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.
