Status:
UNKNOWN
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
Lead Sponsor:
Texas Woman's University
Conditions:
Pelvic Pain
Chronic Pain
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
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...
Detailed Description
When patients make their initial appointment at the private outpatient pelvic health office, they will be informed about a study looking for participants with pelvic pain that includes 4 weeks of free...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04851730
Start Date
April 12 2021
End Date
July 1 2021
Last Update
April 20 2021
Active Locations (1)
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1
Empower Your Pelvis
Lee's Summit, Missouri, United States, 64063