Effects of Breathing Exercises in Women With Chronic Pelvic Pain

NCT05875545 | Completed

• 1 other identifier: 109 (19.10.2022)
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pelvic Pain Syndrome; Pelvic Floor; Relaxation; Breathing Exercises; Women

Keywords

Women with Chronic Pelvic Pain; Breathing Exercises; Pelvic Floor Exercises

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Global Pelvic Floor Disorder Questionnaire

  at the baseline and end of the 8 weeks

• Corbin Postural Rating Scale

  at the baseline and end of the 8 weeks

• Pelvic Pain Impact Questionnaire

  at the baseline and end of the 8 weeks

• Short Form-36

  at the baseline and end of the 8 weeks

• Depression, Anxiety and Stress Scale

  at the baseline and end of the 8 weeks

Study Arms (2)

Breathing Exercise Group

ACTIVE COMPARATOR

Combined breathing and pelvic floor exercises

Other: Breathing Exercises; Other: Pelvic Floor Exercises

Control Group

ACTIVE COMPARATOR

Pelvic floor exercises

Other: Pelvic Floor Exercises

Interventions

Breathing Exercises OTHER

Diaphragmatic breathing exercises with a physiotherapist for 8 weeks, two days a week

Breathing Exercise Group

Pelvic Floor Exercises OTHER

Pelvic floor exercises with a physiotherapist for 8 weeks, two days a week

Breathing Exercise Group; Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women with chronic pelvic pain
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Istanbul Saglık Bilimleri University

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 19733958 RESULT

• 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.

  PMID: 17097572 RESULT

• 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.

  PMID: 30566976 RESULT

• 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.

  PMID: 28676366 RESULT

• 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.

  PMID: 29589778 RESULT

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 25, 2023
• Study Start: June 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 20, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)