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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05405127
Other study ID # REC/RCR&AHS/22/0518
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 30, 2022
Est. completion date December 2022

Study information

Verified date May 2022
Source Riphah International University
Contact Imran Amjad, Phd
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Lumbopelvic pain refers to self-reported pain in areas of lower region, anterior and posterior pelvic tilt or combination of these. Physical therapy interventions used are breathing exercises with and without core stability exercises. Tool used were Pain Pressure Algometer and Oswestry Disability Index.


Description:

Lumbopelvic pain is self-reported pain. It is common complaint for women after labour, and it is found that 25% of newly delivered women experienced low back and pelvic pain. Different interventions have been used to reduce the lumbopelvic pain in general including exercises, drugs, therapies and massage. An increasingly common approach used within physical therapy management are breathing exercises and core stabilization exercises. This study will used to compare the effects of breathing exercises with and without core stability exercise. Pre-assessment will be done using oswestry disability index as subjective measurement and pain pressure algometer as objective measure.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 35 Years
Eligibility Inclusion Criteria: - Women had parity (2-4) times - Body mass index that did not exceed 30 Kg/m - Lumbopelvic pain at least three months until one year postpartum Exclusion Criteria: - They were pregnant - Had systemic inflammatory diseases - Prolapsed disc - Neuromuscular disorder

Study Design


Intervention

Other:
traditional physical therapy
breathing exercises 10 repetitions, 1set, 3 days/week and targeted abdominal muscles. Total 6 sessions were given each consisting of 30 minutes.
core stability exercises
core stability along with breathing exercise 10 repetitions, 1set, 3 days/week and targeted core muscles. Total 6 sessions were given consisting of 30 minutes.

Locations

Country Name City State
Pakistan Services Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

Bergström C, Persson M, Nergård KA, Mogren I. Prevalence and predictors of persistent pelvic girdle pain 12 years postpartum. BMC Musculoskelet Disord. 2017 Sep 16;18(1):399. doi: 10.1186/s12891-017-1760-5. — View Citation

Gutke A, Lundberg M, Östgaard HC, Öberg B. Impact of postpartum lumbopelvic pain on disability, pain intensity, health-related quality of life, activity level, kinesiophobia, and depressive symptoms. Eur Spine J. 2011 Mar;20(3):440-8. doi: 10.1007/s00586-010-1487-6. Epub 2010 Jul 1. — View Citation

Malmqvist S, Kjaermann I, Andersen K, Økland I, Brønnick K, Larsen JP. Prevalence of low back and pelvic pain during pregnancy in a Norwegian population. J Manipulative Physiol Ther. 2012 May;35(4):272-8. doi: 10.1016/j.jmpt.2012.04.004. — View Citation

O'Sullivan PB, Beales DJ. Diagnosis and classification of pelvic girdle pain disorders--Part 1: a mechanism based approach within a biopsychosocial framework. Man Ther. 2007 May;12(2):86-97. Review. — View Citation

Robinson HS, Vøllestad NK, Veierød MB. Clinical course of pelvic girdle pain postpartum - impact of clinical findings in late pregnancy. Man Ther. 2014 Jun;19(3):190-6. doi: 10.1016/j.math.2014.01.004. Epub 2014 Jan 22. — View Citation

Stuber KJ, Wynd S, Weis CA. Adverse events from spinal manipulation in the pregnant and postpartum periods: a critical review of the literature. Chiropr Man Therap. 2012 Mar 28;20:8. doi: 10.1186/2045-709X-20-8. — View Citation

Vermani E, Mittal R, Weeks A. Pelvic girdle pain and low back pain in pregnancy: a review. Pain Pract. 2010 Jan-Feb;10(1):60-71. doi: 10.1111/j.1533-2500.2009.00327.x. Epub 2010 Oct 26. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Oswestry disability index Changes from base line Oswestry disability index was developed first by Fairbank et al. It was designed to measure the back pain and disability over time. It consists of 10, five parts sections. At the end, score is calculated by dividing the obtained score by total (50) multiplied by 100. As the driving section in all the female patients, total score was considered as 45 instead of 50. 6th week
Secondary Pain Pressure Algometer Changes from base line Pain Pressure Algometer was developed first by Baba et al. The pressure algometer has linear response to force application between 0 and 1,300 kilopascal. 6th week
Secondary ROM Back region (flexion) Changes from the Baseline ROM range of motion of back region flexion was taken. 6th week
Secondary ROM Back region (extension) Changes from the baseline ROM range of motion of back region extension was taken. 6th week
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