Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04851730
Status:
UNKNOWN
Last Update Posted:
2021-04-20
First Post:
2021-04-12
Brief 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
Sponsor:
Texas Womans University
Organization:
Texas Womans University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 researchers 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 individuals 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 researchers 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 researchers 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 researchers must be in close proximity to the participants eg 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 L1L2 and L4L5 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 5Nsec 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
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 individuals 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 researchers 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 researchers 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 researchers must be in close proximity to the participants eg 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 L1L2 and L4L5 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 5Nsec 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None