Symphysis Pubis DysfunctionNCT06168643
Effects of Core Stability Exercise With Pregnancy Support Belt in Pubic Symphysis Dysfunction.
A study testing Core stability and Core stability with pregnancy support belt in people with Symphysis Pubis Dysfunction, run by Riphah International University at 1 site in Pakistan.
Trial summary
Symphysis pubic dysfunction is a well-known clinical problem encountered by many females during pregnancy, yet it has not received much attention in the research literature. As pubic symphysis dysfunction at times presents with severe pain while performing day to day activities and also affects significantly on… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Symphysis Pubis Dysfunction
- What is being tested?
- Core stability and Core stability with pregnancy support belt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Apr 2023to 15 Jan 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 25-35 years females Have pain in the region of pubic symphysis, with or without radiation to the groin.
- Have pain during stair climbing, turning over in bed, standing on one leg. Have tenderness on palpation of symphysis pubis. Have positive active straight leg raise (ASLR) test result
Who cannot join
- Medical conditions preventing use of pregnancy support belts. Pregnant females having SPD but with absolute contraindications to exercise. Posterior (lumber spine or sacroiliac joint) pain that was considered worse than the symphysis pubis pain
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International university, Lahore
Lahore, Punjab Province
Adeela Arif, Mphil, 03320845723, adeela.arif@riphah.edu.pk
About this study
Official title: Effects of Core Stability Exercises With And Without Pregnancy Support Belt On Pain, Function And Disability In Symphysis Pubis Dysfunction During Pregnancy.
Symphysis pubic dysfunction is a well-known clinical problem encountered by many females during pregnancy, yet it has not received much attention in the research literature. As pubic symphysis dysfunction at times presents with severe pain while performing day to day activities and also affects significantly on quality of life in antenatal period, but its effective management remains difficult to determine as no standardized treatment protocols are available. This study may add to the growing body of knowledge in the management of SPD, that if the core stability exercise alone or with the pregnancy support belts yield comparable outcomes and if one technique is superior to the other, which should be the alternative choice of therapy.
Read the detailed description
The study will be a randomized clinical trial and will be conducted in Women Care Clinic, Bahawalpur. This study will be completed in time duration of 10 months after the approval of synopsis. Non-probability convenience sampling technique will be used and participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive core stability exercises and group B will receive core stability exercises along with pregnancy support belt. The data will be assessed at the baseline and after 6th week of treatment. After data collection, the data will be analyzed by using SPSS version 25.
- Conditions
- Symphysis Pubis Dysfunction
- Being tested
- Core stability, Core stability with pregnancy support belt
- Keywords
- Pain, pregnancy, Exercise, Symphysis pubis dysfunction
- Medical subject headings
- Pelvic Girdle Pain, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilityOther
Physical therapy interventions will include core stability exercises which will be demonstrated and will be checked if they are being performed correctly. The exercises guided shall be performed 3 times daily and logbook will be provided to keep the record of exercise program.
Core stability with pregnancy support beltOther
Participants will receive same information and exercises as those in Group A. they will also receive pregnancy support belt. The logbook will be provided to keep the record of hours the belt has been worn along with exercise record.
| Study group | Role | What they receive |
|---|---|---|
| Core stability | Experimental | Not described Receives: Other: Core stability |
| Core stability with pregnancy support belt | Experimental | Not described Receives: Other: Core stability with pregnancy support belt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland-Morris Questionnaire (modified)
Roland-Morris Disability Questionnaire (RMDQ) is designed to assess self-rated physical disability caused by low back pain. This scale is used on subjects of age more than 12 years. Each question is worth one point so score can range from 0 (no disability) to 24 (severe disability).
Measured: 6th week
Numerical pain rating scale
The Numerical pain rating scale is the most commonly used pain scale in the health care. This scale is used on subjects of age more than 9. By using this scale ask the participant to rate their pain orally by giving the numbers from 0-10
Measured: 6th week
Pain Specific Functional Scale
The PSFS is a self-reported valid, reliable, and responsive outcome measure for patients with musculoskeletal problems. Patients are asked to identify up to five important activities they are unable to perform and rate (on an 11-point scale) the current level of difficulty associated with each activity."0" represents "unable to perform" and "10" represents "able to perform at prior level
Measured: 6th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start5 Apr 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Symphysis Pubis DysfunctionStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeela Arif, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168643
- Sponsor's protocol ID
- Ayesha Sarwar
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jain S, Eedarapalli P, Jamjute P, Sawdy R. Symphysis pubis dysfunction: a practical approach to management. The Obstetrician & Gynaecologist. 2006;8(3):153-8.
Depledge J, McNair PJ, Keal-Smith C, Williams M. Management of symphysis pubis dysfunction during pregnancy using exercise and pelvic support belts. Phys Ther. 2005 Dec;85(12):1290-300.
