Effects of Breathing Exercises in Women With Chronic Pelvic Pain

Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05875545
• Other study ID #: 109 (19.10.2022)
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2023
• Source: Saglik Bilimleri Universitesi
• Contact: Merve Can Kalan, MsC
• Phone: 05388397713
• Email: mervecaann[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: April 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breathing Exercises
• Chronic Pelvic Pain Syndrome
• Pelvic Floor; Relaxation
• Pelvic Pain
• Respiratory Aspiration
• Women

Intervention

Other:
• Breathing Exercises
Diaphragmatic breathing exercises with a physiotherapist for 8 weeks, two days a week
• Pelvic Floor Exercises
Pelvic floor exercises with a physiotherapist for 8 weeks, two days a week

Locations

Country	Name	City	State
Turkey	Istanbul Saglik Bilimleri University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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 3 — View Citation

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: 10.1080/09593985.2018.14 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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
Secondary	Corbin Postural Rating Scale	Measuring of posture changes	at the baseline and end of the 8 weeks
Secondary	Pelvic Pain Impact Questionnaire	Clinical evaluation of pelvic pain effect	at the baseline and end of the 8 weeks
Secondary	Short Form-36	Evaluation of quality of life	at the baseline and end of the 8 weeks
Secondary	Depression, Anxiety and Stress Scale	Evaluation of moods (depression, anxiety and stress)	at the baseline and end of the 8 weeks