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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Sport & Spine Rehab

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cervical Pain
Thera-Band elastic and manual resistance neck exercises for neck strengthening
Device: Neck exercises using both manual and Thera-Band elasatic resistance
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:
  • Thera-Band
Experimental: Healthy
Thera-Band elastic and manual resistance neck exercises for neck strengthening
Device: Neck exercises using both manual and Thera-Band elasatic resistance
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:
  • Thera-Band

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
One 1 hour session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Exertion
Time Frame: 12 exercises during one 1 hour session
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.
12 exercises during one 1 hour session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sport and Spine Rehab Clinical Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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