Objective Pain Measurement Using a Wearable Biosensor and a Mobile Platform in Patients With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

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.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        124 study participants, aged between 21 to 50 years old, female, who is confirmed diagnosis
        of endometriosis.