Cervical PainCervEMGNCT02124304
Cervical Activation During Elastic and Manual Resistance
A study testing Neck exercises using both manual and Thera-Band elasatic resistance in people with Cervical Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Neck exercises using both manual and Thera-Band elasatic resistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy physically active subjects (healthy group)
- patients diagnosed with non-radicular cervical neck pain (neck pain group)
- 18-65
Who cannot join
- current cervical or upper extremity injury (healthy group)
- history of neck surgery
- corticosteroid treatment within the last two weeks
- radicular signs or symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Cervical Pain
- Being tested
- Neck exercises using both manual and Thera-Band elasatic resistance
- Keywords
- Sternocleidomastoid, Neck pain, EMG, Perceived Exertion, Thera-Band, Cervical Paraspinals
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck exercises using both manual and Thera-Band elasatic resistanceDevice
Also called Thera-Band
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
| Study group | Role | What they receive |
|---|---|---|
| Cervical Pain | Experimental | Thera-Band elastic and manual resistance neck exercises for neck strengthening Receives: Device: Neck exercises using both manual and Thera-Band elasatic resistance |
| Healthy | Experimental | Thera-Band elastic and manual resistance neck exercises for neck strengthening Receives: Device: Neck exercises using both manual and Thera-Band elasatic resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One 1 hour session
Secondary outcomes (1)
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.
Measured: 12 exercises during one 1 hour session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barton Bishop, DPT, Principal investigator, Sport & Spine Rehab Clinical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124304
- Sponsor's protocol ID
- SSR04
- Acronym
- CervEMG
- Status last verified
- Jan 2016
- First submitted
- 22 Apr 2014
- Last updated
- 9 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMG Activation of Cervical Musculature During Therapeutic Exercise With Thera-Band(R) Resistance Versus Manual Resistance
- ClinicalTrials.gov ID
- NCT02124304
- Acronym / sponsor ID
- CervEMG / SSR04
- Conditions
- Cervical Pain
- Keywords
- Sternocleidomastoid, Neck pain, EMG, Perceived Exertion, Thera-Band, Cervical Paraspinals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Posted 9 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical Pain | Experimental | Device: Neck exercises using both manual and Thera-Band elasatic resistanceThera-Band elastic and manual resistance neck exercises for neck strengthening |
| Healthy | Experimental | Device: Neck exercises using both manual and Thera-Band elasatic resistanceThera-Band elastic and manual resistance neck exercises for neck strengthening |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy physically active subjects (healthy group)
- patients diagnosed with non-radicular cervical neck pain (neck pain group)
- 18-65
Key exclusion criteria (4 listed)
- current cervical or upper extremity injury (healthy group)
- history of neck surgery
- corticosteroid treatment within the last two weeks
- radicular signs or symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck exercises using both manual and Thera-Band elasatic resistanceAlso: Thera-BandExercises 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 | Device | Cervical Pain, Healthy |
Primary outcome
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.
1 secondary outcome
Perceived Exertion
Time frame: 12 exercises during one 1 hour session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barton Bishop, DPT principal investigator
Sport & Spine Rehab Clinical Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck exercises using both manual and Thera-Band elasatic resistance in people with Cervical Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Peak Activation (%PA) (time frame: One 1 hour session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.