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The Effects of Physiotherapeutic Interventions Applied to the Chronic Pelvic Pain Syndrome

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ClinicalTrials.gov Identifier: NCT03755375
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborators:
Beijing Fangshan District Maternal and Children Health Hospital
Guangzhou Women and Children's Medical Center
Dalian Medical University
Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)
Information provided by (Responsible Party):
Clarice Tanaka, University of Sao Paulo General Hospital

Brief Summary:

Related to urological and gynecological systems, patients with Chronic Pelvic Pain Syndrome (CPPS) often present pain, pressure and chronic discomfort in suprapubic and perineal area associated with low urinary tract symptoms. This condition can generates a negative impact in cognitive, social, behavioral and sexual quality of life.

As Chronic Pelvic Pain Syndrome originates from different causes and includes the genitourinary, gastrointestinal, musculoskeletal and neuropsychological systems, a multidisciplinary approach is needed with doctors,physiotherapists, psychologists and others. Physiotherapeutic interventions are recommended as first line of conservative treatment for patients with CPPS. The physiotherapeutic interventions include the use of Biofeedback to relax the pelvic floor muscles, myofascial trigger points release, transcutaneous electrostimulation to decrease the pain and postural exercises to improve the pelvic mobility. Despite of these recommendations, the evidence of the studies in the literature is weak/moderate. There is no consensus related to physiotherapeutic techniques, i.e., the biofeedback devices,the myofascial trigger points techniques, the electrostimulation parameters,the use of postural exercises and short, medium and long term follow up of these patients. The goal of this study is to verify the effects of physiotherapeutic interventions in the treatment of patients with Chronic Pelvic Pain Syndrome (CPPS) and to compare with control group.


Condition or disease Intervention/treatment Phase
Interstitial Cystitis Painful Bladder Syndrome Bladder Pain Syndrome Device: E-stim Behavioral: Postural exercises Not Applicable

Detailed Description:
All patients will be assessed by specialized physiotherapists through a medical history data; application of validated questionnaires of pain, urinary symptoms, sexual function and quality of life; postural evaluation; pelvic floor muscles physical and surface electromyographic assessment at baseline. Patients will be randomized to two different treatment groups and control group. One treatment will be consisted by 10 sessions, once a week, usingBiofeedback , myofascial trigger points release and transcutaneous electrostimulation. The other group will be treated by 10 sessions, once a week, using Biofeedback , myofascial trigger points release and postural exercises.The control group willstart treatment 3 months after the assessment. All patients will be re - evaluated after treatment, at 3, 6 and 12 months' post treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter randomized control trial. All patients will be randomized by the computer (www.random.org) in 4 groups, 2 groups of treatment and 2 control groups. Then, they will be assessed by specialized physiotherapists through a medical history data; application of validated questionnaires of pain, urinary symptoms, sexual function and quality of life; postural evaluation; pelvic floor muscles physical and surface electromyographic assessment at baseline. Patients will be randomized to two different treatment groups and control group. One treatment will be consisted by 10 sessions, once a week, using Biofeedback , myofascial trigger points release and transcutaneous electrostimulation. The other group will be treated by 10 sessions, once a week, using Biofeedback , myofascial trigger points release and postural exercises.The control groups will start treatment 3 months after the assessment. All patients will be re - evaluated after treatment, at 3, 6 and 12 months' post treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Physiotherapeutic Interventions Applied to the Chronic Pelvic Pain Syndrome: A Randomized Control Trial
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : September 3, 2019
Estimated Study Completion Date : September 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
Active Comparator: E-stim Group
The E-stim Group will start treatment after the assessment. Interventions:10 sessions of physiotherapeutic treatment, once a week, using SEMG Biofeedback , myofascial trigger points release and transcutaneous electrostimulation. SEMG Biofeedback device will be applied with vaginal sensors, to assess pelvic floor tenderness and to treat pelvic floor muscles disorders. The myofascial trigger points release will be applied using manual myofascial stretching and relaxation techniques to release the trigger points.The e-stim will be applied during 20 minutes on the sites of pelvic pain to decrease the pain and discomfort (analgesia). Parameters:F=100Hz; Pulse width = 70-100 us and the intensity varies according to the sensitivity of the patient.
Device: E-stim
SEMG Biofeedback applied for relaxation, trigger points release and E-stim to decrease pelvic pain

Active Comparator: Postural Group
The Postural Group will star treatment after the assessment. The interventions will be: 10 sessions of physiotherapeutic treatment, once a week, using SEMG Biofeedback , myofascial trigger points release and postural exercises. SEMG Biofeedback device: It will be applied with vaginal sensors, to assess pelvic floor tenderness and to treat pelvic floor muscles disorders. The myofascial trigger points release will be applied using manual myofascial stretching and relaxation techniques to release the trigger points.The postural exercises will be used to increase the pelvic mobility and stability. Patients will be asked to move the pelvic area in different postures.(lay down, sit down and standing positions).
Behavioral: Postural exercises
SEMG Biofeedback applied for relaxation, trigger points release and postural exercises to improve pelvic mobility to decrease the pelvic pain

Placebo Comparator: E-stim Control Group
The E-stim Control Group will start treatment 3 months after the assessment: 10 sessions of physiotherapeutic treatment, once a week, using SEMG Biofeedback , myofascial trigger points release and transcutaneous electrostimulation. SEMG Biofeedback device will be applied with vaginal sensors, to assess pelvic floor tenderness and to treat pelvic floor muscles disorders. The myofascial trigger points release will be applied using manual myofascial stretching and relaxation techniques to release the trigger points.The e-stim will be applied during 20 minutes on the sites of pelvic pain to decrease the pain and discomfort (analgesia). Parameters:F=100Hz; Pulse width = 70-100 us and the intensity varies according to the sensitivity of the patient.
Device: E-stim
SEMG Biofeedback applied for relaxation, trigger points release and E-stim to decrease pelvic pain

Placebo Comparator: Postural Control Group
The Postural Control Group will start treatment 3 months after the assessment:10 sessions of physiotherapeutic treatment, once a week, using SEMG Biofeedback , myofascial trigger points release and postural exercises. SEMG Biofeedback device: It will be applied with vaginal sensors, to assess pelvic floor tenderness and to treat pelvic floor muscles disorders. The myofascial trigger points release will be applied using manual myofascial stretching and relaxation techniques to release the trigger points.The postural exercises will be used to increase the pelvic mobility and stability. Patients will be asked to move the pelvic area in different postures.(lay down, sit down and standing positions).
Behavioral: Postural exercises
SEMG Biofeedback applied for relaxation, trigger points release and postural exercises to improve pelvic mobility to decrease the pelvic pain




Primary Outcome Measures :
  1. The Effects of Physiotherapeutic Interventions applied to the urinary symptoms [ Time Frame: up to 12 weeks ]
    Change from Baseline in urinary symptoms scores on the PUFF Questionnaire and O´Leary Symptoms and Problems Questionnaire after treatment

  2. The Effects of Physiotherapeutic Interventions applied to the pain symptoms [ Time Frame: up to 12 weeks ]
    Change from Baseline in pain scores on the Visual Analog Scale after treatment


Secondary Outcome Measures :
  1. The Effects of Physiotherapeutic Interventions applied to the sexuality [ Time Frame: up to 12 weeks ]
    Change from Baseline in sexual function score on the FSFI Questionnaire after treatment

  2. The Effects of Physiotherapeutic Interventions applied to the quality of life [ Time Frame: up to 12 weeks ]
    Change from Baseline in general quality of life domain score on the Whoqol - Bref Questionnaire after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants are eligible for this multicenter RCT if they meet the following:

    1. Participant has signed and dated the appropriate Informed Consent document.
    2. Agreed to participate in study procedures.
    3. Participant reports a response of at least 1 on the pain, pressure or discomfort scale.

Participant reports an unpleasant sensation of pain, pressure or discomfort, perceived to be related to the bladder and/or pelvic region, associated with lower urinary tract symptoms for the majority of the time during the last 6 months.

Exclusion Criteria:

  • Individuals will not be eligible for enrollment in the multicenter RCT if they meet any of the criteria listed below:

    1. Oncology patients
    2. Previous pelvic radiotherapy treatment
    3. Systemic or neurological diseases that can compromise the pelvic structures or organs
    4. Patients with cognitive deficiency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755375


Contacts
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Contact: Claudia R. Hacad, MSc 5511 996942249 clahacad@gmail.com

Locations
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Brazil
Universidade de São Paulo Recruiting
Sao Paulo, Brazil, 05403-000
Contact: Clarice Tanaka, PhD         
China, Guangdong
Guangzhou Women and Children´s Medical Center Recruiting
Guangzhou, Guangdong, China
Contact: Liu Huang, MD         
China, Hebei
Beijing Fangshan District Maternal and Children Health Hospital Recruiting
Beijing, Hebei, China
Contact: Chunfang Zou, MD         
China, Liaoning
Dalian Women and Children`s Medical Center Recruiting
Dalian, Liaoning, China
Contact: Zhongmin Wang, MD         
China, Zhejiang
Ningbo Mingzhou Hospital (Affiliated to Zhejiang University) Recruiting
Ningbo, Zhejiang, China
Contact: Qinxian Xu, MD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Beijing Fangshan District Maternal and Children Health Hospital
Guangzhou Women and Children's Medical Center
Dalian Medical University
Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)
Investigators
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Study Director: Clarice Tanaka, PhD University of Sao Paulo
Study Chair: Homero Bruschini, PhD University of Sao Paulo

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Responsible Party: Clarice Tanaka, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03755375     History of Changes
Other Study ID Numbers: 61595016.0.0000.0068
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clarice Tanaka, University of Sao Paulo General Hospital:
Chronic Pelvic Pain Syndrome
Physiotherapy
Biofeedback
Interventions

Additional relevant MeSH terms:
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Syndrome
Somatoform Disorders
Pelvic Pain
Cystitis
Cystitis, Interstitial
Disease
Pathologic Processes
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases