NIRS for the Diagnosis of Myofascial Pelvic Pain

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women between 18 and 100 years of age

Pelvic pain for more than 6 months duration

Report an average daily pain intensity score of at least 4 (on a 0 to 10 scale)

Palpable trigger/tender points in internal pelvic floor muscles on standardized myofascial pelvic floor exam

Disqualifiers

Inability to participate in clinic visits

Prior invasive pelvic procedures for pain (e.g., prior pelvic surgery, sacral neuromodulation, intradetrusor Botox®)

Active UTI or vaginal infection

Pregnancy, childbirth during the previous 12 months, currently planning pregnancy

Trial population

The control subjects (cohort 1) will be adult 18 (\>18 years of age) who lack pelvic pain or other genitourinary symptoms. The MPP cohort (cohort 2) will consist of adult women \>18 years of age with pelvic floor muscle pain or tender points.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Control Subjects1 intervention
Group B: Myofascial Pelvic Pain Subjects1 intervention

Trial outcomes

Primary outcomes

1

MPP Diagnosis

Accurate Diagnosis of Myofascial Pelvic Pain

Time frame
1 day

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator