NCT05405127

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 31, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 6, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 31, 2022

Last Update Submit

May 31, 2022

Conditions

Keywords

breathing exerciseslow back painpost-partum painlumbopelvic pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pain Pressure Algometer

    6th week

  • ROM Back region (flexion)

    6th week

  • ROM Back region (extension)

    6th week

Study Arms (2)

Traditional physical therapy

ACTIVE COMPARATOR

breathing exercises

Other: traditional physical therapy

Core stability exercise

EXPERIMENTAL

core stability exercise along with breathing exercises and pain pressure algometer is used

Other: core stability exercises

Interventions

breathing exercises 10 repetitions, 1set, 3 days/week and targeted abdominal muscles. Total 6 sessions were given each consisting of 30 minutes.

Traditional physical therapy

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.

Core stability exercise

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • They were pregnant
  • Had systemic inflammatory diseases
  • Prolapsed disc
  • Neuromuscular disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Hospital

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

Related Publications (7)

  • Bergstrom C, Persson M, Nergard 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.

    PMID: 28915804BACKGROUND
  • 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.

    PMID: 22455720BACKGROUND
  • Gutke A, Lundberg M, Ostgaard HC, Oberg 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.

    PMID: 20593205BACKGROUND
  • Robinson HS, Vollestad NK, Veierod 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.

    PMID: 24508067BACKGROUND
  • Malmqvist S, Kjaermann I, Andersen K, Okland I, Bronnick 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.

    PMID: 22632586BACKGROUND
  • 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. doi: 10.1016/j.math.2007.02.001.

    PMID: 17449432BACKGROUND
  • 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.

    PMID: 19863747BACKGROUND

MeSH Terms

Conditions

Respiratory SoundsLow Back PainPain, PostoperativePelvic Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsPostoperative ComplicationsPathologic Processes

Study Officials

  • Hafiza Mehjabeen, MSWHPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 6, 2022

Study Start

May 30, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

June 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations