NIRS for the Diagnosis of Myofascial Pelvic Pain

Conditions

• Myofascial Pelvic Pain

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Pelvic Floor Muscle Assessment by Near-Infrared Spectroscopy — DIAGNOSTIC_TEST
  This study will develop and test an instrument to establish a normal range for near infrared spectroscopy (NIRS) optical changes associate with pelvic floor exercise in adult women based on the test-to test (intra-day) reliability of oxygen kinetics related to contraction of the pelvic floor muscle. We will establish the relationship between the quantitative NIRS data, the condition of Myofascial pelvic musculature and the symptomatology of MPP and related comorbidities. We will also evaluate prospectively the effectiveness of these data in predicting effective treatment modalities. Finally, we will optimize a training regime for non-specialists to allow this technique to be used in a variety of settings. The development of this device and validation of its relevance to diagnosis and treatment of MPP will provide effective care sooner and at a lower cost than current procedures. It will also reduce inequities in the availability of care to underserved populations.

Study Details

Myofascial Pelvic Pain (MPP) is an often-misdiagnosed condition affecting up to 26% of women during their lives and imposing enormous costs on national health care systems. It frequently involves comorbidities such as bladder, bowel, and sexual dysfunction. There are no quantitative measures that adequately guide the physician and accurate diagnosis typically requires an internal examination by a tertiary specialist. This study will develop and test an instrument to establish a normal range for near infrared spectroscopy (NIRS) optical changes associate with pelvic floor exercise in adult women based on the test-to test (intra-day) reliability of oxygen kinetics related to contraction of the pelvic floor muscle. We will establish the relationship between the quantitative NIRS data, the condition of Myofascial pelvic musculature and the symptomatology of MPP and related comorbidities. We will also evaluate prospectively the effectiveness of these data in predicting effective treatment modalities. Finally, we will optimize a training regime for non-specialists to allow this technique to be used in a variety of settings. The development of this device and validation of its relevance to diagnosis and treatment of MPP will provide effective care sooner and at a lower cost than current procedures. It will also reduce inequities in the availability of care to underserved populations by providing an inexpensive, reliable and easily available method for a variety of providers to address MPP.

Key Dates

Start date

Jan 23, 2025

Status verified

Sep 2025

Primary completion

Jul 1, 2026

Completion

Sep 1, 2026

Study Design

Enrollment

110 participants (estimated)

Arms

• Arm: Control Subjects
  Women age 18 or older without pelvic pain or other genitourinary complaints
• Arm: Myofascial Pelvic Pain Subjects
  Women age 18 or older with pelvic floor muscle pain or tender points

Primary Outcome Measure

MPP Diagnosis [ Time Frame: 1 day ]

Central Contacts

• Keila Kimura
  310-794-5910
  [email protected]

Locations (1)

Find similar trials in Los Angeles, CA

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