Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-20 @ 7:21 PM
Study NCT ID:
NCT02124304
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2014-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cervical Activation During Elastic and Manual Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jslaski@ssrehab.com', 'phone': '301-251-2777', 'title': 'Jena Slaski', 'phoneExt': '838', 'organization': 'Sport & Spine Rehab Clinical Research Foundation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cervical Neck Pain', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening\n\nNeck 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', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening\n\nNeck 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', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Peak Activation (%PA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervical Pain', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening\n\nNeck 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'}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening\n\nNeck 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. 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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.', 'unitOfMeasure': 'Percentage of Peak Activation (%PA)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Exertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cervical Pain', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening\n\nNeck 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'}, {'id': 'OG001', 'title': 'Healthy', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening\n\nNeck 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'}], 'classes': [{'title': 'Flexion Manual', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '7'}]}]}, {'title': 'Extension Manual', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '7'}]}]}, {'title': 'Flexion Elastic', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '8'}]}]}, {'title': 'Extension Elastic', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'Right Rotation Manual', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Left Rotation Manual', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'Right Rotation Elastic', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'Left Rotation Elastic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}]}]}, {'title': 'Right SideBending Manual', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '9'}]}]}, {'title': 'Left SideBending Manual', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Right SideBending Elastic', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}, {'title': 'Left SideBending Elastic', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 exercises during one 1 hour session', '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.', 'unitOfMeasure': 'units on a scale, ranging from 0 to 10', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cervical Neck Pain', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening\n\nNeck 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'}, {'id': 'FG001', 'title': 'Healthy', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening\n\nNeck 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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cervical Neck Pain', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening\n\nNeck 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'}, {'id': 'BG001', 'title': 'Healthy', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening\n\nNeck 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'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '47'}, {'value': '28.1', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '36'}, {'value': '29.95', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '47'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-11', 'studyFirstSubmitDate': '2014-04-22', 'resultsFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-11', 'studyFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Peak Activation (%PA)', 'timeFrame': 'One 1 hour session', '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.'}], 'secondaryOutcomes': [{'measure': 'Perceived Exertion', 'timeFrame': '12 exercises during one 1 hour session', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sternocleidomastoid', 'Neck pain', 'EMG', 'Perceived Exertion', 'Thera-Band', 'Cervical Paraspinals'], 'conditions': ['Cervical Pain']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy physically active subjects (healthy group)\n* patients diagnosed with non-radicular cervical neck pain (neck pain group)\n* 18-65\n\nExclusion Criteria:\n\n* current cervical or upper extremity injury (healthy group)\n* history of neck surgery\n* corticosteroid treatment within the last two weeks\n* radicular signs or symptoms'}, 'identificationModule': {'nctId': 'NCT02124304', 'acronym': 'CervEMG', 'briefTitle': 'Cervical Activation During Elastic and Manual Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Sport and Spine Rehab Clinical Research Foundation'}, 'officialTitle': 'EMG Activation of Cervical Musculature During Therapeutic Exercise With Thera-Band(R) Resistance Versus Manual Resistance', 'orgStudyIdInfo': {'id': 'SSR04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cervical Pain', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening', 'interventionNames': ['Device: Neck exercises using both manual and Thera-Band elasatic resistance']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy', 'description': 'Thera-Band elastic and manual resistance neck exercises for neck strengthening', 'interventionNames': ['Device: Neck exercises using both manual and Thera-Band elasatic resistance']}], 'interventions': [{'name': 'Neck exercises using both manual and Thera-Band elasatic resistance', 'type': 'DEVICE', 'otherNames': ['Thera-Band'], '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', 'armGroupLabels': ['Cervical Pain', 'Healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20852', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sport & Spine Rehab', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}], 'overallOfficials': [{'name': 'Barton Bishop, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sport & Spine Rehab Clinical Research Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sport and Spine Rehab Clinical Research Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}