Cervical Activation During Elastic and Manual Resistance (CervEMG)

• ClinicalTrials.gov Identifier: NCT02124304
• Recruitment Status: Completed
• First Posted: April 28, 2014
• Results First Posted: February 9, 2016
• Last Update Posted: February 9, 2016
• Sponsor: Sport and Spine Rehab Clinical Research Foundation
• Information provided by (Responsible Party): Sport and Spine Rehab Clinical Research Foundation

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).

Condition or disease	Intervention/treatment	Phase
Cervical Pain	Device: Neck exercises using both manual and Thera-Band elasatic resistance	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: EMG Activation of Cervical Musculature During Therapeutic Exercise With Thera-Band(R) Resistance Versus Manual Resistance
• Study Start Date: April 2014
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: August 2014

Arms and Interventions

Arm	Intervention/treatment
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 Name: 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 Name: Thera-Band

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Maryland

Sport & Spine Rehab

Rockville, Maryland, United States, 20852

Sponsors and Collaborators

Sport and Spine Rehab Clinical Research Foundation

Investigators

• Principal Investigator: Barton Bishop, DPT; Sport & Spine Rehab Clinical Research Foundation

More Information

• Responsible Party: Sport and Spine Rehab Clinical Research Foundation
• ClinicalTrials.gov Identifier: NCT02124304
• Other Study ID Numbers: SSR04
• First Posted: April 28, 2014
• Results First Posted: February 9, 2016
• Last Update Posted: February 9, 2016
• Last Verified: January 2016

Keywords provided by Sport and Spine Rehab Clinical Research Foundation:

Sternocleidomastoid; Neck pain; EMG; Perceived Exertion; Thera-Band; Cervical Paraspinals

Additional relevant MeSH terms:

Neck Pain; Pain; Neurologic Manifestations