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EMG Activation of Gluteal Musculature During Exercises With and Without Resistance (GlutEMG02)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lower Body Exercises with and without resistance
Sponsored by
Sport and Spine Rehab Clinical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Back Pain focused on measuring Gluteus Maximus, Gluteus Medius, TFL, EMG, Perceived Exertion, Thera-Band

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy, physically active subjects
  • patients diagnosed with non-radicular low back pain
  • 18-65

Exclusion Criteria:

  • current low back or lower extremity injury (healthy group)
  • pregnancy
  • history of hip surgery
  • radicular symptoms

Sites / Locations

  • Sport & Spine Rehab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Back Pain

Healthy

Arm Description

Lower Body Exercises with and without resistance

Lower Body Exercises with and without resistance

Outcomes

Primary Outcome Measures

Percent of Maximal Voluntary Isometric Contraction (%MVIC)
Percent of Maximal Voluntary Isometric Contraction was measured by placing EMG leads on selected muscles. Data was collected and analyzed with the MyoResearch XP Masters Edition (Noraxam Inc., Scottsdale, AZ). The EMG signals were smoothed and rectified and analyzed using a root-mean-square algorithm. We used visual onset and offset of the EMG signal amplitude to select the middle 3 of 5 trials. The middle three repetitions were analyzed. Average activation and peak activation were determined and then compared to the maximum voluntary isometric contraction (MVIC), captured during a manual muscle test, for each muscle group, and expressed as a %MVIC. The %MVIC can be greater than 100% since the MVIC is captured in a stationary, isometric position using manual force and all other activities are performed in motion against elastic or gravity resistance.

Secondary Outcome Measures

Perceived Exertion
Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises. This is a scale 0 to 10, 0 being extremely easy and 10 being extremely hard. The subject rated the intensity or resistance felt on each exercise on this scale. The ideal range for an exercise is in the middle of the scale (4-7) where the subject is feeling resistance but is not maximally exerted.

Full Information

First Posted
April 23, 2013
Last Updated
January 30, 2015
Sponsor
Sport and Spine Rehab Clinical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01841216
Brief Title
EMG Activation of Gluteal Musculature During Exercises With and Without Resistance
Acronym
GlutEMG02
Official Title
EMG Activation of Gluteal Musculature and Perceived Exertion During Therapeutic Exercises With and Without Thera-Band® Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sport and Spine Rehab Clinical Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The gluteus medius (Gmed) and gluteus maximus (Gmax) muscles are important components in the treatment of many lower limb injuries. Recent studies have evaluated a myriad of exercises which activate the Gmed and Gmax, but limited research remains on exercises involving resistance and the role of the TFL. The purpose of this study is to evaluate Gmed, Gmax, and TFL percent maximal voluntary isometric contraction (%MVIC) and perceived exertion in healthy and low back pain patients while performing exercises with and without resistance. Methods: A convenience sample of healthy subjects and patients diagnosed with non-radicular low back pain will be recruited. Exclusionary criteria will include: current low back or lower extremity injury (healthy group), pregnancy, history of hip surgery, and radicular symptoms. Surface electromyography will be used to quantify the activity level of the gluteal muscles and TFL while performing a series of 8 exercises with and without Thera-Band® Resistance Tubing and Stability Trainer. The maximal voluntary isometric contraction (MVIC) will be established for each muscle group and the order of exercises performed will be randomized to minimize the effect of fatigue. Following the completion of each exercise, the patient will rate their perceived exertion level on the Thera-Band® Resistance Intensity Scale for Exercise (RISE). The EMG signals will be smoothed and rectified and analyzed using a root-mean-square algorithm. Clinical Relevance: The results of this study will allow clinicians to better prescribe exercises, proven to activate the gluteal muscles and limit the TFL involvement, in the treatment of low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Gluteus Maximus, Gluteus Medius, TFL, EMG, Perceived Exertion, Thera-Band

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Back Pain
Arm Type
Experimental
Arm Description
Lower Body Exercises with and without resistance
Arm Title
Healthy
Arm Type
Experimental
Arm Description
Lower Body Exercises with and without resistance
Intervention Type
Device
Intervention Name(s)
Lower Body Exercises with and without resistance
Intervention Description
lower body exercises with and without resistance designed to activate the gluteal/hip musculature
Primary Outcome Measure Information:
Title
Percent of Maximal Voluntary Isometric Contraction (%MVIC)
Description
Percent of Maximal Voluntary Isometric Contraction was measured by placing EMG leads on selected muscles. Data was collected and analyzed with the MyoResearch XP Masters Edition (Noraxam Inc., Scottsdale, AZ). The EMG signals were smoothed and rectified and analyzed using a root-mean-square algorithm. We used visual onset and offset of the EMG signal amplitude to select the middle 3 of 5 trials. The middle three repetitions were analyzed. Average activation and peak activation were determined and then compared to the maximum voluntary isometric contraction (MVIC), captured during a manual muscle test, for each muscle group, and expressed as a %MVIC. The %MVIC can be greater than 100% since the MVIC is captured in a stationary, isometric position using manual force and all other activities are performed in motion against elastic or gravity resistance.
Time Frame
One 40 minute session
Secondary Outcome Measure Information:
Title
Perceived Exertion
Description
Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises. This is a scale 0 to 10, 0 being extremely easy and 10 being extremely hard. The subject rated the intensity or resistance felt on each exercise on this scale. The ideal range for an exercise is in the middle of the scale (4-7) where the subject is feeling resistance but is not maximally exerted.
Time Frame
16 exercises during one 40 minute session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy, physically active subjects patients diagnosed with non-radicular low back pain 18-65 Exclusion Criteria: current low back or lower extremity injury (healthy group) pregnancy history of hip surgery radicular symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barton Bishop, DPT
Organizational Affiliation
Sport & Spine Rehab Clinical Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sport & Spine Rehab
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States

12. IPD Sharing Statement

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EMG Activation of Gluteal Musculature During Exercises With and Without Resistance

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