Effects of Breathing Exercises in Women With Chronic Pelvic Pain

• Sponsor: Saglik Bilimleri Universitesi (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05875545
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pelvic Pain Syndrome; Pelvic Floor; Relaxation; Breathing Exercises; Women	Other: Breathing Exercises; Other: Pelvic Floor Exercises	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Investigation of the Clinical Effects of Breathing Exercises Combined With Pelvic Floor Exercises in Women With Chronic Pelvic Pain
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from Baseline Pelvic Floor Muscle Activity (PFMA) at 8 weeks [at the baseline and end of the 8 weeks (16 sessions)]

   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.

2. Change from Baseline Visual Analogue Scale (VAS) at 8 weeks [at the baseline and end of the 8 weeks (16 sessions)]

   Pain severity will be evaluated with the VAS.

3. Change from Baseline McGill Pain Scale- Short Form at 8 weeks [at the baseline and end of the 8 weeks (16 sessions)]

   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.

Secondary Outcome Measures

1. Global Pelvic Floor Disorder Questionnaire [at the baseline and end of the 8 weeks]

   Global pelvic floor disorders will be evaluated at baseline and after 8 weeks

2. Corbin Postural Rating Scale [at the baseline and end of the 8 weeks]

   Measuring of posture changes

3. Pelvic Pain Impact Questionnaire [at the baseline and end of the 8 weeks]

   Clinical evaluation of pelvic pain effect

4. Short Form-36 [at the baseline and end of the 8 weeks]

   Evaluation of quality of life

5. Depression, Anxiety and Stress Scale [at the baseline and end of the 8 weeks]

   Evaluation of moods (depression, anxiety and stress)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Saglık Bilimleri University	Istanbul		Turkey

Sponsors and Collaborators

• Saglik Bilimleri Universitesi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Saglik Bilimleri Universitesi
• ClinicalTrials.gov Identifier: NCT05875545
• Other Study ID Numbers: 109 (19.10.2022)
• First Posted: May 25, 2023
• Last Update Posted: May 25, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Saglik Bilimleri Universitesi: Women with Chronic Pelvic Pain; Breathing Exercises; Pelvic Floor Exercises
• Additional relevant MeSH terms: Respiratory Aspiration; Pelvic Pain

Study Results

No Results Posted as of May 25, 2023