Clinical trial NCT04851730: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Pain
Chronic Pain
Muscle Tightness
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: ABA single subject design
Primary purpose: TREATMENT

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.

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 physical therapy care. If the patient is interested they will be given the researcher's email address and phone number to make appropriate arrangements. Once the potential participant contacts the researcher they will take part in a prescreening phone call. This prescreening call will assess their willingness to enroll in the study and ask preliminary inclusion criteria. This prescreening is necessary to allow participants to be taken off of the therapists' regular schedule and go onto the research schedule, allowing therapists to fill vacancies in their schedule if appropriate. If a participant emails or leaves a message, the researcher can call them to initiate the prescreening phone call. Potential subjects will be called a maximum of 2 times and up to 2 messages will be left for any potential subject that voiced interest by initiating contact with the researcher.

If the individual does not wish to participate after hearing more details from the researcher or for some reason does not meet inclusion criteria, the only information collected from the prescreening phone call will be gender, age, race, ethnicity, and reason for exclusion so that the number of patients that were screened compared to the number of patients that were enrolled, per the CONSORT guidelines, can be tracked. No further data will be collected or recorded from this call as it is intended to assess interest level and inform potential subjects that they will be scheduling with a researcher instead of a clinician. Individuals who contact researchers showing interest in the study from physician referral will also provide their contact information in order to schedule their first appointment with the researchers.

The information collected for prescreening or scheduling will only be shared with a small group of researchers in an encrypted file on a password protected computer. This file will be saved separately from any data collected by the study of enrolled participants. Enrolled subjects will be coded with a participant number as to not cross-identify with any record of contact information saved with the individual's name.

An ABA single-subject research design will be used for this study. Participants will undergo 3-5 sessions of baseline testing based on the stabilization of the dependent variable, with two visits per week until stabilization. If stabilization of two of the three dependent variables (NPRS, muscle stiffness, and PPT) can not be met then the participant cannot continue into the intervention phase of the study. Then the participants will undergo four weeks of intervention, two times a week for a total of 8 intervention appointments. Dependent variables will be collected one and two weeks after the last intervention ends to establish if there is a continuation of the data trend without intervention taking place.

15 women with CPP will be recruited as previously discussed. The participant will also be asked to wear a mask during the testing procedures and wash your hands before starting the session. First, we will take the participants temperature and ask if they have any symptoms of COVID-19, prior to each appointment. The researcher(s) will wash their hands with soap using methods recommended by the CDC before and after the research sessions. If hand washing is not available, we will use and ask them to use hand sanitizer. The researchers will also limit the number of research team members present to one treating member.

Unfortunately hands on intervention does not allow for social distancing. The researchers will conduct the study in a time efficient manner to minimize their time at the research site. The researcher(s) will wear masks during the entire study. If needed, the researchers will wear other PPE (personal protective equipment) such as laboratory coats or gowns, gloves, and eye protection during the study. When the researcher(s) must be in close proximity to the participants (e.g., performing the screening exam, performing manual therapy or dry needling), the researchers will have a face shield in addition to a mask.

After the participant has met inclusion and exclusion criteria and is enrolled in the study by Investigator #1, the participant will answer demographic and health history (Appendix A), pain, (Appendix B and C), psychosocial (Appendix F and G) and function and disability outcome measures (Appendix E). Next, Investigator #2 will perform a pelvic floor muscle assessment (Appendix D) in a private room at the consent of the participant and after informing the participant of the entire exam. Clean technique will be used with the therapist using one gloved finger with lubrication. The therapist will visually observe automatic and volition actions of shortening and lengthening of the pelvic floor and intra-vaginally manually assess the muscle strength of the superficial muscles consistent with the International Continence Society muscle grading system. Then the levator ani muscles will be assessed for power and endurance. All pelvic floor muscle measurements will be taken at each visit in the baseline and intervention phases, but will not be used as an outcome measure that determines stabilization.

