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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03755375

Collaborator

Beijing Fangshan District Maternal and Children Health Hospital (Other), Guangzhou Women and Children's Medical Center (Other), Dalian Women and Children's Medical Center (Other), Ningbo Mingzhou Hospital (Affiliated to Zhejiang University) (Other)

Enrollment

Locations

Arms

36.3

Anticipated Duration (Months)

5.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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.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 :

Sep 5, 2017

Anticipated Primary Completion Date :

Sep 3, 2019

Anticipated Study Completion Date :

Sep 14, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

The Effects of Physiotherapeutic Interventions applied to the urinary symptoms [up to 12 weeks]
Change from Baseline in urinary symptoms scores on the PUFF Questionnaire and O´Leary Symptoms and Problems Questionnaire after treatment
The Effects of Physiotherapeutic Interventions applied to the pain symptoms [up to 12 weeks]
Change from Baseline in pain scores on the Visual Analog Scale after treatment

Secondary Outcome Measures

The Effects of Physiotherapeutic Interventions applied to the sexuality [up to 12 weeks]
Change from Baseline in sexual function score on the FSFI Questionnaire after treatment
The Effects of Physiotherapeutic Interventions applied to the quality of life [up to 12 weeks]
Change from Baseline in general quality of life domain score on the Whoqol - Bref Questionnaire after treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Participant has signed and dated the appropriate Informed Consent document.
Agreed to participate in study procedures.
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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade de São Paulo	Sao Paulo		Brazil	05403-000
2	Guangzhou Women and Children´s Medical Center	Guangzhou	Guangdong	China
3	Beijing Fangshan District Maternal and Children Health Hospital	Beijing	Hebei	China
4	Dalian Women and Children's Medical Center	Dalian	Liaoning	China
5	Ningbo Mingzhou Hospital (Affiliated to Zhejiang University)	Ningbo	Zhejiang	China