Symphysis Pubis DysfunctionPubic PainNCT07919548
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
A study testing educational program and modified lumbopelvic belt in people with Symphysis Pubis Dysfunction and Pregnancy, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of pelvic floor muscle training and a modified lumbopelvic belt on pain, kinesiophobia, and functional status in pregnant women with symphysis pubis pain.Although the power analysis yielded a relatively small minimum sample size, the target sample size was increased… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Symphysis Pubis Dysfunction, Pregnancy, Pregnancy Complication
- What is being tested?
- educational program and modified lumbopelvic belt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants must:
- Be pregnant and aged 18-40 years.
- Have experienced pubic symphysis pain for at least 2 weeks, with pain more severe than any accompanying posterior pelvic pain.
- Have positive findings on at least two of the following tests: pubic symphysis palpation, modified Trendelenburg test, and active straight leg raise test.
- Provide written informed consent.
Who cannot join
- Participants will be excluded for:
- High-risk pregnancy or a medical contraindication to pelvic support belt use.
- Serious systemic bone disease or a history of serious lumbar or pelvic trauma.
- Current systemic corticosteroid use or active pelvic treatment/orthosis.
- Neurological or cognitive conditions that prevent clinical testing or participation in the exercise program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaraş Sütçü İmam Üniversitesi hastanesi
Kahramanmaraş
Asiya Uzun, Asisstant Proffesor, +90(344) 300-2621, asiyauzun@ksu.edu.tr
About this study
The aim of this study is to investigate the effects of pelvic floor muscle training and a modified lumbopelvic belt on pain, kinesiophobia, and functional status in pregnant women with symphysis pubis pain.Although the power analysis yielded a relatively small minimum sample size, the target sample size was increased to account for potential loss to follow-up and missing data, as may occur in clinical research. Accordingly, the study was planned to include at least 30 pregnant women in the final analysis, and 40 pregnant women will be recruited to allow for potential attrition and withdrawal.
Read the detailed description
The reported prevalence of symphysis pubis dysfunction (SPD) during pregnancy varies across the literature. Data from the general population indicate that SPD affects approximately 3-8% of pregnant women. The incidence of symphysis pubis diastasis, a more severe clinical condition, has been reported across a wide range, from 1 in 300 to 1 in 30,000 pregnancies. However, recent studies report that the prevalence of SPD may exceed 30% among pregnant women with pelvic pain. This variability may be attributed to differences in diagnostic criteria, assessment methods, and sample characteristics.
- Being tested
- educational program, modified lumbopelvic belt
- Keywords
- pregnancy, orthosis, Pelvic Floor Muscle Training, Symphysis Pubis Dysfunction
- Medical subject headings
- Pelvic Girdle Pain, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational programOther
educational program that includes pelvic floor muscle training, diaphragmatic breathing training, modifications to activities of daily living, and protective strategies
modified lumbopelvic beltOther
intervention group and will receive comprehensive physiotherapy education in conjunction with the use of a modified lumbopelvic belt.As part of a structured education program, participants will receive pelvic floor muscle training and diaphragmatic breathing training, as well as guidance on protective and symptom-relieving modifications to activities of daily living and relevant ergonomic and behavioral recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Symphysis Pubis Dysfunction group | Experimental | The first group will be designated as the intervention group and will receive comprehensive physiotherapy education in conjunction with the use of a modified lumbopelvic belt. As part of a structured education program, participants will receive pelvic floor muscle training and diaphragmatic breathing training, as well as guidance on protective and symptom-relieving modifications to activities of daily living and relevant ergonomic and behavioral recommendations. Receives: Other: modified lumbopelvic belt |
| control group | Active comparator | The second group will be designated as the comparison group and will receive an educational program that includes pelvic floor muscle training, diaphragmatic breathing training, modifications to activities of daily living, and protective strategies. No belt will be used in this group. Receives: Other: educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain assesment
Pain intensity will be assessed using a 10-cm visual analog scale (VAS), ranging from 0 to 10. A score of 0 indicates no pain, whereas a score of 10 indicates unbearable pain. The VAS is widely used to assess pain intensity. Pain intensity will be classified as mild (1-4), moderate (5-7), or severe (8-10). Pain in the lower back, back, and pelvic girdle will be assessed separately during activity, at rest, and during sleep at night.
