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Breathing and Core Stability Exercise Effects on Lumbopelvic Pain

Primary Purpose

Breathing Sound, Low Back Pain, Post-operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
traditional physical therapy
core stability exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breathing Sound focused on measuring breathing exercises, low back pain, post-partum pain, lumbopelvic pain

Eligibility Criteria

25 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Services HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional physical therapy

Core stability exercise

Arm Description

breathing exercises

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
ROM Back region (flexion)
Changes from the Baseline ROM range of motion of back region flexion was taken.
ROM Back region (extension)
Changes from the baseline ROM range of motion of back region extension was taken.

Full Information

First Posted
May 31, 2022
Last Updated
May 31, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05405127
Brief Title
Breathing and Core Stability Exercise Effects on Lumbopelvic Pain
Official Title
Effects of Breathing Exercises With and Without Core Stability Exercises on Pain Pressure Threshold and Disability in Postpartum Females With Lumbopelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing Sound, Low Back Pain, Post-operative Pain, Pelvic Pain
Keywords
breathing exercises, low back pain, post-partum pain, lumbopelvic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional physical therapy
Arm Type
Active Comparator
Arm Description
breathing exercises
Arm Title
Core stability exercise
Arm Type
Experimental
Arm Description
core stability exercise along with breathing exercises and pain pressure algometer is used
Intervention Type
Other
Intervention Name(s)
traditional physical therapy
Intervention Description
breathing exercises 10 repetitions, 1set, 3 days/week and targeted abdominal muscles. Total 6 sessions were given each consisting of 30 minutes.
Intervention Type
Other
Intervention Name(s)
core stability exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oswestry disability index
Description
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.
Time Frame
6th week
Secondary Outcome Measure Information:
Title
Pain Pressure Algometer
Description
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.
Time Frame
6th week
Title
ROM Back region (flexion)
Description
Changes from the Baseline ROM range of motion of back region flexion was taken.
Time Frame
6th week
Title
ROM Back region (extension)
Description
Changes from the baseline ROM range of motion of back region extension was taken.
Time Frame
6th week

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, MSWHPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Services Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54660
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafiza Mehjabeen, MSWHPT
Phone
03026577666
Email
hafiza.mehjabeen@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Hafsa Khalid, MS(WHPT)

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28915804
Citation
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.
Results Reference
background
PubMed Identifier
22455720
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.
Results Reference
background
PubMed Identifier
20593205
Citation
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.
Results Reference
background
PubMed Identifier
24508067
Citation
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.
Results Reference
background
PubMed Identifier
22632586
Citation
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.
Results Reference
background
PubMed Identifier
17449432
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. doi: 10.1016/j.math.2007.02.001.
Results Reference
background
PubMed Identifier
19863747
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.
Results Reference
background

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Breathing and Core Stability Exercise Effects on Lumbopelvic Pain

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