Cervical Activation During Elastic and Manual Resistance (CervEMG)
Primary Purpose
Cervical Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neck exercises using both manual and Thera-Band elasatic resistance
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Pain focused on measuring Sternocleidomastoid, Neck pain, EMG, Perceived Exertion, Thera-Band, Cervical Paraspinals
Eligibility Criteria
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
Sites / Locations
- Sport & Spine Rehab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cervical Pain
Healthy
Arm Description
Thera-Band elastic and manual resistance neck exercises for neck strengthening
Thera-Band elastic and manual resistance neck exercises for neck strengthening
Outcomes
Primary Outcome Measures
Percent of Peak Activation (%PA)
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.
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. 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.
Full Information
NCT ID
NCT02124304
First Posted
April 22, 2014
Last Updated
January 11, 2016
Sponsor
Sport and Spine Rehab Clinical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02124304
Brief Title
Cervical Activation During Elastic and Manual Resistance
Acronym
CervEMG
Official Title
EMG Activation of Cervical Musculature During Therapeutic Exercise With Thera-Band(R) Resistance Versus Manual Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Pain
Keywords
Sternocleidomastoid, Neck pain, EMG, Perceived Exertion, Thera-Band, Cervical Paraspinals
7. Study Design
Primary Purpose
Treatment
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
Cervical Pain
Arm Type
Experimental
Arm Description
Thera-Band elastic and manual resistance neck exercises for neck strengthening
Arm Title
Healthy
Arm Type
Experimental
Arm Description
Thera-Band elastic and manual resistance neck exercises for neck strengthening
Intervention Type
Device
Intervention Name(s)
Neck exercises using both manual and Thera-Band elasatic resistance
Other Intervention Name(s)
Thera-Band
Intervention Description
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
Primary Outcome Measure Information:
Title
Percent of Peak Activation (%PA)
Description
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.
Time Frame
One 1 hour 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. 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.
Time Frame
12 exercises during one 1 hour 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 (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
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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Cervical Activation During Elastic and Manual Resistance
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