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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04687787
Other study ID # Rec/00837 Zahra Ejaz
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date May 30, 2021

Study information

Verified date June 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

the study is Randomized Controlled trial which will be conducted in the Outpatient Physical therapy Department. Patient with suspected PGP will be referred by midwives, physicians or directly contact to Physiotherapist. Sample size of 30 individual was calculated by using open Epi tool with 95% confidence Interval (CI) and 80% Power. Inclusion criteria for patients is 13-28 gestational weeks determined by special test include P4 Test (Posterior Pelvic Pain Provocation) and FABER test (Flexion Abduction and External Rotation). Individuals would be randomly allocated into two groups by sealed envelope method. Assessment will be done at base line and 4th week by using NPRS and PGP Questionnaire. Data will be analyzed by using SPSS version 21.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 30, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - History of Pelvic Fractures and Surgery - History of metabolic diseases. - Radiculopathy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Core Stabilization exercises
. 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.
Routinely prescribed exercises
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.

Locations

Country Name City State
Pakistan Alam Family Hospital Rawalpindi Punjab
Pakistan Izzat Ali Shah Hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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