跳至主要内容
临床试验/NCT04851730
NCT04851730Unknown不适用

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

Texas Woman's University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年4月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
15
试验地点
2
主要终点
Change in Numeric Pain Rating scale Pre- and Post- the whole orthopedic intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The researcher providing the orthopedic intervention will be blinded from the participant's pelvic floor muscle examination results.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Change in Numeric Pain Rating scale Pre- and Post- the whole orthopedic intervention

时间窗: 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)

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.

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

时间窗: 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)

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

Change in Pain Pressure Threshold, pre- and post- dry needling and before and after the whole intervention

时间窗: 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)

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

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurel Proulx

Principal Investigator

Texas Woman's University

研究点 (2)

Loading locations...

相似试验