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
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 design
Treatments tested in this trial
- Pelvic Floor Muscle Assessment by Near-Infrared Spectroscopy
Treatment groups
Sponsors and collaborators
University of California, Los Angeles
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator