Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles

Clinical Assessment and Thickness Changes of the Oblique and Multifidus Muscles Using a Novel Screening Tool and Exercise Program: A Randomized Controlled Trial

This study evaluates the effect of a rotation based exercise program on core muscle thickness. Additionally, a second aim is to demonstrate the ability of a clinical assessment tool to identify muscle thickness changes. Half of participants receive the rotation based exercises, while the other half perform a traditional core exercise program. It was hypothesized that the rotation based exercises would result in greater changes in muscle thickness.

Study Overview

• Status: Completed
• Conditions: Abdominal Muscles
• Intervention / Treatment: Other: Rotation Exercises; Other: Control Exercises

Detailed Description

A number of exercise programs and assessment tools have been evaluated for their ability to influence and measure the core muscles. Inefficient stability and asymmetrical muscle activity of the core have been linked to a wide range of lower extremity injuries. Training of the abdominal muscles to obtain symmetrical recruitment for optimal trunk stabilization is a widespread clinical practice, however valid and reliable assessment tools and effective intervention protocols are lacking. This study uniquely uses both a clinical assessment tool and musculoskeletal ultrasound to measure changes in the core muscles following an exercise intervention. The overall purpose of this study was to design a valid and reliable assessment tool and an effective training protocol to activate the core muscles.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19702
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

° Undergraduate and graduate subjects from the University of the Delaware student community.

Exclusion Criteria:

• You could be excluded if you have recently undergone surgery in the last 6 months.
• Currently suffering from low back pain.
• Or have a history of a neurological condition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rotation Exercises; 8 minute program of rotation based exercises	Other: Rotation Exercises; The subjects received 7 trunk rotation stability exercises x 10 reps each; Other Names: Sling Activation Session
ACTIVE_COMPARATOR: Control Exercises; 8 minute program of traditional exercises	Other: Control Exercises; The subjects received 7 traditional exercises x 10 reps each; Other Names: Traditional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Muscle Thickness	Musculoskeletal ultrasound measured changes in muscle thickness	Baseline and 10 minutes post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Clinical Muscle Assessment Using the Novel Sling Screen	Clinician based assessment of muscle function using the sling screen tool; Kappa coefficients were calculated to examine agreement between the 2 physical therapists that completed the sling screen assessments and to account for chance effects in scoring. A rating system was used for scoring performance. Min value on the scale is 2 and max value = 5; higher score is a better outcome.	Baseline and 10 minutes post intervention

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Investigators: Study Director: Andrea DiTrani, PhD, ATC, Neumann University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 25, 2015
• Primary Completion (ACTUAL): August 25, 2016
• Study Completion (ACTUAL): August 25, 2016

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (ACTUAL): May 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: DDD# 602910

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No