
SternotomyPatients undergoing sternotomy
Receives: Other: Prospective data collection
BreastPatients undergoing breast surgery
Receives: Other: Prospective data collection
EndometriosisPatients 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.

  1. 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

  2. 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)

  1. 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

  2. Association between other POD7 PROMs and activity/sleep

    Association between other POD7 PROMs and activity/sleep

    Measured: 01/2020 to 12/2021

  3. Association between peri-operative processes and activity/sleep

    Association between peri-operative processes and activity/sleep

    Measured: 01/2020 to 12/2021

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted8 Feb 2019
  2. Study start24 Sep 2019
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

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
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 41690858

  • Vollert 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 41065659

  • Martinez 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 38414426

  • Vollert 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

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.

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