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

NCT04851730 | Unknown FDA Device

• 1 other identifier: FY2021-144
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Change in Muscle stiffness pre- and post- dry needling and before and after the whole intervention

  Using the MyotonPro peripheral muscles stiffness will be measures. Higher Nm equals more stiffness

  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

  Use a pressure algometer to test sensitivity to pressure. Less pressure equals more sensitivity.

  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

  subjective outcome measure rating average pain through the week. Scale of 0-10 with 0 being no pain and 10 being the worst pain imaginable.

  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)

Secondary Outcomes (1)

• Change in Subjective Pelvic floor muscle function Pre- and Post- the whole orthopedic intervention

  difference between enrollment and end of intervention phase (5 weeks). Difference between end of intervention and end of follow-up (2 weeks)

Other Outcomes (3)

• Change in Pelvic Floor muscle function via intervaginal examination

  difference between enrollment and end of intervention phase (5 weeks). Difference between end of intervention and end of follow-up (2 weeks)

• Change in Pelvic Floor muscle function via intervaginal examination

  difference between enrollment and end of intervention phase (5 weeks). Difference between end of intervention and end of follow-up (2 weeks)

• Change in Pelvic Floor muscle function via intervaginal examination

  difference between enrollment and end of intervention phase (5 weeks). Difference between end of intervention and end of follow-up (2 weeks)

Study Arms (1)

Orthopedic Intervention

EXPERIMENTAL

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.

Procedure: Orthopedic Physical Therapy Intervention; Device: Dry Needling

Interventions

Orthopedic Physical Therapy Intervention PROCEDURE

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.

Also known as: manual therapy, mobility, deep breathing, graded exposure, therapeutic exercise

Orthopedic Intervention

Dry Needling DEVICE

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.

Orthopedic Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: For the purposes of this study and to reduce the number of variables within the study that could contribute to pelvic pain, woman is defined as an individual who was identified as female at birth based on genitalia and currently identifies as female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.
• 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)
• 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

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

Empower Your Pelvis

Lee's Summit, Missouri, 64063, United States

RECRUITING

Related Publications (10)

• Baker PK. Musculoskeletal origins of chronic pelvic pain. Diagnosis and treatment. Obstet Gynecol Clin North Am. 1993 Dec;20(4):719-42.

  PMID: 8115087 RESULT

• Bizzini M, Mannion AF. Reliability of a new, hand-held device for assessing skeletal muscle stiffness. Clin Biomech (Bristol). 2003 Jun;18(5):459-61. doi: 10.1016/s0268-0033(03)00042-1.

  PMID: 12763442 RESULT

• Coronado RA, Bialosky JE. Manual physical therapy for chronic pain: the complex whole is greater than the sum of its parts. J Man Manip Ther. 2017 Jul;25(3):115-117. doi: 10.1080/10669817.2017.1309344. Epub 2017 Jun 12. No abstract available.

  PMID: 28694673 RESULT

• Dommerholt J. Dry needling - peripheral and central considerations. J Man Manip Ther. 2011 Nov;19(4):223-7. doi: 10.1179/106698111X13129729552065.

  PMID: 23115475 RESULT

• Jafari H, Courtois I, Van den Bergh O, Vlaeyen JWS, Van Diest I. Pain and respiration: a systematic review. Pain. 2017 Jun;158(6):995-1006. doi: 10.1097/j.pain.0000000000000865.

  PMID: 28240995 RESULT

• Kinser AM, Sands WA, Stone MH. Reliability and validity of a pressure algometer. J Strength Cond Res. 2009 Jan;23(1):312-4. doi: 10.1519/jsc.0b013e31818f051c.

  PMID: 19130648 RESULT

• Loving S, Thomsen T, Jaszczak P, Nordling J. Pelvic floor muscle dysfunctions are prevalent in female chronic pelvic pain: a cross-sectional population-based study. Eur J Pain. 2014 Oct;18(9):1259-70. doi: 10.1002/j.1532-2149.2014.485.x. Epub 2014 Apr 3.

  PMID: 24700500 RESULT

• Maher RM, Hayes DM, Shinohara M. Quantification of dry needling and posture effects on myofascial trigger points using ultrasound shear-wave elastography. Arch Phys Med Rehabil. 2013 Nov;94(11):2146-50. doi: 10.1016/j.apmr.2013.04.021. Epub 2013 May 14.

  PMID: 23684553 RESULT

• Neville CE, Fitzgerald CM, Mallinson T, Badillo S, Hynes C, Tu F. A preliminary report of musculoskeletal dysfunction in female chronic pelvic pain: a blinded study of examination findings. J Bodyw Mov Ther. 2012 Jan;16(1):50-6. doi: 10.1016/j.jbmt.2011.06.002. Epub 2011 Jul 6.

  PMID: 22196427 RESULT

• Proulx L, Brizzolara K, Thompson M, Wang-Price S, Rodriguez P, Koppenhaver S. Women with Chronic Pelvic Pain Demonstrate Increased Lumbopelvic Muscle Stiffness Compared to Asymptomatic Controls. J Womens Health (Larchmt). 2023 Feb;32(2):239-247. doi: 10.1089/jwh.2022.0198. Epub 2022 Nov 25.

  PMID: 36450120 DERIVED

MeSH Terms

Conditions

Pelvic Pain; Chronic Pain

Interventions

Musculoskeletal Manipulations; Range of Motion, Articular; Exercise Therapy; Dry Needling

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care

Central Study Contacts

Laurel E Proulx, DPT

CONTACT

8166995007; laurel.proulx@gmail.com

Kelli Brizzolara, PhD

CONTACT

kbrizzolara@twu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The researcher providing the orthopedic intervention will be blinded from the participant's pelvic floor muscle examination results.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: ABA single subject design

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 20, 2021
• Study Start: April 12, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)