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

Completed

• Conditions: Pain, Postoperative
• Interventions: Other: Prospective data collection

• Registration Number: NCT03834922
• Lead Sponsor: Prof. Dr. Winfried Meissner

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.

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 Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-08
• Study Start: 2019-09-24
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3322

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total knee arthroplasty	Prospective data collection	Patients undergoing total knee arthroplasty
Breast	Prospective data collection	Patients undergoing breast surgery
Endometriosis	Prospective data collection	Patients undergoing endometriosis-related surgery
Sternotomy	Prospective data collection	Patients undergoing sternotomy

Primary Outcome Measures

Name	Time	Method
WP 2 - Acute pain: Sensitivity to change	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)	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 Outcome Measures

Name	Time	Method
Objective physical activity and sleep, measured with Actigraph devices	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;
Association between other POD7 PROMs and activity/sleep	01/2020 to 12/2021	Association between other POD7 PROMs and activity/sleep
Association between peri-operative processes and activity/sleep	01/2020 to 12/2021	Association between peri-operative processes and activity/sleep
Is decreased activity a predictor for chronic postsurgical pain?	01/2020 to 12/2021	Is decreased activity a predictor for chronic postsurgical pain on POM6?
Do activity trajectories since surgery parallel trajectories of other outcomes?	01/2020 to 12/2021	Do activity trajectories since surgery parallel trajectories of other outcomes?
Correlation of activity difference between POD5-7 and preop with POD7 oucomes	01/2020 to 12/2021	Correlation of activity difference between POD5-7 and preop with POD7 oucomes
Association between ambient light intensity and outcomes on POD7	01/2020 to 12/2021	Association between ambient light intensity and outcomes on POD7

Trial Locations

Locations (1)

Jena University Hospital; 🇩🇪 Jena, Thuringia, Germany