Muscle stiffness measurements (Appendix C) will be collected using the MyotonPro by Investigator #1. MyotonPro measurements will be collected in the same order for each person to ensure similar resting time of each muscle. Testing will be done on the rectus femoris, adductor longus, lumbar paraspinals at levels L1/L2 and L4/L5 and the piriformis as these muscles were previously found to be significantly more stiff in those with CPP as compared to those without pelvic pain. Measurements of the individual muscles will be acquired on the more painful side if the participant is able to identify one, or by drawing a previously randomized card to determine the side of measurement. All measurements will be taken with the limb supported in a resting state. One measurement will be taken at each muscle due to previously acquired reliability measures. This measurement will establish if muscular stiffness is over 1 standard deviation (SD) above the average stiffness of a person without CPP, per muscle. If the person does have stiffness over 1SD, then dry needling will be performed on that muscle during the intervention phase of the study.

Next, PPT measurements (Appendix C) will be taken to assess local sensitivity to pain and pressure to measure changes in central sensitization over time at all muscle sites. PPT will also be assessed directly after dry needling is performed in the intervention phase. PPT measurements will be taken at all muscle sites, even if they do not meet the threshold to perform dry needling. A digital pressure algometer (Wagner Force Ten FDX, Wagner Instruments, Greenwich, CT) will be used to assess PPT. The algometer will be held by an examiner directly perpendicular to the muscle belly of and advanced at a rate of approximately 5N/sec. Participants will be instructed to verbally signal when they first perceive the force exerted as painful or uncomfortable.

After baseline measurements of pelvic floor muscle assessment, muscle stiffness, and PPT are complete, Investigator #1 will perform a standard lumbopelvic orthopedic exam (Appendix I). Based upon the preliminary MyotonPro testing and the orthopedic exam the intervention will be planned. This study is intended to replicate an individualized orthopedic plan of care using an impairment-based approach during the physical therapy evaluation. Since the intervention is based on what is found in the evaluation there is some discernment left up to the therapist. Standards will be established for each section of the orthopedic assessment in order to standardize which patient presentation gets what intervention as shown in Appendix J. The same order of care will be followed for each participant as well. Appendix J shows the possible interventions that can be performed based on each region of the evaluation. Documentation of the intervention and dosage will be recorded for each participant at each appointment.

The participants will be seen 2 times a week for 4 weeks for the intervention phase of the the A-B-A design.

Following the intervention portion of the study, the participant will come back for further dependent variable testing without intervention. The participant will return 1 time per week for 2 weeks. Measurements of PPT, muscle stiffness, NPRS, and pelvic floor and orthopedic function measurements will be taken at each visit through all phases of the study. Questionnaires such as the PFDI, CSI and BDI will be taken at the first baseline visit, last intervention visit and last follow-up visit since we do not expect these outcome measures to change from visit to visit.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Muscle stiffness pre- and post- dry needling and before and after the whole intervention
timeFrame: 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)
measure: Change in Pain Pressure Threshold, pre- and post- dry needling and before and after the whole intervention
timeFrame: 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)
measure: Change in Numeric Pain Rating scale Pre- and Post- the whole orthopedic intervention
timeFrame: 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:
measure: Change in Subjective Pelvic floor muscle function Pre- and Post- the whole orthopedic intervention
timeFrame: difference between enrollment and end of intervention phase (5 weeks). Difference between end of intervention and end of follow-up (2 weeks)
Other outcomes:
measure: Change in Pelvic Floor muscle function via intervaginal examination
timeFrame: difference between enrollment and end of intervention phase (5 weeks). Difference between end of intervention and end of follow-up (2 weeks)
measure: Change in Pelvic Floor muscle function via intervaginal examination
timeFrame: difference between enrollment and end of intervention phase (5 weeks). Difference between end of intervention and end of follow-up (2 weeks)
measure: Change in Pelvic Floor muscle function via intervaginal examination
timeFrame: difference between enrollment and end of intervention phase (5 weeks). Difference between end of intervention and end of follow-up (2 weeks)
Locations:
city: Lee's Summit
country: United States
facility: Empower Your Pelvis
state: Missouri
Study officials:
References:
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