Effects of Breathing Exercises in Women With Chronic Pelvic Pain

Investigation of the Clinical Effects of Breathing Exercises Combined With Pelvic Floor Exercises in Women With Chronic Pelvic Pain

The primary cause of the complex interaction of chronic pelvic pain originates from the visceral organs in the pelvic cavity, and it has been observed that musculoskeletal dysfunctions (such as increased muscle activity in the pelvic floor muscles) are often accompanied by visceral painful stimuli in the pelvic region as a result of shared innervation and visceral-somatic convergence.

This study aims to investigate the effect of breathing exercises combined with pelvic floor exercises on pain, pelvic floor muscle activity, psychological factors, and quality of life in women with chronic pelvic pain.

Study Overview

• Status: Completed
• Conditions: Chronic Pelvic Pain Syndrome; Breathing Exercises; Women; Pelvic Floor; Relaxation
• Intervention / Treatment: Other: Breathing Exercises; Other: Pelvic Floor Exercises

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İstanbul Sağlık Bilimleri University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be diagnosed with chronic pelvic pain (CPA)
• Having pelvic pain for at least 6 months
• 18-45 years old
• Having high resting activity of the pelvic floor (>2 microvolts based on superficial EMG (sEMG) readings)

Exclusion Criteria:

• Having a history of pelvic cancer and/or surgery
• Receiving radiotherapy and/or chemotherapy
• Having a neurological and/or psychiatric pathology
• Have a urinary tract infection
• Menopause
• Presence of current pregnancy status
• History of miscarriage and ectopic pregnancy
• Presence of prolapse
• Being >30 kg/cm2 according to body mass index (BMI)
• Have received treatment for the pelvic area including manual therapy and electrotherapy in the last 6 months
• Having had botulinum toxin injections in the pelvic region in the last 6 months
• Having a communication problem

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Breathing Exercise Group; Combined breathing and pelvic floor exercises	Other: Breathing Exercises; Diaphragmatic breathing exercises with a physiotherapist for 8 weeks, two days a week; Other: Pelvic Floor Exercises; Pelvic floor exercises with a physiotherapist for 8 weeks, two days a week
Active Comparator: Control Group; Pelvic floor exercises	Other: Pelvic Floor Exercises; Pelvic floor exercises with a physiotherapist for 8 weeks, two days a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Pelvic Floor Muscle Activity (PFMA) at 8 weeks	PFMA measurement will be performed with the sEMG NeuroTrac MyoPlus Pro (Verity Medical Ltd, UK) device integrated with computer software for digital analysis and report generation.	at the baseline and end of the 8 weeks (16 sessions)
Change from Baseline Visual Analogue Scale (VAS) at 8 weeks	Pain severity will be evaluated with the VAS.	at the baseline and end of the 8 weeks (16 sessions)
Change from Baseline McGill Pain Scale- Short Form at 8 weeks	The scale consists of 3 parts. In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. In the second part, there were five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. In the third part, the current pain intensity of the patient was evaluated using a visual comparison scale.	at the baseline and end of the 8 weeks (16 sessions)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Pelvic Floor Disorder Questionnaire	Global pelvic floor disorders will be evaluated at baseline and after 8 weeks	at the baseline and end of the 8 weeks
Corbin Postural Rating Scale	Measuring of posture changes	at the baseline and end of the 8 weeks
Pelvic Pain Impact Questionnaire	Clinical evaluation of pelvic pain effect	at the baseline and end of the 8 weeks
Short Form-36	Evaluation of quality of life	at the baseline and end of the 8 weeks
Depression, Anxiety and Stress Scale	Evaluation of moods (depression, anxiety and stress)	at the baseline and end of the 8 weeks

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Publications and helpful links

General Publications

• Fall M, Baranowski AP, Elneil S, Engeler D, Hughes J, Messelink EJ, Oberpenning F, de C Williams AC; European Association of Urology. EAU guidelines on chronic pelvic pain. Eur Urol. 2010 Jan;57(1):35-48. doi: 10.1016/j.eururo.2009.08.020. Epub 2009 Aug 31.
• Lamvu G, Steege JF. The anatomy and neurophysiology of pelvic pain. J Minim Invasive Gynecol. 2006 Nov-Dec;13(6):516-22. doi: 10.1016/j.jmig.2006.06.021. No abstract available.
• Lamvu G, Carrillo J, Witzeman K, Alappattu M. Musculoskeletal Considerations in Female Patients with Chronic Pelvic Pain. Semin Reprod Med. 2018 Mar;36(2):107-115. doi: 10.1055/s-0038-1676085. Epub 2018 Dec 19.
• Bradley MH, Rawlins A, Brinker CA. Physical Therapy Treatment of Pelvic Pain. Phys Med Rehabil Clin N Am. 2017 Aug;28(3):589-601. doi: 10.1016/j.pmr.2017.03.009. Epub 2017 May 12.
• Klotz SGR MSc, PT, HS, Schon M BSc, PT, Ketels G BA, PT, HE, Lowe B MD, Brunahl CA MD. Physiotherapy management of patients with chronic pelvic pain (CPP): A systematic review. Physiother Theory Pract. 2019 Jun;35(6):516-532. doi: 10.1080/09593985.2018.1455251. Epub 2018 Mar 28.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Breathing Exercises; Pelvic Floor Exercises; Women with Chronic Pelvic Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Pelvic Pain
• Other Study ID Numbers: 109 (19.10.2022)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No