NCT04687787

Brief Summary

Pregnancy Induced Pelvic Girdle Pain (PGP) is common complaint in pregnant women all over the world and it has a major impact on health and functioning as it decreases quality of life. The onset of PGP is usually seen at 17-19 week of gestation, with a peak of incidence at 24- 36 weeks. The purpose of this study is to compare the effects of stabilization exercises on pregnancy induced pelvic girdle pain and its effects on the activity levels as compare to the physiotherapy exercises that are routinely prescribed

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

December 25, 2020

Last Update Submit

June 14, 2021

Conditions

Keywords

Core Stability ExercisesPelvic Girdle PainPregnancyPhysical therapy management

Outcome Measures

Primary Outcomes (4)

  • Numeric pain rating scale (NPRS)

    Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.

    Baseline

  • Numeric pain rating scale (NPRS)

    Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.

    Post 4 week

  • Pelvic Girdle Pain Questionnaire (PGPQ)

    The Pelvic Girdle Questionnaire (PG Q) is a condition-specific measure for women with pelvic girdle pain (PGP). The questionnaire has 25 items under two sub-scales (20 items for activates and 5 items for symptoms), with percentage scores that range from 0 (no disability) to 100 (great disability).

    Baseline

  • Pelvic Girdle Pain Questionnaire (PGPQ)

    The Pelvic Girdle Questionnaire (PG Q) is a condition-specific measure for women with pelvic girdle pain (PGP). The questionnaire has 25 items under two sub-scales (20 items for activates and 5 items for symptoms), with percentage scores that range from 0 (no disability) to 100 (great disability).

    Post 4 weeks

Study Arms (2)

Group I

EXPERIMENTAL

This group will receive Core Stability Exercises with Application of TENS

Other: Core Stabilization exercises

Group II

ACTIVE COMPARATOR

This group will receive Routinely prescribed Exercises with application of TENS

Other: Routinely prescribed exercises

Interventions

. Each session will be given for 40 mins (20 mins for TENS and 20 Mins for exercise) Core Stability Exercises include Kegel Exercises, Modified V-sit, opposite Arm Leg Raise, Seated Side bends poses, Dumbell Side bends and Pelvic Tilt. Participants will perform 1 set of exercise having 10 repetitions with hold of 5 seconds. Session would be performed thrice a week.

Group I

Each session will be given for 40 mins ( 20 mins for TENS and 20 Mins for exercise Routinely prescribed exercises composed of Hamstring stretches, hip flexor stretches, hip extensor stretches, calf stretches, and back extensor stretches. Participants will perform 1 set of exercise having 10 repetitions with hold of 5 seconds. Session would be performed thrice a week.

Group II

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly pregnant females will be recruited in the study
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women having Pelvic Girdle Pain in 2nd trimester or 1st month of third trimester.
  • Age between 20-40 years.
  • Positive FABER test (leg of patient is placed in figure of 4 and apply small amplitude oscillation are applied at end range of motion after stabilizing opposite side of Pelvis.
  • Positive test elicits pain and limited ROM)
  • Positive P4 test (leg of patient is flexed at 90 degrees in supine position. Sacrum is stabilized by one hand and axial pressure is applied along the femur by other hand.
  • Positive test elicits pain in SI joint).

You may not qualify if:

  • History of Pelvic Fractures and Surgery
  • History of metabolic diseases.
  • Radiculopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alam Family Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Izzat Ali Shah Hospital

Rawalpindi, Punjab Province, 44000, Pakistan

Location

Related Publications (5)

  • Almousa S, Lamprianidou E, Kitsoulis G. The effectiveness of stabilising exercises in pelvic girdle pain during pregnancy and after delivery: A systematic review. Physiother Res Int. 2018 Jan;23(1). doi: 10.1002/pri.1699. Epub 2017 Nov 8.

    PMID: 29115735BACKGROUND
  • Walters C, West S, A Nippita T. Pelvic girdle pain in pregnancy. Aust J Gen Pract. 2018 Jul;47(7):439-443. doi: 10.31128/AJGP-01-18-4467.

    PMID: 30114872BACKGROUND
  • Timothy J. Piper EJ, Mike Haiduke, Mike Waller, and Cathy McMillan. Core Training Exercise Selection During Pregnancy. Strength and Condtioning Journal. 2012;34(1).

    BACKGROUND
  • Saleh MSM, Botla AMM, Elbehary NAM. Effect of core stability exercises on postpartum lumbopelvic pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2019;32(2):205-213. doi: 10.3233/BMR-181259.

    PMID: 30282349BACKGROUND
  • Akhtar MW, Karimi H, Gilani SA. Effectiveness of core stabilization exercises and routine exercise therapy in management of pain in chronic non-specific low back pain: A randomized controlled clinical trial. Pak J Med Sci. 2017 Jul-Aug;33(4):1002-1006. doi: 10.12669/pjms.334.12664.

    PMID: 29067082BACKGROUND

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Officials

  • Huma Riaz

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be kept blind of the treatment provided.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There will be two groups which will receive physical therapy interventions. one will be experimental and other will be control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2020

First Posted

December 29, 2020

Study Start

January 1, 2021

Primary Completion

May 15, 2021

Study Completion

May 30, 2021

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations