- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02124304
Cervical Activation During Elastic and Manual Resistance (CervEMG)
January 11, 2016 updated by: Sport and Spine Rehab Clinical Research Foundation
EMG Activation of Cervical Musculature During Therapeutic Exercise With Thera-Band(R) Resistance Versus Manual Resistance
Cervical pain is a condition that affects 14.6% of all adults annually.
Of this annual prevalence, 37.3% experience persistent neck pain with periodic recurring episodes.
The purpose of this study is to compare muscle activation patterns of the cervical musculature during exercises with elastic versus manual resistance in a neck pain and asymptomatic populations.
Methods: A convenience sample of 15 healthy, physically active participants and 15 current patients diagnosed with non-radicular cervical pain will be recruited.
Exclusionary criteria will include: current cervical or upper extremity injury (healthy group), history of neck surgery, corticosteroid treatment within the last two weeks, and radicular signs or symptoms.
Surface electromyography will be used to quantify the activity level of the bilateral SCM, AS, Cervical Paraspinal (CP), and the Upper Trapezius (UT) muscles while performing a series of 6 exercises with elastic resistance using Thera-Band® Resistance Bands and manual resistance.
The area will be prepped and surface electrodes placed on the corresponding muscles.
The movement will be standardized by using the peak activation (PA) of each muscle during full flexion-extension movement to create a percentage of peak activation (%PA).
The testing battery will consist of 6 exercises with elastic resistance and manual resistance, totaling 12 different trials.
Each trial will involve 5 repetitions, each held for 5 seconds.
The exercises will include cervical: extension, flexion, left rotation, right rotation, left side bending, and right side bending.
The men will use the green and women will use the red Thera-Band® Resistance Band.
The order of exercises will be randomized in to two parts to minimize the effect of fatigue.
First, cervical flexion and extension with manual and elastic resistance will be randomized.
Secondly, the remaining 8 exercises will be randomized.
Following each exercise, the patient will rate their perceived level of exertion on the Thera-band® Resistance Intensity Scale for Exercise (RISE).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Rockville, Maryland, United States, 20852
- Sport & Spine Rehab
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy physically active subjects (healthy group)
- patients diagnosed with non-radicular cervical neck pain (neck pain group)
- 18-65
Exclusion Criteria:
- current cervical or upper extremity injury (healthy group)
- history of neck surgery
- corticosteroid treatment within the last two weeks
- radicular signs or symptoms
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cervical Pain
Thera-Band elastic and manual resistance neck exercises for neck strengthening
|
Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation.
All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it.
Thera-Band bands will be used to provide elastic resistance
Other Names:
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Experimental: Healthy
Thera-Band elastic and manual resistance neck exercises for neck strengthening
|
Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation.
All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it.
Thera-Band bands will be used to provide elastic resistance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Peak Activation (%PA)
Time Frame: One 1 hour session
|
8 muscles during 12 exercises were analyzed in 30 subjects, totaling 2880 data points.
At the beginning of the study, peak activation (PA) was assessed for each muscle during full flexion-extension, used as a reference exercise.
For each subject, the EMG signals of the muscles during the 12 exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used.
After the PA for each muscle was determined, it was compared to the PA of the reference exercise for the respective muscle group, and expressed as a percent of the peak activation (%PA).
In some cases the %PA is greater than 100%.
This is possible as the PA was assessed during a full flexion-extension movement.
During an exercise some muscles generated greater PA and therefore when the calculations were performed the %PA was greater than 100%.
Due to the extensive amount of data, we have provided the Left Cervical Paraspinals %PA results for each exercise.
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One 1 hour session
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Exertion
Time Frame: 12 exercises during one 1 hour session
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Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises.
Participants were asked to rate the intensity of an exercise on a scale from 0 to 10, 0 being no resistance and 10 being the maximum resistance.
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12 exercises during one 1 hour session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Barton Bishop, DPT, Sport & Spine Rehab Clinical Research Foundation
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
April 22, 2014
First Submitted That Met QC Criteria
April 24, 2014
First Posted (Estimate)
April 28, 2014
Study Record Updates
Last Update Posted (Estimate)
February 9, 2016
Last Update Submitted That Met QC Criteria
January 11, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSR04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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