Clinical trial NCT05875545: Effects of Breathing Exercises in Women With Chronic Pelvic Pain
Official title: Investigation of the Clinical Effects of Breathing Exercises Combined With Pelvic Floor Exercises in Women With Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Pelvic Floor; Relaxation
Breathing Exercises
Women
Keywords: Women with Chronic Pelvic Pain
Breathing Exercises
Pelvic Floor Exercises
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Pelvic Floor Muscle Activity (PFMA) at 8 weeks
timeFrame: at the baseline and end of the 8 weeks (16 sessions)
measure: Change from Baseline Visual Analogue Scale (VAS) at 8 weeks
timeFrame: at the baseline and end of the 8 weeks (16 sessions)
measure: Change from Baseline McGill Pain Scale- Short Form at 8 weeks
timeFrame: at the baseline and end of the 8 weeks (16 sessions)
Secondary outcomes:
measure: Global Pelvic Floor Disorder Questionnaire
timeFrame: at the baseline and end of the 8 weeks
measure: Corbin Postural Rating Scale
timeFrame: at the baseline and end of the 8 weeks
measure: Pelvic Pain Impact Questionnaire
timeFrame: at the baseline and end of the 8 weeks
measure: Short Form-36
timeFrame: at the baseline and end of the 8 weeks
measure: Depression, Anxiety and Stress Scale
timeFrame: at the baseline and end of the 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Saglık Bilimleri University
Study officials:
References:
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 31.
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.
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.
citation: 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.
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: 10.1080/09593985.2018.1455251. Epub 2018 Mar 28.