Telerehabilitation in Chronic Pelvic Pain

NCT05698355 | Completed

• 1 other identifier: Akdeniz
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain; Telerehabilitation; Pelvic Floor; Relaxation

Outcome Measures

Primary Outcomes (5)

• 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.

  1-3 monts

• 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".

  1-3 months

• 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

  1-3 months

• 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

  1-3 months

• Vaginal Penetration Cognition Questionnaire

  To assess cognition regarding vaginal penetration in women with vaginismus or dyspareunia

  1-3 months

Secondary Outcomes (1)

• The Patient Global Impression of Change

  1-3 motnhs

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL

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.

Other: Telerehabilitation Treatment

Education group

NO INTERVENTION

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

Interventions

Telerehabilitation Treatment OTHER

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

Telerehabilitation group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Alime Buyuk

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

Location

Related Publications (4)

• 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.

  PMID: 32631813 BACKGROUND

• 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.

  PMID: 32818475 BACKGROUND

• 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.

  PMID: 35077479 BACKGROUND

• 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.

  PMID: 33010968 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alime Buyuk

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized control trial

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: January 16, 2023
• Primary Completion: January 16, 2023
• Study Completion: September 10, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)