Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment

NCT03834922 | Completed

• 1 other identifier: 777500-IMI-PainCare PROMPT
• Study Type: observational
• Target: 3,322
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain, Postoperative

Keywords

Acute pain; Chronification of pain; Pain treatment; Pain management; Postoperative pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2019 - 2022

Secondary Outcomes (7)

• Objective physical activity and sleep, measured with Actigraph devices

  01/2020 to 12/2021

• Association between other POD7 PROMs and activity/sleep

  01/2020 to 12/2021

• Association between peri-operative processes and activity/sleep

  01/2020 to 12/2021

• Is decreased activity a predictor for chronic postsurgical pain?

  01/2020 to 12/2021

• Do activity trajectories since surgery parallel trajectories of other outcomes?

  01/2020 to 12/2021

Study Arms (4)

Total knee arthroplasty

Patients undergoing total knee arthroplasty

Other: Prospective data collection

Sternotomy

Patients undergoing sternotomy

Other: Prospective data collection

Breast

Patients undergoing breast surgery

Other: Prospective data collection

Endometriosis

Patients undergoing endometriosis-related surgery

Other: Prospective data collection

Interventions

Prospective data collection OTHER

No intervention. It's a prospective data collection.

Breast; Endometriosis; Sternotomy; Total knee arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: For the groups 'Breast' and 'Endometriosis', only female patients can be included.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Winfried Meissner: lead
• Grünenthal GmbH: collaborator
• University Hospital Muenster: collaborator
• Hospital Ambroise Paré Paris: collaborator
• Novartis Pharmaceuticals: collaborator
• Hôpital Raymond Poincaré: collaborator
• University of Helsinki: collaborator
• University Hospital St Luc, Brussels: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• University Hospital, Geneva: collaborator
• Orthopedic Center Santy, Lyon, France: collaborator
• University of Naples: collaborator
• Hospital Clínico Universitario de Valladolid: collaborator
• Cancer Center Porto, Portugal: collaborator
• Orthopedic Institute Banjika, Belgrade, Serbia: collaborator
• Cardiovascular Center Dedinje, Belgrade, Serbia: collaborator
• University of Homburg: collaborator
• Barts & The London NHS Trust: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University Hospital Dresden: collaborator
• University Hospital Bergmannsheil Bochum: collaborator
• Infirmerie Protestante de Lyon: collaborator

Study Sites (1)

Jena University Hospital

Jena, Thuringia, 07747, Germany

Location

Related Publications (2)

• 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.

  PMID: 41065659 DERIVED

• 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.

  PMID: 38414426 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Winfried Meissner, Prof.

  Jena University Hospital

  STUDY CHAIR

• Hiltrud Liedgens, Dr.

  Grünenthal GmbH

  STUDY CHAIR

• Esther Pogatzki-Zahn, Prof.

  University Hospital Münster

  PRINCIPAL INVESTIGATOR

• Dominique Fletcher, Prof.

  Hospital Ambroise Paré Paris

  PRINCIPAL INVESTIGATOR

• Shaloo Pandhi

  Novartis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 8, 2019
• Study Start: September 24, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)