PubMed 16305268MacLennan AH, MacLennan SC. Symptom-giving pelvic girdle relaxation of pregnancy, postnatal pelvic joint syndrome and developmental dysplasia of the hip. The Norwegian Association for Women with Pelvic Girdle Relaxation (Landforeningen for Kvinner Med Bekkenlosningsplager). Acta Obstet Gynecol Scand. 1997 Sep;76(8):760-4. doi: 10.3109/00016349709024343.
PubMed 9348254
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Stability Exercises With And Without Pregnancy Support Belt On Pain, Function And Disability In Symphysis Pubis Dysfunction During Pregnancy.
- ClinicalTrials.gov ID
- NCT06168643
- Acronym / sponsor ID
- Ayesha Sarwar
- Conditions
- Symphysis Pubis Dysfunction
- Keywords
- Pain, pregnancy, Exercise, Symphysis pubis dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 13 Dec 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.
Symphysis pubic dysfunction is a well-known clinical problem encountered by many females during pregnancy, yet it has not received much attention in the research literature. As pubic symphysis dysfunction at times presents with severe pain while performing day to day activities and also affects significantly on quality of life in antenatal period, but its effective management remains difficult to determine as no standardized treatment protocols are available. This study may add to the growing body of knowledge in the management of SPD, that if the core stability exercise alone or with the pregnancy support belts yield comparable outcomes and if one technique is superior to the other, which should be the alternative choice of therapy.
Detailed description
The study will be a randomized clinical trial and will be conducted in Women Care Clinic, Bahawalpur. This study will be completed in time duration of 10 months after the approval of synopsis. Non-probability convenience sampling technique will be used and participants will be recruited in study after randomization. The subjects will be divided into two groups. Group A will receive core stability exercises and group B will receive core stability exercises along with pregnancy support belt. The data will be assessed at the baseline and after 6th week of treatment. After data collection, the data will be analyzed by using SPSS version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stability | Experimental | Other: Core stability |
| Core stability with pregnancy support belt | Experimental | Other: Core stability with pregnancy support belt |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 25-35 years females Have pain in the region of pubic symphysis, with or without radiation to the groin.
- Have pain during stair climbing, turning over in bed, standing on one leg. Have tenderness on palpation of symphysis pubis. Have positive active straight leg raise (ASLR) test result
Key exclusion criteria (1 listed)
- Medical conditions preventing use of pregnancy support belts. Pregnant females having SPD but with absolute contraindications to exercise. Posterior (lumber spine or sacroiliac joint) pain that was considered worse than the symphysis pubis pain
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 |
|---|---|---|
| Core stabilityPhysical therapy interventions will include core stability exercises which will be demonstrated and will be checked if they are being performed correctly. The exercises guided shall be performed 3 times daily and logbook will be provided to keep the record of exercise program. | Other | Core stability |
| Core stability with pregnancy support beltParticipants will receive same information and exercises as those in Group A. they will also receive pregnancy support belt. The logbook will be provided to keep the record of hours the belt has been worn along with exercise record. | Other | Core stability with pregnancy support belt |
Primary outcome
Roland-Morris Questionnaire (modified)
Time frame: 6th week
Roland-Morris Disability Questionnaire (RMDQ) is designed to assess self-rated physical disability caused by low back pain. This scale is used on subjects of age more than 12 years. Each question is worth one point so score can range from 0 (no disability) to 24 (severe disability).
Numerical pain rating scale
Time frame: 6th week
The Numerical pain rating scale is the most commonly used pain scale in the health care. This scale is used on subjects of age more than 9. By using this scale ask the participant to rate their pain orally by giving the numbers from 0-10
Pain Specific Functional Scale
Time frame: 6th Week
The PSFS is a self-reported valid, reliable, and responsive outcome measure for patients with musculoskeletal problems. Patients are asked to identify up to five important activities they are unable to perform and rate (on an 11-point scale) the current level of difficulty associated with each activity."0" represents "unable to perform" and "10" represents "able to perform at prior level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- BackgroundJain S, Eedarapalli P, Jamjute P, Sawdy R. Symphysis pubis dysfunction: a practical approach to management. The Obstetrician & Gynaecologist. 2006;8(3):153-8.
- Background: PubMed 16305268Depledge J, McNair PJ, Keal-Smith C, Williams M. Management of symphysis pubis dysfunction during pregnancy using exercise and pelvic support belts. Phys Ther. 2005 Dec;85(12):1290-300.
- Background: PubMed 9348254MacLennan AH, MacLennan SC. Symptom-giving pelvic girdle relaxation of pregnancy, postnatal pelvic joint syndrome and developmental dysplasia of the hip. The Norwegian Association for Women with Pelvic Girdle Relaxation (Landforeningen for Kvinner Med Bekkenlosningsplager). Acta Obstet Gynecol Scand. 1997 Sep;76(8):760-4. doi: 10.3109/00016349709024343.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stability and Core stability with pregnancy support belt in people with Symphysis Pubis Dysfunction, run by Riphah International University at 1 site in Pakistan.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Post Doc (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland-Morris Questionnaire (modified) (time frame: 6th week). 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 NCT06168643, which also lists 3 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 13 Dec 2023.