Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain

Low Back Pain Clinical Trial

Official title:

Comparison of Generalized Versus Core Stabilization Antenatal Exercises For Lumbopelvic Pain In Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06303258
• Other study ID #: RiphahIU Sharmeen Kanwar
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: Sharmeen Kanwar, MS-WHPT*
• Phone: 0307-8778164
• Email: kanwarsharmeen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Core stability training has gained popularity as a fitness trend and is now being used in rehabilitation programs as well the patient adherence to this intervention has been low due to its complex nature, particularly pregnant females .Limited literature is available to present the effect of core stabilization exercises in comparison to the other handful simplified techniques and exercises This study compares two interventions for this particular condition to identify a feasible and enjoyable therapeutic intervention for the pregnant women who suffer Lumbopelvic Pain.

Description:

This is a randomized control trial to compare the effects of core stabilization versus generalized antenatal exercises for lumbopelvic pain in pregnant women. Females meeting the inclusion and exclusion criteria will be divided into three groups by convenient sampling technique. A sample size of 48 females with 16 females in each group. Group A will be treated by core stability exercises and group B will be treated by generalized antenatal exercises and group C will receive basic antenatal education. Group A and B will have three treatment sessions per week for 4 weeks. Females will be evaluated at baseline and 2nd and 4th week . Females will be screened by Patricks faber test, piriformis /FAIR test, p4/posterior pelvic pain provocation test and assessed by visual analogue scale (VAS) and pregnant women quality of life questionnaire (QOL- GRAV).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• 2nd Trimester of Pregnancy
• Multigravida
• Patients having Lumbopelvic pain
• Working women and housewives

Exclusion Criteria:

• Hx of Metabolic Disease
• Hx of Pelvic Fracture and Surgery
• Radiculopathy
• Participants with absolute contraindications for the exercise

Related Conditions & MeSH terms

• Low Back Pain
• Pelvic Pain

Intervention

Other:
• Core Stabalization Exercises
Low Intensity Warm Up Exercises Core Stabilization Exercises Cool Down Stretching Exercises
• Generalized Antenatal Exercises
Low Intensity WarmUp Exercise Aerobic Training Endurance Training Pelvic Floor Muscle Training Cool Down Stretching Exercises

Locations

Country	Name	City	State
Pakistan	Tehsil Headquarter Hospital Raiwind	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Leonard JH, Paungmali A, Sitilertpisan P, Pirunsan U, Uthaikhup S. Changes in Transversus Abdominis Muscle Thickness after Lumbo-Pelvic Core Stabilization Training among Chronic Low Back Pain Individuals. Clin Ter. 2015;166(5):e312-6. doi: 10.7417/T.2015.1884. — View Citation

Sklempe Kokic I, Ivanisevic M, Uremovic M, Kokic T, Pisot R, Simunic B. Effect of therapeutic exercises on pregnancy-related low back pain and pelvic girdle pain: Secondary analysis of a randomized controlled trial. J Rehabil Med. 2017 Mar 6;49(3):251-257. doi: 10.2340/16501977-2196. — View Citation

Stuge B. Evidence of stabilizing exercises for low back- and pelvic girdle pain - a critical review. Braz J Phys Ther. 2019 Mar-Apr;23(2):181-186. doi: 10.1016/j.bjpt.2018.11.006. Epub 2018 Nov 17. — View Citation

Varela-Esquivias A, Diaz-Martinez L, Avendano-Badillo D. [Efficacy of lumbopelvic stabilization exercises in patients with lumbalgia]. Acta Ortop Mex. 2020 Jan-Feb;34(1):10-15. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients	Changes from Baseline to 2nd week
Primary	Visual Analogue Scale (VAS)	It is a numeric rating scale from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain.it is used to rate the pain intensity in patients	Changes from 2nd week to 4th week
Primary	Pregnant women's quality of life questionnaire (QOL-GRAV)	Nine items make up the scale that allows individuals to describe their individual experiences with pregnancy's quality of life. It had a greater internal consistency than 0.7. A 5-point Likert scale (ranging from not at all [0] to totally [4]) was used to rate each item. The final three questions-7, 8 and 9-are scored in reverse.	Changes from Baseline to 2nd week
Primary	Pregnant women's quality of life questionnaire (QOL-GRAV)	Nine items make up the scale that allows individuals to describe their individual experiences with pregnancy's quality of life. It had a greater internal consistency than 0.7. A 5-point Likert scale (ranging from not at all [0] to totally [4]) was used to rate each item. The final three questions-7, 8 and 9-are scored in reverse.	Changes from 2nd week to 4th week