The Effect of an Individualized Impairment-based, Orthopedic Physical Therapy Intervention (IOI), on Muscle Stiffness, Pelvic Floor Function, and Pain in Women With Chronic Pelvic Pain

Status unconfirmed · Not applicable

Conditions studied: Pelvic Pain, Chronic Pain, Muscle Tightness

In brief

The primary purpose of this study is to establish if an individualized, impairment-based orthopedic intervention (IOI) can improve pelvic floor function and pain in women with Chronic Pelvic Pain (CPP). Dry needling will be used as a part of the IOI to intervene upon peripheral muscles stiffness previously found to be more stiff in this population compared to healthy controls. This study is intended to initiate a line of research aimed at assessing widely used orthopedic physical therapy practices to address orthopedic impairments and muscle stiffness differences in women with CPP potentially decreasing time to care for a widely experienced condition. This study will guide potential future studies aimed at intervening upon a larger population and establishing the characteristics of participants who respond favorable to orthopedic care alone. First, this study will establish if this type of intervention has an effect on pelvic floor function and symptoms, pain, and muscle stiffness, all of which are often priorities of treatment for PHPTs treating CPP. A single-subject design is well suited in studying an intervention on such a heterogeneous patient population that does not currently have physical therapy treatment subclassifications. Future studies could help to establish possible subclassifications of CPP to include an orthopedic or peripheral muscle stiffness classification and empower therapists with associations between peripheral orthopedic and myofascial dysfunction and pelvic floor function and pain. This line of research could help prioritize which patients require specialty care, who could initiate care with an orthopedic PT, and who may resolve dysfunction and pain with orthopedic PT alone.

Key facts

Study ID: NCT04851730
Run by: Texas Woman's University
People needed: 15
Starts: 2021-04-12
Expected to finish: 2021-07-01
Last updated by the study team: 2021-04-20

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

identified as female at birth and currently identifies as female
between the ages of 18 and 50
self identified pelvic pain for over 3 months and currently experiencing pain in the last week
pain is non-cyclical in nature
pain is located between the ilium, the umbilicus and pubic bone to include the vulva.
(Speer et al. 2016)

You may not qualify if…

Participants will be excluded if they are experiencing pain due to reasons that are known to be inappropriate for orthopedic treatment such as acute fracture or malignancy, have a systemic condition which effects muscle stiffness measurements or meets a criteria that would change the validity or reliability of instrumentation, or have a medically serious reason for pelvic pain to include infection or neoplasm.
Exclusion criteria includes:
body mass index >31(Bizzini \& Mannion 2003)
recent [3 month] history of pelvic surgery
history of systemic inflammatory disease
known pregnancy
inability to lie prone, side and/or back for positioning of MyotonPro measurements or dry needling
Inability to read and understand English
current infection or neoplasm
history of radiation therapy to any of the tissues being measured, (Lawrence et al. 2012)
current fracture of lumbar spine, pelvis, hips or lower extremity
received dry needling, injections, or soft-tissue mobilization of areas being measured within the past 4 weeks
less than 6 months postpartum (Romano et al. 2010)
Additional exclusion criteria has been added due to the dry needling intervention. Exclusion criteria pertaining to dry needling includes:
not giving consent to dry needling, having a needle phobia
having a history of negative reaction to needling (or injection) in the past
using anticoagulant therapy
needling into an area or limb with lymphoedema as patients with lymphoedema may be more susceptible to infection
abnormal bleeding tendency, thrombocytopenia,
immunocompromised patients from disease (e.g. Blood borne disease, Cancer, HIV, AIDS, Hepatitis, bacterial endocarditis, incompetent heart valve or valve replacements etc.)
immunocompromised from immunosuppression therapy or on cancer therapy
acute immune disorders (E.G. acute states of rheumatoid arthritis, current infection, local or systemic etc.)
has vascular Disease
has epilepsy

Where it is running

Empower Your Pelvis — Lee's Summit, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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