NCT02124304

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).

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

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

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, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 9, 2016

Completed
Last Updated

February 9, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

April 22, 2014

Results QC Date

September 22, 2015

Last Update Submit

January 11, 2016

Conditions

Keywords

SternocleidomastoidNeck painEMGPerceived ExertionThera-BandCervical Paraspinals

Outcome Measures

Primary Outcomes (1)

  • 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.

    One 1 hour session

Secondary Outcomes (1)

  • Perceived Exertion

    12 exercises during one 1 hour session

Study Arms (2)

Cervical Pain

EXPERIMENTAL

Thera-Band elastic and manual resistance neck exercises for neck strengthening

Device: Neck exercises using both manual and Thera-Band elasatic resistance

Healthy

EXPERIMENTAL

Thera-Band elastic and manual resistance neck exercises for neck strengthening

Device: Neck exercises using both manual and Thera-Band elasatic resistance

Interventions

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

Also known as: Thera-Band
Cervical PainHealthy

Eligibility Criteria

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

You may qualify if:

  • healthy physically active subjects (healthy group)
  • patients diagnosed with non-radicular cervical neck pain (neck pain group)

You may not qualify if:

  • current cervical or upper extremity injury (healthy group)
  • history of neck surgery
  • corticosteroid treatment within the last two weeks
  • radicular signs or 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

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jena Slaski
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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2014

First Posted

April 28, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 9, 2016

Results First Posted

February 9, 2016

Record last verified: 2016-01

Locations