ClinicalTrials.gg
CompletedNCT05875545Updated Dec 20, 2024

Effects of Breathing Exercises in Women With Chronic Pelvic Pain

An interventional study of Breathing Exercises and Pelvic Floor Exercises in Chronic Pelvic Pain Syndrome, Pelvic Floor; Relaxation and Breathing Exercises, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

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

Keywords

  • Women with Chronic Pelvic Pain
  • Breathing Exercises
  • Pelvic Floor Exercises
03

In context

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 447 studies on the registry; 138 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Breathing Exercise Group

    Combined breathing and pelvic floor exercises

    Other: Breathing Exercises · Other: Pelvic Floor Exercises

  • Active comparator
    Control Group

    Pelvic floor exercises

    Other: Pelvic Floor Exercises

Interventions

  • OtherBreathing Exercises

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

  • OtherPelvic Floor Exercises

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at the baseline and end of the 8 weeks (16 sessions)

  2. Change from Baseline Visual Analogue Scale (VAS) at 8 weeks

    Pain severity will be evaluated with the VAS.

    Time frame: at the baseline and end of the 8 weeks (16 sessions)

  3. 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.

    Time frame: at the baseline and end of the 8 weeks (16 sessions)

Secondary outcomes

  1. Global Pelvic Floor Disorder Questionnaire

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

    Time frame: at the baseline and end of the 8 weeks

  2. Corbin Postural Rating Scale

    Measuring of posture changes

    Time frame: at the baseline and end of the 8 weeks

  3. Pelvic Pain Impact Questionnaire

    Clinical evaluation of pelvic pain effect

    Time frame: at the baseline and end of the 8 weeks

  4. Short Form-36

    Evaluation of quality of life

    Time frame: at the baseline and end of the 8 weeks

  5. Depression, Anxiety and Stress Scale

    Evaluation of moods (depression, anxiety and stress)

    Time frame: at the baseline and end of the 8 weeks

07

Study locations

1 site
  • Istanbul Saglık Bilimleri University
    Istanbul, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 19733958 ↗
  • 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. PubMed 17097572 ↗
  • 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. PubMed 30566976 ↗
  • 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. PubMed 28676366 ↗
  • 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. PubMed 29589778 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05875545
Responsible party
Sponsor
First posted
May 25, 2023
Start date
Jun 1, 2023
Primary completion
Apr 1, 2024
Completion
Jun 1, 2024
Last update
Dec 20, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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