Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-26 @ 1:52 AM
Study NCT ID:
NCT00929305
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2009-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elvira@reginsight.com', 'phone': '615-712-9743', 'title': 'Elvira Walls, Clinical Consultant', 'organization': 'Regulatory Insight, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo Laser', 'description': 'inactive laser light', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Erchonia PL2000', 'description': 'The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Participants Whose Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS) Decreased by 30% or More From Baseline to One Day After Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Laser', 'description': 'inactive laser light'}, {'id': 'OG001', 'title': 'Erchonia PL2000', 'description': 'The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and one day', 'description': "Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at each point in time. The higher the number marked, the greater the pain level.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Range of Motion of the Neck and Shoulders', 'timeFrame': 'one day', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Trigger Points of the Cervical Spine', 'timeFrame': 'one day', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS)From Baseline to One Day Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Laser', 'description': 'inactive laser light'}, {'id': 'OG001', 'title': 'Erchonia PL2000', 'description': 'The Erchonia EVRL Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.34', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '-28.06', 'spread': '19.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and one day', 'description': "Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at that point in time. The higher the number marked, the greater the pain level.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Laser', 'description': 'inactive laser light'}, {'id': 'FG001', 'title': 'Erchonia PL2000', 'description': 'The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period was June-July, 2001. Locations were 3 private practice test sites: 2 in California and one in Virginia.', 'preAssignmentDetails': '14 enrolled participants were subsequently excluded for taking study excluded medications, for having a self-reported pre-treatment pain Visual Analog Score (VAS) of less than 50 and for having a herniated disc injury.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Laser', 'description': 'inactive laser light'}, {'id': 'BG001', 'title': 'Erchonia PL2000', 'description': 'The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Location of Pain', 'classes': [{'title': 'Neck only', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Shoulder only', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Both Neck & Shoulder', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Pain on the right and/or left sides of the neck and/or shoulders, or both.', 'unitOfMeasure': 'participants'}, {'title': 'Origin of Pain', 'classes': [{'title': 'muscle spasms and sprain strain', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'muscle spasms only', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'osteoarthritis', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Pain originating from one or more of three etiologies: osteoarthritis; muscle spasms, sprain strain.', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Visual Analog Scale (VAS) pain rating', 'classes': [{'categories': [{'measurements': [{'value': '60.00', 'spread': '8.60', 'groupId': 'BG000'}, {'value': '60.21', 'spread': '9.84', 'groupId': 'BG001'}, {'value': '60.10', 'spread': '9.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Participants recorded a self-rating of their degree of pain in the neck-shoulder area before the study treatment was administered on the 0-100 standardized Visual Analog Scale (VAS). The VAS is a 100mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best represented the level of pain they experienced at that time in the neck-shoulder area. The higher the number marked, the greater the pain level.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Pain', 'classes': [{'categories': [{'measurements': [{'value': '82.95', 'spread': '86.14', 'groupId': 'BG000'}, {'value': '61.74', 'spread': '77.21', 'groupId': 'BG001'}, {'value': '72.35', 'spread': '82.01', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Duration in months of chronic pain in the neck and/or shoulder region.', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-02', 'studyFirstSubmitDate': '2009-06-25', 'resultsFirstSubmitDate': '2009-07-07', 'studyFirstSubmitQcDate': '2009-06-26', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-13', 'studyFirstPostDateStruct': {'date': '2009-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Participants Whose Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS) Decreased by 30% or More From Baseline to One Day After Study Treatment', 'timeFrame': 'baseline and one day', 'description': "Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at each point in time. The higher the number marked, the greater the pain level."