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

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

Interventions

PROCEDURE

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.

DEVICE

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.

Sponsors & Collaborators

• Texas Woman's University

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-12

Primary Completion

2021-07-01

Completion

2021-07-01

FDA Device

Yes

Countries

• United States

Study Locations