NCT06168643

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

December 5, 2023

Last Update Submit

December 5, 2023

Conditions

Keywords

PainpregnancyExerciseSymphysis pubis dysfunction

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

EXPERIMENTAL
Other: Core stability

Core stability with pregnancy support belt

EXPERIMENTAL
Other: Core stability with pregnancy support belt

Interventions

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

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.

Core stability with pregnancy support belt

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

RECRUITING

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.

    BACKGROUND
  • 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.

    PMID: 16305268BACKGROUND
  • 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.

    PMID: 9348254BACKGROUND

MeSH Terms

Conditions

Pelvic Girdle PainPainMotor Activity

Interventions

Core Stability

Condition Hierarchy (Ancestors)

Musculoskeletal PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic PainBehavior

Intervention Hierarchy (Ancestors)

Postural BalanceProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Central Study Contacts

Imran Amjad, Post Doc

CONTACT

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

Locations