}, {'measure': 'Change in Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS)From Baseline to One Day Post-treatment', 'timeFrame': 'baseline and one day', 'description': "Participants self-rated the degree of pain experienced in the neck-shoulder region on the 0-100 standardized Visual Analog Scale (VAS) at baseline and one day post-treatment. The VAS is a 100mm long horizontal scale ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. The participant marked the point along the scale that best showed the pain level they experienced in the neck-shoulder area at that point in time. The higher the number marked, the greater the pain level."}], 'secondaryOutcomes': [{'measure': 'Range of Motion of the Neck and Shoulders', 'timeFrame': 'one day'}, {'measure': 'Muscle Trigger Points of the Cervical Spine', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic pain', 'neck', 'shoulder', 'musculoskeletal origin'], 'conditions': ['Shoulder Pain', 'Neck Pain', 'Musculoskeletal Pain', 'Musculoskeletal Strain', 'Musculoskeletal Sprain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.accessdata.fda.gov/cdrh_docs/pdf/K012580.pdf', 'label': 'FDA 510(k)#K012580 clearance based on the results of this study'}, {'url': 'http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=17825', 'label': "FDA 510(k)#K050672 clearance based on this study's results"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine whether the application of low level laser light therapy to the neck and shoulder region is effective in reducing chronic neck and shoulder pain of musculoskeletal origin.', 'detailedDescription': 'Chronic neck and shoulder pain arising from osteoarthritis, chronic muscle spasms or thoracic or cervical spine sprain strain can be seriously debilitating. Currently available treatment options such as pain relief medication, ice pack, massage, physical therapy and chiropractic are typically of limited effectiveness. More permanent options such as surgery are invasive with long recovery periods and side-effects and complications of their own. Low level laser light therapy, with its proven anti-inflammatory ability, offers a simple non-invasive option for the reduction of chronic neck and shoulder pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Location of pain is on the right and/or left side of the neck and/or shoulder and/or the back of the neck.\n* Etiology of pain is osteoarthritis/Degenerative Joint Disorder (DJD); chronic muscle spasms or cervical and thoracic spine sprain strain, determined according to subject medical history, medication use history, previous records review, physical examination of the cervical spine and shoulder.\n* Stage of injury is chronic, having prevailed for longer than 30 days.\n* Degree of Pain self-rating of 50 or greater on the 0-100 Visual Analog Scale (VAS).\n* 18-65 years.\n\nExclusion Criteria:\n\n* Stage of injury is acute, having prevailed for less than 30 days.\n* Known herniated disc injury.\n* Any other disease or condition that may cause or contribute to the chronic pain condition.\n* Presence of infection or open wound at the treatment areas.\n* Use of steroids or narcotics.\n* Use of over-the-counter (OTC) medication for the relief of pain within the 24-hour period prior to participating in the treatment phase of the study, or prescription medication for the relief of pain within the 48-hour period prior to participating in the treatment phase of the study.\n* pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT00929305', 'briefTitle': 'Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Erchonia Corporation'}, 'officialTitle': 'Study of the Effect of Low Level Laser Therapy on the Reduction of Chronic Pain Associated With Neck and Shoulder Pain of Musculoskeletal Origin.', 'orgStudyIdInfo': {'id': 'ECP-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo laser', 'description': 'inactive laser light', 'interventionNames': ['Device: Placebo laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erchonia PL2000', 'description': 'The Erchonia PL2000 Laser emits 1 milliWatt (mW) of red (635nm wavelength) light via an electric diode energy source. It is a hand-held device that uses rechargeable batteries or a separate power adapter.', 'interventionNames': ['Device: Erchonia PL2000']}], 'interventions': [{'name': 'Erchonia PL2000', 'type': 'DEVICE', 'otherNames': ['Erchonia PL5000', 'Erchonia EVRL Laser'], 'description': 'The Erchonia PL2000 Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source. It is a hand-held device that uses rechargeable batteries or a separate power adapter.', 'armGroupLabels': ['Erchonia PL2000']}, {'name': 'Placebo laser', 'type': 'DEVICE', 'description': 'Inactive laser light', 'armGroupLabels': ['Placebo laser']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gregory C Roche, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Douglas D Dedo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Edward B Lack, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erchonia Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}