Clinical trial NCT06168643: Effects of Core Stability Exercise With Pregnancy Support Belt in Pubic Symphysis Dysfunction.
Official title: Effects of Core Stability Exercises With And Without Pregnancy Support Belt On Pain, Function And Disability In Symphysis Pubis Dysfunction During Pregnancy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Symphysis Pubis Dysfunction
Keywords: Pain
pregnancy
Exercise
Symphysis pubis dysfunction
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 24
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Roland-Morris Questionnaire (modified)
timeFrame: 6th week
measure: Numerical pain rating scale
timeFrame: 6th week
measure: Pain Specific Functional Scale
timeFrame: 6th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International university, Lahore
state: Punjab
Study officials:
References:
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.
citation: 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.
citation: MacLennan 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.