Measured: From enrollment to the end of treatment at 4 weeks
Pain threshold measurement (algometer)
An algometer has long been used to measure soft-tissue pain associated with trigger points (11). An algometer will be used to assess the pressure pain threshold. The device has a blunt, non-sharp probe with a contact surface area of 1 cm². Pressure will be applied perpendicular to the midpoint of the muscle. Before the procedure, participants will be informed about the assessment and instructed to report when they first feel pain as the pressure is gradually increased. Measurements will be taken with the participant in a supine position. The pressure value at which the participant first experiences pain will be recorded as the pain threshold. Three measurements will be taken at 1-minute intervals, and the mean will be calculated (12). The assessment will be performed by applying pressure over the pubic symphysis.
Measured: From enrollment to the end of treatment at 4 weeks
Pelvic Girdle Questionnaire (PGQ)
The PGQ was developed by Stuge et al. (13). It is a condition-specific measure for assessing activity limitations and symptoms in individuals with pelvic girdle pain. It was developed for use in pregnant and postpartum individuals with pelvic girdle pain and can be used in both research and clinical practice. Its Turkish validity and reliability were established by Yelvar et al.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (3)
Oswestry Disability Index (ODI)
The ODI is a questionnaire developed specifically for individuals with low back pain to assess the degree of functional limitation in daily life. Its Turkish version has been tested for validity and reliability. It consists of 10 items addressing pain, personal care, lifting, standing, walking, sitting, traveling, sexual activity, and social life. Each item is scored from 0 to 5, with 0 representing the best level of function and 5 the worst
Measured: From enrollment to the end of treatment at 4 weeks
Tampa Scale for Kinesiophobia (TSK)
The Tampa Scale for Kinesiophobia was used to assess the severity of kinesiophobia in pregnant women. The TSK is a 17-item scale developed to measure fear of movement or reinjury. The original scale was developed by Miller, Kori, and Todd in 1991.The scale uses a four-point Likert response format: strongly disagree = 1, disagree = 2, agree = 3, and strongly agree = 4. To calculate the total score, items 4, 8, 12, and 16 are reverse-scored, and all item scores are summed. The total score ranges from 17 to 68, with higher scores indicating greater kinesiophobia.
Measured: From enrollment to the end of treatment at 4 weeks
World Health Organization Quality of Life Questionnaire-Brief Version (WHOQOL-BREF)
The WHOQOL-BREF is a multidimensional self-report measure developed by the World Health Organization (WHO) to assess quality of life from a biopsychosocial perspective. A shorter version of the original WHOQOL-100, it was published in 1998. The WHOQOL-BREF consists of 26 items covering four domains of quality of life: physical health, psychological health, social relationships, and environment. Each item uses a five-point Likert scale to assess the respondent's perception of their quality of life over the previous two weeks. Scores are calculated separately for each domain and converted to a scale ranging from 0 to 100; higher scores indicate better quality of life. The WHOQOL-BREF enables comprehensive assessment of quality of life in both the general population and specific patient groups. It is widely used as a valid and reliable measure in health, psychology, rehabilitation, and public health research.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Apr 2026
- Primary completion20 Feb 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symphysis Pubis DysfunctionStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asiya Uzun, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919548
- Sponsor's protocol ID
- 2026/047
- Acronym
- Pubic Pain
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
- ClinicalTrials.gov ID
- NCT07919548
- Acronym / sponsor ID
- Pubic Pain / 2026/047
- Keywords
- pregnancy, orthosis, Pelvic Floor Muscle Training, Symphysis Pubis Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 5 Nov 2026 (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 aim of this study is to investigate the effects of pelvic floor muscle training and a modified lumbopelvic belt on pain, kinesiophobia, and functional status in pregnant women with symphysis pubis pain.Although the power analysis yielded a relatively small minimum sample size, the target sample size was increased to account for potential loss to follow-up and missing data, as may occur in clinical research. Accordingly, the study was planned to include at least 30 pregnant women in the final analysis, and 40 pregnant women will be recruited to allow for potential attrition and withdrawal.
