NCT01841216

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 3, 2015

Completed
Last Updated

February 3, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

April 23, 2013

Results QC Date

December 30, 2014

Last Update Submit

January 30, 2015

Conditions

Keywords

Gluteus MaximusGluteus MediusTFLEMGPerceived ExertionThera-Band

Outcome Measures

Primary Outcomes (1)

  • 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.

    One 40 minute session

Secondary Outcomes (1)

  • Perceived Exertion

    16 exercises during one 40 minute session

Study Arms (2)

Low Back Pain

EXPERIMENTAL

Lower Body Exercises with and without resistance

Device: Lower Body Exercises with and without resistance

Healthy

EXPERIMENTAL

Lower Body Exercises with and without resistance

Device: Lower Body Exercises with and without resistance

Interventions

lower body exercises with and without resistance designed to activate the gluteal/hip musculature

HealthyLow Back Pain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport & Spine Rehab

Rockville, Maryland, 20852, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jena Etnoyer, Clinical Research Coordinator
Organization
Sport & Spine Rehab Clinical Research Foundation

Study Officials

  • Barton Bishop, DPT

    Sport & Spine Rehab Clinical Research Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

April 26, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 3, 2015

Results First Posted

February 3, 2015

Record last verified: 2015-01

Locations