Effects of Core Stability Exercise With Pregnancy Support Belt in Pubic Symphysis Dysfunction.

Symphysis Pubis Dysfunction Clinical Trial

Official title:

Effects of Core Stability Exercises With And Without Pregnancy Support Belt On Pain, Function And Disability In Symphysis Pubis Dysfunction During Pregnancy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168643
• Other study ID #: Ayesha Sarwar
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: December 2023
• Source: Riphah International University
• Contact: Imran Amjad, Post Doc
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: January 15, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pelvic Girdle Pain
• Symphysis Pubis Dysfunction

Intervention

Other:
• Core stability
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 belt
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.

Locations

Country	Name	City	State
Pakistan	Riphah International university, Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

Jain S, Eedarapalli P, Jamjute P, Sawdy R. Symphysis pubis dysfunction: a practical approach to management. The Obstetrician & Gynaecologist. 2006;8(3):153-8.

Maclennan AH, Maclennan SC. Symptom-giving pelvic girdle relaxation of pregnancy, postnatal pelvic joint syndrome and developmental dysplasia of the hip. Acta Obstetricia et Gynecologica Scandinavica. 1997;76(8):760-4.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6th week
Primary	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	6th week
Primary	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	6th Week