PROMPT
PROMPT Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment A Multicenter, Non-interventional, Prospective Observational Study
Sponsor study identifier
observational
3,322
1 country
1
Study Start
September 24, 2019
Actual (reported)Primary Completion
June 30, 2022
Actual (reported)Study Completion
June 30, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 7, 2019
Actual (reported)February 8, 2019
Actual (reported)September 24, 2019
Actual (reported)June 30, 2022
Actual (reported)June 30, 2022
Actual (reported)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
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
Patients undergoing total knee arthroplasty
Patients undergoing sternotomy
Patients undergoing breast surgery
Patients undergoing endometriosis-related surgery
No intervention. It's a prospective data collection.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Jena University Hospital
Jena, Thuringia, 07747, Germany
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.
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.
Winfried Meissner, Prof.
Jena University Hospital
Hiltrud Liedgens, Dr.
Grünenthal GmbH
Esther Pogatzki-Zahn, Prof.
University Hospital Münster
Dominique Fletcher, Prof.
Hospital Ambroise Paré Paris
3,322 participants (actual enrollment reported by the registry).
First Submitted
February 7, 2019
First Posted
February 8, 2019
Study Start
September 24, 2019
Actual (reported)Gabapentin for Relief of Immediate Postoperative Pain
Contact the study team to confirm eligibility.
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.
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.
Shaloo Pandhi
Novartis
Primary Completion
June 30, 2022
Actual (reported)Study Completion
June 30, 2022
Actual (reported)Last Updated
April 1, 2025
Record last verified: 2025-03
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Source: ClinicalTrials.gov.
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