Clinical trial NCT04687787: Core Stabilization Versus Routine Routine Exercises in Pelvic Girdle Pain.
Official title: Comparison of Core Stabilization Exercises and Routine Exercise Therapy on Pregnancy Induced Pelvic Girdle Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Girdle Pain
Keywords: Core Stability Exercises
Pelvic Girdle Pain
Pregnancy
Physical therapy management
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups which will receive physical therapy interventions. one will be experimental and other will be control group.
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric pain rating scale (NPRS)
timeFrame: Baseline
measure: Numeric pain rating scale (NPRS)
timeFrame: Post 4 week
measure: Pelvic Girdle Pain Questionnaire (PGPQ)
timeFrame: Baseline
measure: Pelvic Girdle Pain Questionnaire (PGPQ)
timeFrame: Post 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Alam Family Hospital
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Izzat Ali Shah Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Huma Riaz
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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).
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.
citation: 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.