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Telerehabilitation in Chronic Pelvic Pain (CPP)

Primary Purpose

Pelvic Pain, Telerehabilitation, Pelvic Floor; Relaxation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation Treatment
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: experienced pelvic pain (dyspareunia) for over six (6) months prior to the study to be able to use the internet and their willingness to participate. no pelvic floor surgeries no C-section and birth history to have a diagnoses by dyspareunia Exclusion Criteria: to have endometriosis to have a pelvic health physiotherapy history pelvic organ prolapse, or a previous pelvic organ surgery. the use of analgesics in the previous three (3) months, to have a pregnancy, to have an active vaginal or urinary tract infection, or suffering from other comorbidities that affect the lower urinary tract such as diabetes mellitus

Sites / Locations

  • Alime BuyukRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telerehabilitation group

Education group

Arm Description

Multimodal self-treatment-based telerehabilitation will be implemented with a video conference method. For telerehabilitation, at each session, manual therapy techniques, (i.e., stretching, myofascial release, and tissue desensitization), sex education, and pelvic floor muscle relaxation massages with a pelvic wand (i.e., relaxation, stretching) using small intra-vaginal wand were used. Women were also asked to perform home exercises resembling those performed under supervision five times per week as well as auto-insertion exercises with a pelvic wand in addition to desensitization techniques three times per week. Sessions consist of 60 minutes. Telerehabilitation will take place 2 days a week for 12 weeks.

60 minutes of video recording training will be given about pelvic pain relaxation exercises.

Outcomes

Primary Outcome Measures

Pelvic Pain Impact Questionnaire
The Pelvic Pain Impact Questionnaire is a questionnaire composed of eight (8) questions. The patient is asked to grade how pelvic pain has affected various activities on a 5-point Likert scale. The total score is obtained by adding the scores given for each item, a high score is directly proportional to the severity of pain.
VAS
The VAS is frequently used in cases where rapid measurement of pain intensity is required in clinical and laboratory conditions. It consists of drawing a line from zero (0) to ten (10) and ask the patient to mark the pain intensity on the line where zero (0) means "I have no pain" and ten (10) means "the most severe pain possible".
The Female Sexual Function Index
The Female Sexual Function Index is a brief multidimensional scale for assessing sexual function in women. The scale has received initial psychometric evaluation, including studies of reliability, convergent validity, and discriminant validity
The Female Sexual Distress Scale-Revised
The Female Sexual Distress Scale-Revised was used to assess sexual distress, with higher scores relating to more sexual distress
Vaginal Penetration Cognition Questionnaire
To assess cognition regarding vaginal penetration in women with vaginismus or dyspareunia

Secondary Outcome Measures

The Patient Global Impression of Change
The Patient Global Impression of Change allowed the participants to self-report their perceived improvement (categories ranging from very much improved to very much worse). The PGI-I requires the patient to grade on a seven (7) point likert scale how the condition has evolved compared to how it was prior to the treatment. All questionnaires have validity and reliability in Turkish language .

