NCT04318275

Objective Pain Measurement Using a Wearable Biosensor and a Mobile Platform in Patients With Endometriosis

An Early Feasibility Study to Explore a Novel Objective Pain Measurement Using a Wearable Biosensor and a Novel Mobile Platform in Patients With Endometriosis (OPINE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Biofourmis Singapore Pte Ltd. · Industry
• Sex: Female
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore a novel objective measurement for endometriosis-related pain. A variety of pain symptoms are associated with endometriosis, including dysmenorrhea, dyspareunia, dysuria, dyschezia and chronic pelvic pain. However, a clear characterization of pain typology and topology in populations with endometriosis, other gynecologic pathology, or a normal pelvis is lacking. Understanding the precise nature of the relationship between pain and endometriosis is important for the clinical management of affected women, given the body of evidence indicating that medical and surgical management for pain associated with endometriosis has been shown to be effective. Evaluating the relationship between pain and endometriosis, however, is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood. While previous studies have provided important data on the incidence of pelvic pain and endometriosis, little research has been done to assess both the typology and topology of pelvic pain, pain beyond the pelvis, endometriosis diagnosis, or severity of pain using operative findings and a standardized classification system.

Detailed description

BACKGROUND ON ENDOMETRIOSIS A variety of pain symptoms are associated with endometriosis, including dysmenorrhea, dyspareunia, dysuria, dyschezia and chronic pelvic pain. However, a clear characterization of pain typology and topology in populations with endometriosis, other gynecologic pathology, or a normal pelvis is lacking. Understanding the precise nature of the relationship between pain and endometriosis is important for the clinical management of affected women, given the body of evidence indicating that medical and surgical management for pain associated with endometriosis has been shown to be effective. Evaluating the relationship between pain and endometriosis, however, is challenging given that pain is difficult to measure and the mechanism by which endometriosis causes pain is not well understood. While previous studies have provided important data on the incidence of pelvic pain and endometriosis, little research has been done to assess both the typology and topology of pelvic pain, and pain beyond the pelvis, and endometriosis diagnosis and severity using operative findings and a standardized classification system. Historically, pain has been measured using subjective scales to determine the presence of pain and its severity. Common scales include the numeric rating scale (NRS), visual analog scale (VAS), and visual response scale (VRS). While this is important information, self-reporting is a problematic metric for both diagnostic and research purposes as it depends on pain history, cognitive and behavioral factors, and can vary over time. Other measures used in clinical practice, such as the Biberoglu and Behrman (B\&B) score, incorporate both patient and clinician assessments of pain. However, patients describe symptomatology and gynecologists evaluate tenderness and induration during physical examination with an exceedingly high risk of bias and inconsistent reproducibility. Over the past few years, significant advances have been made in the development of valid biomarkers or surrogate markers for the presence and severity of pain. Measurement of various physiology parameters like heart rate, heart rate variability and electrodermal activity have shown to be associated with the presence of pain and can aid clinical interpretation. STUDY RATIONALE Several ratings, such as the numeric rating scale (NRS) are mainly used in clinical trials to determine the presence and severity of pain associated with endometriosis. Patient Reported Outcomes (PRO) such as NRS can be problematic as they are subjective, containing recall bias, and can vary over time. Thus, a more accurate and objective measurement of pain is needed to evaluate the efficacy of treatment with pain associated with endometriosis.

Conditions

• Endometriosis

Timeline

• Start date: 2020-11-06
• Primary completion: 2021-10-28
• Completion: 2022-02-22
• First posted: 2020-03-23
• Last updated: 2022-05-19

Locations

7 sites across 3 countries: United States, Singapore, Taiwan