Telerehabilitation in Chronic Pelvic Pain

NCT ID: NCT05698355

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2024-09-10

Brief Summary

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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

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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.

Conditions

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Pelvic Pain Telerehabilitation Pelvic Floor; Relaxation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telerehabilitation group

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.

Group Type EXPERIMENTAL

Telerehabilitation Treatment

Intervention Type OTHER

Telerehabilitation includes self-massages for pelvic floor muscle, sex education, breathing, myofascial releasing with wand, and pelvic floor relaxing exercises.

Education group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telerehabilitation Treatment

Telerehabilitation includes self-massages for pelvic floor muscle, sex education, breathing, myofascial releasing with wand, and pelvic floor relaxing exercises.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Alime Buyuk

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alime Buyuk

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

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Alime Buyuk

Antalya, Select State / Province...a, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32631813 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32818475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35077479 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33010968 (View on PubMed)

Other Identifiers

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Akdeniz

Identifier Type: -

Identifier Source: org_study_id

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