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NCT Number: NCT03834922

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jena University Hospital

Jena, Thuringia, 07747, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Prospective data collection

Other

No intervention. It's a prospective data collection.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Objective physical activity and sleep, measured with Actigraph devices

    Time frame: 01/2020 to 12/2021

    Correlation of physical activity data (average no. of steps of days 5 to 7) with PRO "physical function" on day 7;

  2. Association between other POD7 PROMs and activity/sleep

    Time frame: 01/2020 to 12/2021

    Association between other POD7 PROMs and activity/sleep

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

    Time frame: 01/2020 to 12/2021

    Association between peri-operative processes and activity/sleep

  4. Is decreased activity a predictor for chronic postsurgical pain?

    Time frame: 01/2020 to 12/2021

    Is decreased activity a predictor for chronic postsurgical pain on POM6?

  5. Do activity trajectories since surgery parallel trajectories of other outcomes?

    Time frame: 01/2020 to 12/2021

    Do activity trajectories since surgery parallel trajectories of other outcomes?

  6. Correlation of activity difference between POD5-7 and preop with POD7 oucomes

    Time frame: 01/2020 to 12/2021

    Correlation of activity difference between POD5-7 and preop with POD7 oucomes

  7. Association between ambient light intensity and outcomes on POD7

    Time frame: 01/2020 to 12/2021

    Association between ambient light intensity and outcomes on POD7

Sponsors and collaborators

Lead sponsor

Prof. Dr. Winfried Meissner

Other

Collaborators

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

Registry information

Official study title

PROMPT Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment A Multicenter, Non-interventional, Prospective Observational Study

Acronym: PROMPT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2019
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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