Full Information

First Posted
January 16, 2023
Last Updated
January 25, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05698355
Brief Title
Telerehabilitation in Chronic Pelvic Pain
Acronym
CPP
Official Title
Telerehabilitation in Chronic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
January 16, 2023 (Actual)
Study Completion Date
May 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: Physical therapists utilize telerehabilitation as the common term for telehealth applications. Many physiotherapists worked as telehealth providers during the coronavirus pandemic. The objective of the study will show the efficacy of Telerehabilitation-Based Physical Therapy (TBPT) on pain intensity and treatment satisfaction in patients with chronic pelvic pain. Method: This study is a prospective study of patients with chronic pelvic pain.42 participants will include the study. Patients who have any other distribution pattern of pelvic pain were equally considered for therapy. Women age between 18-50 years will be include. Their symptoms should be one of these follows such as chronic pain in pelvic region, hyperalgesia in vulva, and pain during sitting or intercourse. They will get diagnosed by a gynecologist who is a multidisciplinary team comprising and referred to a pelvic health physiotherapist. Prior to treatment patients will complete questionnaires and interview a pelvic health physiotherapist. Pain symptoms will be assessed with the Visual Analog Scale (VAS) and The Pelvic Pain Impact Questionnaire (PPIQ) before and after treatment. Patient Global Impression of Improvement (PGI-I) for evaluating patient satisfaction after treatment. Women with chronic pelvic pain will be treated for 16 sessions (an hour for each session) in 8 weeks with the TBPT technique by the same pelvic health physiotherapist (AB). Patients will apply internal and external trigger point release therapy and self-massage techniques by themselves with Telerehabilitation-Based Physical Therapy.
Detailed Description
Telerehabilitation is described as the remote conveyance of healthcare services and clinical information using information and telecommunication technologies involving the internet, wireless satellite, and telephone media to provide a series of rehabilitation services by eliminating the barriers of distance, time, and travel to receive care. There is an abundance of commercially available applications (such as Zoom) offered for health care monitoring and management. Most of the studies have employed telerehabilitation methods with patients who have pain, mainly for assessment or exercise programs. There is not any study on the telerehabilitation application of physical therapy in patients with chronic pelvic pain during the coronavirus pandemic. Our conceptual framework is based on two arguments. First, physiotherapists need physical access to their patients only for a limited number of interventions. Most of the methods used by physiotherapists to treat their patients can be conducted at a distance without having direct access to the patient. Previous studies have shown that telerehabilitation can be used in many cases and provide results on par with face-to-face treatment. In fact, self-administered treatment was found to be effective even in the case of postal treatment where the participants received instruction through postal systems. Second, the pelvic floor area is relatively well-suited for self-treatment. Most, if not all, of the exercises and procedures, can be safely conducted by the patients themselves. The patients can even use pelvic wands and dilators for harder-to-reach inner release points. Therefore, training the patient and supervising and guiding self-administered procedures should be sufficiently effective to reduce pelvic pain and reach patient satisfaction in most cases. The aim of the study will show the efficacy of Telerehabilitation-Based Physical Therapy (TBPT) on pain intensity and treatment satisfaction in patients with chronic pelvic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain, Telerehabilitation, Pelvic Floor; Relaxation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation group
Arm Type
Experimental
Arm Description
Multimodal self-treatment-based telerehabilitation will be implemented with a video conference method. For telerehabilitation, at each session, manual therapy techniques, (i.e., stretching, myofascial release, and tissue desensitization), sex education, and pelvic floor muscle relaxation massages with a pelvic wand (i.e., relaxation, stretching) using small intra-vaginal wand were used. Women were also asked to perform home exercises resembling those performed under supervision five times per week as well as auto-insertion exercises with a pelvic wand in addition to desensitization techniques three times per week. Sessions consist of 60 minutes. Telerehabilitation will take place 2 days a week for 12 weeks.
Arm Title
Education group
Arm Type
No Intervention
Arm Description
60 minutes of video recording training will be given about pelvic pain relaxation exercises.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation Treatment
Intervention Description
Telerehabilitation includes self-massages for pelvic floor muscle, sex education, breathing, myofascial releasing with wand, and pelvic floor relaxing exercises.
Primary Outcome Measure Information:
Title
Pelvic Pain Impact Questionnaire
Description
The Pelvic Pain Impact Questionnaire is a questionnaire composed of eight (8) questions. The patient is asked to grade how pelvic pain has affected various activities on a 5-point Likert scale. The total score is obtained by adding the scores given for each item, a high score is directly proportional to the severity of pain.
Time Frame
1-3 monts
Title
VAS
Description
The VAS is frequently used in cases where rapid measurement of pain intensity is required in clinical and laboratory conditions. It consists of drawing a line from zero (0) to ten (10) and ask the patient to mark the pain intensity on the line where zero (0) means "I have no pain" and ten (10) means "the most severe pain possible".
Time Frame
1-3 months
Title
The Female Sexual Function Index
Description
The Female Sexual Function Index is a brief multidimensional scale for assessing sexual function in women. The scale has received initial psychometric evaluation, including studies of reliability, convergent validity, and discriminant validity
Time Frame
1-3 months
Title
The Female Sexual Distress Scale-Revised
Description
The Female Sexual Distress Scale-Revised was used to assess sexual distress, with higher scores relating to more sexual distress
Time Frame
1-3 months
Title
Vaginal Penetration Cognition Questionnaire
Description
To assess cognition regarding vaginal penetration in women with vaginismus or dyspareunia
Time Frame
1-3 months
Secondary Outcome Measure Information:
Title
The Patient Global Impression of Change
Description
The Patient Global Impression of Change allowed the participants to self-report their perceived improvement (categories ranging from very much improved to very much worse). The PGI-I requires the patient to grade on a seven (7) point likert scale how the condition has evolved compared to how it was prior to the treatment. All questionnaires have validity and reliability in Turkish language .
Time Frame
1-3 motnhs

