Recruiting

IOI

Sponsor:

Texas Woman's University

Code:

NCT04851730

Conditions

Pelvic Pain

Chronic Pain

Muscle Tightness

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Orthopedic Physical Therapy Intervention

Dry Needling

Study Details

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). 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.

Conditions

Pelvic Pain

Chronic Pain

Muscle Tightness

Study ID

NCT04851730

Start date

Apr 12, 2021

Status verified date

Apr, 2021

Completion date

Jul 1, 2021

Anticipated

Primary completion date

Jul 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Orthopedic Intervention

All subjects are receiving an orthopedic intervention that is specific to their presentation but made up of all intervention categories: Manual therapy, dry needling, deep breathing, stretching, strengthening, and progressive overload.

Interventions

Orthopedic Physical Therapy Intervention

First, a deep slow breathing protocol is intended to increase the expansion of the pelvic floor, utilizing the relationship between the diaphragm and the pelvic floor, resulting in a gentle stretching of the pelvic floor.

Next, abdominal soft tissue mobilization, or scar mobilization of the lumbopelvic abdominal area will take place.

Next, manual therapy to the thoracic or lumbar spine or the hips will be performed based on the impairments found in the orthopedic evaluation.

The participant will be given a home exercise program to support breath training, and manual therapy. During the initiation of the second visit each participant will watch a standardized pain education video on the tablet, "Understanding pain in less than 5 minutes and what to do about it" The above plan of care will be completed 2 times/week for 4 weeks for a total of 8 visits.

Dry Needling

Third, the investigator will dry needle appropriate muscles. Dry needling treatment technique will include insertion of a sterile, disposable, solid filament needle into the muscle belly in the area palpated as listed below. A 0.30 × 0.50mm, or specified size below, stainless steel Seirin J-type or Myotech needle will be used (Dommerholt 2011). "Clean technique" will be employed throughout the treatment procedure which includes hand washing, clean latex-free glove use, and skin-surface preparation with an alcohol swab ( Baima \& Isaac 2008). Each muscle will receive a maximal number of 2 insertions and each insertion consists of up to 5 seconds of a "pistoning" (in and out motion) technique in an attempt to elicit a local twitch response. Standard protocol for each muscle will be established prior to beginning data collection.

Details about the dry needling protocol can be found in Appendix L.

Primary outcome measure

  • Change in Muscle stiffness pre- and post- dry needling and before and after the whole intervention [ Time Frame: difference between enrollment and end of intervention phase (5 weeks). Difference between end of intervention and end of follow-up (2 weeks), immediately before and after dry needling (2 visits per week, weeks 2, 3, 4, 5 of the study) ]
  • Change in Pain Pressure Threshold, pre- and post- dry needling and before and after the whole intervention [ Time Frame: difference between enrollment and end of intervention phase (5 weeks). Difference between end of intervention and end of follow-up (2 weeks), immediately before and after dry needling (2 visits per week, weeks 2, 3, 4, 5 of the study) ]
  • Change in Numeric Pain Rating scale Pre- and Post- the whole orthopedic intervention [ Time Frame: difference between enrollment and end of intervention phase (5 weeks). Difference between end of intervention and end of follow-up (2 weeks), immediately before and after dry needling (2 visits per week, weeks 2, 3, 4, 5 of the study) ]

Central Contacts and Locations

Central contacts

Laurel E Proulx, DPT

8166995007laurel.proulx@gmail.com

Kelli Brizzolara, PhD

kbrizzolara@twu.edu

Locations

Empower Your Pelvis

Recruiting

Lee's Summit, Missouri, United States, 64063

Contacts

Amanda Fisher, DPT

816-434-5180info@empoweryourpelvis.com

More Information

Sponsor

Texas Woman's University

Last update posted

Apr 20, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Woman's University on 2021-04-20.