Detailed description
The reported prevalence of symphysis pubis dysfunction (SPD) during pregnancy varies across the literature. Data from the general population indicate that SPD affects approximately 3-8% of pregnant women. The incidence of symphysis pubis diastasis, a more severe clinical condition, has been reported across a wide range, from 1 in 300 to 1 in 30,000 pregnancies. However, recent studies report that the prevalence of SPD may exceed 30% among pregnant women with pelvic pain. This variability may be attributed to differences in diagnostic criteria, assessment methods, and sample characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symphysis Pubis Dysfunction group | Experimental | Other: modified lumbopelvic beltThe first group will be designated as the intervention group and will receive comprehensive physiotherapy education in conjunction with the use of a modified lumbopelvic belt. As part of a structured education program, participants will receive pelvic floor muscle training and diaphragmatic breathing training, as well as guidance on protective and symptom-relieving modifications to activities of daily living and relevant ergonomic and behavioral recommendations. |
| control group | Active comparator | Other: educational programThe second group will be designated as the comparison group and will receive an educational program that includes pelvic floor muscle training, diaphragmatic breathing training, modifications to activities of daily living, and protective strategies. No belt will be used in this group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be pregnant and aged 18-40 years.
- Have experienced pubic symphysis pain for at least 2 weeks, with pain more severe than any accompanying posterior pelvic pain.
- Have positive findings on at least two of the following tests: pubic symphysis palpation, modified Trendelenburg test, and active straight leg raise test.
- Provide written informed consent.
Key exclusion criteria (5 listed)
- High-risk pregnancy or a medical contraindication to pelvic support belt use.
- Serious systemic bone disease or a history of serious lumbar or pelvic trauma.
- Current systemic corticosteroid use or active pelvic treatment/orthosis.
- Neurological or cognitive conditions that prevent clinical testing or participation in the exercise program.
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 |
|---|---|---|
| educational programeducational program that includes pelvic floor muscle training, diaphragmatic breathing training, modifications to activities of daily living, and protective strategies | Other | control group |
| modified lumbopelvic beltintervention group and will receive comprehensive physiotherapy education in conjunction with the use of a modified lumbopelvic belt.As part of a structured education program, participants will receive pelvic floor muscle training and diaphragmatic breathing training, as well as guidance on protective and symptom-relieving modifications to activities of daily living and relevant ergonomic and behavioral recommendations. | Other | Symphysis Pubis Dysfunction group |
Primary outcome
VAS pain assesment
Time frame: From enrollment to the end of treatment at 4 weeks
Pain intensity will be assessed using a 10-cm visual analog scale (VAS), ranging from 0 to 10. A score of 0 indicates no pain, whereas a score of 10 indicates unbearable pain. The VAS is widely used to assess pain intensity. Pain intensity will be classified as mild (1-4), moderate (5-7), or severe (8-10). Pain in the lower back, back, and pelvic girdle will be assessed separately during activity, at rest, and during sleep at night.
Pain threshold measurement (algometer)
Time frame: From enrollment to the end of treatment at 4 weeks
An algometer has long been used to measure soft-tissue pain associated with trigger points (11). An algometer will be used to assess the pressure pain threshold. The device has a blunt, non-sharp probe with a contact surface area of 1 cm². Pressure will be applied perpendicular to the midpoint of the muscle. Before the procedure, participants will be informed about the assessment and instructed to report when they first feel pain as the pressure is gradually increased. Measurements will be taken with the participant in a supine position. The pressure value at which the participant first experiences pain will be recorded as the pain threshold. Three measurements will be taken at 1-minute intervals, and the mean will be calculated (12). The assessment will be performed by applying pressure over the pubic symphysis.
Pelvic Girdle Questionnaire (PGQ)
Time frame: From enrollment to the end of treatment at 4 weeks
The PGQ was developed by Stuge et al. (13). It is a condition-specific measure for assessing activity limitations and symptoms in individuals with pelvic girdle pain. It was developed for use in pregnant and postpartum individuals with pelvic girdle pain and can be used in both research and clinical practice. Its Turkish validity and reliability were established by Yelvar et al.
3 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: From enrollment to the end of treatment at 4 weeks
Tampa Scale for Kinesiophobia (TSK)
Time frame: From enrollment to the end of treatment at 4 weeks
World Health Organization Quality of Life Questionnaire-Brief Version (WHOQOL-BREF)
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational program and modified lumbopelvic belt in people with Symphysis Pubis Dysfunction and Pregnancy, run by Kahramanmaras Sutcu Imam University 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asiya Uzun, Asisstant Proffesor (+90(344) 300-2621, asiyauzun@ksu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain assesment (time frame: From enrollment to the end of treatment at 4 weeks). 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?
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 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.