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NCT02329574 · ClinicalTrials.gov registry record

Prediction of Persistent Post-Mastectomy Pain

A clinical trial, sponsored by Brigham and Women's Hospital.

Completed
Registry status
259
Enrollment target

NCT02329574 is a clinical trial that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 259 participants.

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The verdict

NCT02329574 has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
259 participants
Enrollment target

Study Summary

Chronic pain is devastating both to individuals and society. In an aging population, surgery is an increasing cause of chronic pain, with rates of persistent post-operative pain ranging from 10-65%.In particular, Persistent Post-Mastectomy Pain (PPMP) occurs in roughly one third of women who have had mastectomy. The occurrence of PPMP does not seem to be strongly determined by the type of surgery, chemotherapy, and radiation treatment, suggesting that individual person-specific factors may play a more important role. In fact, recent studies indicate that individual differences in pain sensitivity (psychophysics) are more closely associated with PPMP than surgical/medical variables. Specifically, sensory testing revealed that women who developed PPMP had lower pressure pain thresholds and greater temporal summation of pain stimuli than women who did not develop this chronic pain condition. Moreover, psychosocial factors such as anxiety, depression, catastrophizing, and somatization were more prominent in women with PPMP. These preliminary, retrospective studies suggest that individual psychophysical and psychosocial characteristics could be important risk factors for PPMP. Accordingly, the aim of this study is to comprehensively and prospectively study women having mastectomy surgery, to determine the relationship between pre-operative psychophysical and psychosocial factors and the development of PPMP. Using these data, a prediction model for PPMP will be developed, thus allowing a preoperative calculation of a "PPMP risk score" for any patient facing mastectomy.

Trial Details

FieldValue
Enrollment Target 259 participants
Start Date 2014-10
Est. Completion 2018-10

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT02329574

The ClinicalTrials.gov registry entry for NCT02329574 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 259 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT02329574 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02329574 about?

NCT02329574 is a clinical study titled "Prediction of Persistent Post-Mastectomy Pain". Chronic pain is devastating both to individuals and society. In an aging population, surgery is an increasing cause of chronic pain, with rates of persistent post-operative pain ranging from 10-65%.In particular, Persistent Post-Mastectomy Pain (PPMP) occurs in roughly one third of women who have ha...

What is the current status of trial NCT02329574?

This trial is currently completed. The enrollment target is 259 participants. The study started on 2014-10. Estimated completion is 2018-10.

Who is sponsoring clinical trial NCT02329574?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.