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: experienced pelvic pain (dyspareunia) for over six (6) months prior to the study to be able to use the internet and their willingness to participate. no pelvic floor surgeries no C-section and birth history to have a diagnoses by dyspareunia Exclusion Criteria: to have endometriosis to have a pelvic health physiotherapy history pelvic organ prolapse, or a previous pelvic organ surgery. the use of analgesics in the previous three (3) months, to have a pregnancy, to have an active vaginal or urinary tract infection, or suffering from other comorbidities that affect the lower urinary tract such as diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alime Buyuk, PhD
Phone
+905543239836
Email
alimebuyuk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Selen Dogan, Assos. Prof.
Email
selendogan@akdeniz.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alime Buyuk
Organizational Affiliation
Akdeniz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alime Buyuk
City
Antalya
State/Province
Select State / Province...a
ZIP/Postal Code
07070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alime Buyuk
Phone
05543239836
Email
alimebuyuk@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32631813
Citation
Padoa A, McLean L, Morin M, Vandyken C. The Overactive Pelvic Floor (OPF) and Sexual Dysfunction. Part 2: Evaluation and Treatment of Sexual Dysfunction in OPF Patients. Sex Med Rev. 2021 Jan;9(1):76-92. doi: 10.1016/j.sxmr.2020.04.002. Epub 2020 Jul 4.
Results Reference
background
PubMed Identifier
32818475
Citation
Morin M, Dumoulin C, Bergeron S, Mayrand MH, Khalife S, Waddell G, Dubois MF; PVD Study Group. Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a multicenter, randomized trial. Am J Obstet Gynecol. 2021 Feb;224(2):189.e1-189.e12. doi: 10.1016/j.ajog.2020.08.038. Epub 2020 Aug 18.
Results Reference
background
PubMed Identifier
35077479
Citation
Cyr MP, Dostie R, Camden C, Dumoulin C, Bessette P, Pina A, Gotlieb WH, Lapointe-Milot K, Mayrand MH, Morin M. Improvements following multimodal pelvic floor physical therapy in gynecological cancer survivors suffering from pain during sexual intercourse: Results from a one-year follow-up mixed-method study. PLoS One. 2022 Jan 25;17(1):e0262844. doi: 10.1371/journal.pone.0262844. eCollection 2022.
Results Reference
background
PubMed Identifier
33010968
Citation
Cyr MP, Dumoulin C, Bessette P, Pina A, Gotlieb WH, Lapointe-Milot K, Mayrand MH, Morin M. Feasibility, acceptability and effects of multimodal pelvic floor physical therapy for gynecological cancer survivors suffering from painful sexual intercourse: A multicenter prospective interventional study. Gynecol Oncol. 2020 Dec;159(3):778-784. doi: 10.1016/j.ygyno.2020.09.001. Epub 2020 Oct 1.
Results Reference
background

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Telerehabilitation in Chronic Pelvic Pain

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