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Sequential Core Stability Corrective Exercise Approach in Lower Crossed Syndrome (SCSCRLCS)

Primary Purpose

Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Control
Sequential Core Stability Corrective Exercise Approach
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Alignment, Core Stability, Diaphragm, Pelvic floor, Dysfunction

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Age group between 18 to 28 years

    • No current incidence of low back pain or past history of low back dysfunction
    • Kendall double leg lowering test: Abdominal muscle weakness to the extent of not being able to maintain posterior pelvic tilt during a double leg lowering test in supine position.
    • Diagnosed with lower cross syndrome through assessment criteria of Janda muscle testing and assessment

Exclusion Criteria:

  • • Having any history of low back pain, spinal trauma,

    • Joint dysfunction in past 3 months
    • Congenital deformities at hip or lumbar region,
    • Recent fracture to related joints in past 6 months
    • Any family history of cardiopulmonary disease
    • Any disease or urogenital tract
    • Participants having BMI above 30.
    • Recent history of hepatitis or Fatty liver or
    • Any athlete having high physical activity.
    • History of abdominal, hip or lumbar surgeries in past 3 months

Sites / Locations

  • Al-khumeini Trust Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A: Control

B: Sequential Core Stability Corrective Exercise Approach

Arm Description

Corrective Exercises Hip Flexor Stretch 30 seconds hold 3 repetitions on each side Thoracolumbar extensors stretch 30 second holds 3 repetitions Abdominal Curl ups with hands at side 10 repetitions 2 sets Progression: • Abdominal curl up with arms crossed • Abdominal curl ups with hands behind head Pelvic bridging 10 seconds hold 10 repetitions 2 sets

Corrective Exercises Diaphragm Training Program As per standardized pulmonary rehabilitation guidelines,. Participant will be advised to breathe in gently with an improved tidal volume for ten repetitions, then after a short interval of break 15 repetitions will be done again. 30 Repetitions in set of 15, 15 with the interval rest. 2 sets. Pelvic floor Muscle training Participants will be asked to do pelvic floor training with high intensity (close to maximum) contractions with holding each muscle contraction for 6-8 seconds with relaxation of 6 seconds. Total 8 to 12 contractions. Core Stability exercises Beginning Progressing Advanced

Outcomes

Primary Outcome Measures

Photometry for Pelvic Tilt
Angle of Pelvic tilt will be measured Through a Reliable and validated camera.
Photometry for Chest Expansion
Angle of Chest expansion will be measured at Nipple line, Xiphoid level and at waist level, Through a Reliable and validated camera.
Photometry for Cervicothoracic level
Angle of C7-T1 will be measured Through a Reliable and validated camera.
Photometry for Lumber flexion
Angle of Lumber curve will be measured Through a Reliable and validated camera.
Diaphragmatic excursion
To assess the diaphragmatic motion by M-mode US a 2.5-5 megahertz (MHz) phase array will be used.
Levator ani Excursion
To assess the pelvic floor motion by M-mode US a 2.5-5 megahertz (MHz) array will be used.
Diaphragmatic thickness and thickening
diaphragmatic thicknesses and thickening will be assessed by B-mode ultrasonography during various respiratory maneuvers
Levator ani thickness and thickening
Levator ani thicknesses and thickening will be assessed by B-mode ultrasonography during various respiratory maneuvers
Core stability
It will be measured by Pressure biofeedback unit for the transverse abdomens.

Secondary Outcome Measures

Forced Vital Capacity (FVC)
Pulmonary function test through spirometer, It will be measured by digital spirometer.
Forced Expiratory Volume per second FEV1
Pulmonary function test through spirometer, It will be measured by digital spirometer.
Ratio of FEV1/ FVC
Pulmonary function test through spirometer, It will be measured by digital spirometer.

