Effects of Core Stability Exercise With Pregnancy Support Belt in Pubic Symphysis Dysfunction.
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2023
CompletedFirst Submitted
Initial submission to the registry
December 5, 2023
CompletedFirst Posted
Study publicly available on registry
December 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2024
CompletedDecember 13, 2023
December 1, 2023
9 months
December 5, 2023
December 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (2)
Core stability
EXPERIMENTALCore stability with pregnancy support belt
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riphah International university, Lahore
Lahore, Punjab Province, Pakistan
Related Publications (3)
Jain S, Eedarapalli P, Jamjute P, Sawdy R. Symphysis pubis dysfunction: a practical approach to management. The Obstetrician & Gynaecologist. 2006;8(3):153-8.
BACKGROUNDDepledge 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.
PMID: 16305268BACKGROUNDMacLennan 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.
PMID: 9348254BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
December 5, 2023
First Posted
December 13, 2023
Study Start
April 5, 2023
Primary Completion
January 1, 2024
Study Completion
January 15, 2024
Last Updated
December 13, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share