Effects of Breathing Exercises in Women With Chronic Pelvic Pain

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Breathing Exercises
* Other: Pelvic Floor Exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Women with Chronic Pelvic Pain, Breathing Exercises, Pelvic Floor Exercises