Full Information

First Posted
May 23, 2022
Last Updated
August 17, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05505851
Brief Title
Sequential Core Stability Corrective Exercise Approach in Lower Crossed Syndrome
Acronym
SCSCRLCS
Official Title
Sequential Core Stability Corrective Exercise Approach for Alignment And Muscle Function In Lower Crossed Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (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
The objective of the study will be to determine the effects of Sequential Core Stability Corrective Exercise Approach for Alignment and Muscle Function in Lower Crossed Syndrome.
Detailed Description
Lower Crossed Syndrome is one of common postural disorder which occurs due to the muscular imbalance. It refers to specific altered muscle activation and movement patterns along with some postural deviations. Alterations in muscle activation include overactivity of hip flexors and lower back muscles paired underactivity of abdominals and gluteus muscle. This pattern of imbalance creates dysfunction. Postural correction exercise with inner and outer core muscles are necessary. There are different traditional structural approach, functional approach and biomechanics and are presumed to lead to adjustments in the length and strength of local muscles while ignoring other related malalignments and core stability. The objective of the study will be to determine the effects of Sequential Core Stability Corrective Exercise Approach for Alignment and Muscle Function in Lower Crossed Syndrome. It will be a randomized controlled trial. Sample size will be collected after running the pilot study. The participants will be recruited through convenient sampling technique and then allocated randomly to Groups. Outcome measures will be alignment and muscle function. Pre and post reading and after one month follow-up will be recorded. Data will be analyzed using statistical package for social sciences software version 25. After assessing normality of data by Shapiro-Wilk test, it will be decided either parametric or nonparametric test will be use within a group or between two groups. Keywords: Alignment, Core Stability, Diaphragm, Muscular Imbalance, Muscle thickness Pelvic floor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Alignment, Core Stability, Diaphragm, Pelvic floor, Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Control
Arm Type
Active Comparator
Arm Description
Corrective Exercises Hip Flexor Stretch 30 seconds hold 3 repetitions on each side Thoracolumbar extensors stretch 30 second holds 3 repetitions Abdominal Curl ups with hands at side 10 repetitions 2 sets Progression: • Abdominal curl up with arms crossed • Abdominal curl ups with hands behind head Pelvic bridging 10 seconds hold 10 repetitions 2 sets
Arm Title
B: Sequential Core Stability Corrective Exercise Approach
Arm Type
Experimental
Arm Description
Corrective Exercises Diaphragm Training Program As per standardized pulmonary rehabilitation guidelines,. Participant will be advised to breathe in gently with an improved tidal volume for ten repetitions, then after a short interval of break 15 repetitions will be done again. 30 Repetitions in set of 15, 15 with the interval rest. 2 sets. Pelvic floor Muscle training Participants will be asked to do pelvic floor training with high intensity (close to maximum) contractions with holding each muscle contraction for 6-8 seconds with relaxation of 6 seconds. Total 8 to 12 contractions. Core Stability exercises Beginning Progressing Advanced
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Hip Flexor Stretch 30 seconds hold 3 repetitions on each side Thoracolumbar extensors stretch 30 second holds 3 repetitions Abdominal Curl ups with hands at side 10 repetitions 2 sets Progression: • Abdominal curl up with arms crossed • Abdominal curl ups with hands behind head Pelvic bridging 10 seconds hold 10 repetitions 2 sets
Intervention Type
Other
Intervention Name(s)
Sequential Core Stability Corrective Exercise Approach
Intervention Description
Corrective Exercises Diaphragm Training Program As per standardized pulmonary rehabilitation guidelines,. Participant will be advised to breathe in gently with an improved tidal volume for ten repetitions, then after a short interval of break 15 repetitions will be done again. 30 Repetitions in set of 15, 15 with the interval rest. 2 sets. Pelvic floor Muscle training Participants will be asked to do pelvic floor training with high intensity (close to maximum) contractions with holding each muscle contraction for 6-8 seconds with relaxation of 6 seconds. Total 8 to 12 contractions. Core Stability exercises Beginning Progressing Advanced
Primary Outcome Measure Information:
Title
Photometry for Pelvic Tilt
Description
Angle of Pelvic tilt will be measured Through a Reliable and validated camera.
Time Frame
6th Week
Title
Photometry for Chest Expansion
Description
Angle of Chest expansion will be measured at Nipple line, Xiphoid level and at waist level, Through a Reliable and validated camera.
Time Frame
6th Week
Title
Photometry for Cervicothoracic level
Description
Angle of C7-T1 will be measured Through a Reliable and validated camera.
Time Frame
6th Week
Title
Photometry for Lumber flexion
Description
Angle of Lumber curve will be measured Through a Reliable and validated camera.
Time Frame
6th Week
Title
Diaphragmatic excursion
Description
To assess the diaphragmatic motion by M-mode US a 2.5-5 megahertz (MHz) phase array will be used.
Time Frame
6th Week
Title
Levator ani Excursion
Description
To assess the pelvic floor motion by M-mode US a 2.5-5 megahertz (MHz) array will be used.
Time Frame
6th Week
Title
Diaphragmatic thickness and thickening
Description
diaphragmatic thicknesses and thickening will be assessed by B-mode ultrasonography during various respiratory maneuvers
Time Frame
6th Week
Title
Levator ani thickness and thickening
Description
Levator ani thicknesses and thickening will be assessed by B-mode ultrasonography during various respiratory maneuvers
Time Frame
6th Week
Title
Core stability
Description
It will be measured by Pressure biofeedback unit for the transverse abdomens.
Time Frame
6th Week
Secondary Outcome Measure Information:
Title
Forced Vital Capacity (FVC)
Description
Pulmonary function test through spirometer, It will be measured by digital spirometer.
Time Frame
6th Week
Title
Forced Expiratory Volume per second FEV1
Description
Pulmonary function test through spirometer, It will be measured by digital spirometer.
Time Frame
6th Week
Title
Ratio of FEV1/ FVC
Description
Pulmonary function test through spirometer, It will be measured by digital spirometer.
Time Frame
6th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Age group between 18 to 28 years No current incidence of low back pain or past history of low back dysfunction Kendall double leg lowering test: Abdominal muscle weakness to the extent of not being able to maintain posterior pelvic tilt during a double leg lowering test in supine position. Diagnosed with lower cross syndrome through assessment criteria of Janda muscle testing and assessment Exclusion Criteria: • Having any history of low back pain, spinal trauma, Joint dysfunction in past 3 months Congenital deformities at hip or lumbar region, Recent fracture to related joints in past 6 months Any family history of cardiopulmonary disease Any disease or urogenital tract Participants having BMI above 30. Recent history of hepatitis or Fatty liver or Any athlete having high physical activity. History of abdominal, hip or lumbar surgeries in past 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Salman Bashir, PhD
Phone
+923334497959
Email
salman.bashir@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Wajeeha Zia, PhD*
Phone
+922186705503
Email
wajeeha.zia@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wajeeha Zia, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wajeeha Zia, PhD*
Organizational Affiliation
Riphah International University , QIE, Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-khumeini Trust Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wajeeha Zia, PhD*
Phone
+923234500788
Email
wajeeha.zia@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No

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Sequential Core Stability Corrective Exercise Approach in Lower Crossed Syndrome

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