Chronic Pelvic Pain SyndromeNCT05875545
Effects of Breathing Exercises in Women With Chronic Pelvic Pain
A study testing Breathing Exercises and Pelvic Floor Exercises in people with Chronic Pelvic Pain Syndrome and Pelvic Floor; Relaxation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chronic Pelvic Pain Syndrome, Pelvic Floor; Relaxation, Breathing Exercises
- What is being tested?
- Breathing Exercises and Pelvic Floor Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Clinical Effects of Breathing Exercises Combined With Pelvic Floor Exercises in Women With Chronic Pelvic Pain
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.
- Being tested
- Breathing Exercises, Pelvic Floor Exercises
- Keywords
- Women with Chronic Pelvic Pain, Breathing Exercises, Pelvic Floor Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing ExercisesOther
Diaphragmatic breathing exercises with a physiotherapist for 8 weeks, two days a week
Pelvic Floor ExercisesOther
Pelvic floor exercises with a physiotherapist for 8 weeks, two days a week
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise Group | Active comparator | Combined breathing and pelvic floor exercises Receives: Other: Breathing Exercises; Other: Pelvic Floor Exercises |
| Control Group | Active comparator | Pelvic floor exercises Receives: Other: Pelvic Floor Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: at the baseline and end of the 8 weeks (16 sessions)
Secondary outcomes (5)
Global Pelvic Floor Disorder Questionnaire
Global pelvic floor disorders will be evaluated at baseline and after 8 weeks
Measured: at the baseline and end of the 8 weeks
Corbin Postural Rating Scale
Measuring of posture changes
Measured: at the baseline and end of the 8 weeks
Pelvic Pain Impact Questionnaire
Clinical evaluation of pelvic pain effect
Measured: at the baseline and end of the 8 weeks
Short Form-36
Evaluation of quality of life
Measured: at the baseline and end of the 8 weeks
Depression, Anxiety and Stress Scale
Evaluation of moods (depression, anxiety and stress)
Measured: at the baseline and end of the 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Jun 2023
- Primary completion1 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Pelvic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875545
- Sponsor's protocol ID
- 109 (19.10.2022)
- Status last verified
- Apr 2023
- First submitted
- 2 May 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 19733958Lamvu 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 17097572Lamvu 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 30566976Bradley 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 28676366Klotz 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Clinical Effects of Breathing Exercises Combined With Pelvic Floor Exercises in Women With Chronic Pelvic Pain
- ClinicalTrials.gov ID
- NCT05875545
- Acronym / sponsor ID
- 109 (19.10.2022)
- Keywords
- Women with Chronic Pelvic Pain, Breathing Exercises, Pelvic Floor Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise Group | Active comparator | Other: Breathing Exercises, Other: Pelvic Floor ExercisesCombined breathing and pelvic floor exercises |
| Control Group | Active comparator | Other: Pelvic Floor ExercisesPelvic floor exercises |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing ExercisesDiaphragmatic breathing exercises with a physiotherapist for 8 weeks, two days a week | Other | Breathing Exercise Group |
| Pelvic Floor ExercisesPelvic floor exercises with a physiotherapist for 8 weeks, two days a week | Other | Breathing Exercise Group, Control Group |
Primary outcome
Change from Baseline Pelvic Floor Muscle Activity (PFMA) at 8 weeks
Time frame: 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.
Change from Baseline Visual Analogue Scale (VAS) at 8 weeks
Time frame: at the baseline and end of the 8 weeks (16 sessions)
Pain severity will be evaluated with the VAS.
Change from Baseline McGill Pain Scale- Short Form at 8 weeks
Time frame: 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.
5 secondary outcomes
Global Pelvic Floor Disorder Questionnaire
Time frame: at the baseline and end of the 8 weeks
Corbin Postural Rating Scale
Time frame: at the baseline and end of the 8 weeks
Pelvic Pain Impact Questionnaire
Time frame: at the baseline and end of the 8 weeks
Short Form-36
Time frame: at the baseline and end of the 8 weeks
Depression, Anxiety and Stress Scale
Time frame: at the baseline and end of the 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Results publication: PubMed 19733958Fall 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.
- Results publication: PubMed 17097572Lamvu 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.
- Results publication: PubMed 30566976Lamvu 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.
- Results publication: PubMed 28676366Bradley 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.
- Results publication: PubMed 29589778Klotz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercises and Pelvic Floor Exercises in people with Chronic Pelvic Pain Syndrome and Pelvic Floor; Relaxation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pelvic Floor Muscle Activity (PFMA) at 8 weeks (time frame: at the baseline and end of the 8 weeks (16 sessions)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05875545, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.