{ "FullStudy":{ "Rank":218068, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513148", "OrgStudyIdInfo":{ "OrgStudyId":"06-750" }, "Organization":{ "OrgFullName":"Shenandoah University", "OrgClass":"OTHER" }, "BriefTitle":"Effects of Light Emitting Diode Irradiation on the Conduction Parameters of the Superficial Radial Nerve", "OfficialTitle":"The Effect of Light Therapy on Superficial Radial Nerve Conduction Using a Clustered Array of Infrared Super Luminous and Red Light Emitting Diodes" }, "StatusModule":{ "StatusVerifiedDate":"July 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2006" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2008", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2008", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 9, 2012", "StudyFirstSubmitQCDate":"January 16, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"June 11, 2012", "ResultsFirstSubmitQCDate":"May 29, 2013", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"July 4, 2013", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 10, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 29, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Todd Telemeco", "ResponsiblePartyInvestigatorTitle":"Associate Professor", "ResponsiblePartyInvestigatorAffiliation":"Shenandoah University" }, "LeadSponsor":{ "LeadSponsorName":"Shenandoah University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The introduction of light emitting diode (LED) devices as a novel treatment for pain relief in place of low-level laser warrants fundamental research on the effect of LED devices on one of the potential explanatory mechanisms: peripheral neurophysiology in vivo. A randomized controlled study will be conducted by measuring nerve conduction on the superficial radial nerve of healthy subjects (n=64). One baseline measurement and five post-irradiation recordings (2-min interval each) will be performed of the nerve conduction velocity (NCV) and peak latency (PL) and peak amplitude (PA). The experimental group (=32) will receive an irradiation of 2 J/cm2 with an infrared LED device (Dynatronics Solaris Model 705), while the placebo group will be treated by sham irradiation. The purpose of this study is to investigate the effects of LED light on the conduction velocity and amplitude of the superficial radial nerve." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Peripheral Neuropathy" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"32", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Superluminous Light Diode Irradiation", "ArmGroupType":"Experimental", "ArmGroupDescription":"Application of super luminous diodes light irradiation over the superficial radial nerve", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Superluminous light diode" ] } },{ "ArmGroupLabel":"Sham Superluminous Light Diode Irradiation", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Sham Superluminous Light Diode Irradiation over the Superficial Radial Nerve for the same time period as the intervention group", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Superluminous light diode" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Superluminous light diode", "InterventionDescription":"900W, 880nm, 1.6 J/cm2 for 30sec", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Sham Superluminous Light Diode Irradiation", "Superluminous Light Diode Irradiation" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Dynatronics Solaris Model 705" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Nerve Conduction Velocity (Meters Per Second)", "PrimaryOutcomeDescription":"Change in nerve conduction velocity (m/s) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = nerve conduction velocity (NCV) - baseline NCV. A positive variance represented an increase from baseline and is interpreted as being an increase or faster velocity.", "PrimaryOutcomeTimeFrame":"pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Negative Peak Latency (Milliseconds)", "SecondaryOutcomeDescription":"Change in negative peak latency (ms) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time period = negative peak latency NPL - baseline NPL. A positive variance can be interpreted as being increase from baseline or a prolonged or slowed NPL.", "SecondaryOutcomeTimeFrame":"pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment" },{ "SecondaryOutcomeMeasure":"Temperature (Degrees C)", "SecondaryOutcomeDescription":"Change in superficial skin temperature (degrees C) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = Temperature - Temperature at baseline. A positive variance int his calculation can be interpreted as being an increase from baseline or an increase in skin temperature", "SecondaryOutcomeTimeFrame":"pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nno history of neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy\n\nExclusion Criteria:\n\npositive findings during the clinical screening examination suggestive of an underlying neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy.\na history of a neurological disease, polyneuropathy, peripheral neuropathy or cervical radiculopathy.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"50 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Todd A Telemeco, PhD", "OverallOfficialAffiliation":"Shenandoah University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Shenandoah University Divsion of Physical Therapy", "LocationCity":"Winchester", "LocationState":"Virginia", "LocationZip":"22601", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"4023064", "ReferenceType":"background", "ReferenceCitation":"Greathouse DG, Currier DP, Gilmore RL. Effects of clinical infrared laser on superficial radial nerve conduction. Phys Ther. 1985 Aug;65(8):1184-7." },{ "ReferencePMID":"4293407", "ReferenceType":"background", "ReferenceCitation":"Downie AW, Scott TR. An improved technique for radial nerve conduction studies. J Neurol Neurosurg Psychiatry. 1967 Aug;30(4):332-6." },{ "ReferencePMID":"3340661", "ReferenceType":"background", "ReferenceCitation":"Snyder-Mackler L, Bork CE. Effect of helium-neon laser irradiation on peripheral sensory nerve latency. Phys Ther. 1988 Feb;68(2):223-5." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Light Therapy", "FlowGroupDescription":"Application of super luminous diodes light irradiation over the superficial radial nerve" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Sham Irradiation", "FlowGroupDescription":"Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"16" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"14" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"2" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Light Therapy", "BaselineGroupDescription":"Application of super luminous diodes light irradiation over the superficial radial nerve" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Sham Irradiation", "BaselineGroupDescription":"Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"16" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"16" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"32" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"32" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"24.5", "BaselineMeasurementSpread":"2.1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"25.5", "BaselineMeasurementSpread":"3.9" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"24.7", "BaselineMeasurementSpread":"3.2" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"25" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"32" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Nerve Conduction Velocity (Meters Per Second)", "OutcomeMeasureDescription":"Change in nerve conduction velocity (m/s) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = nerve conduction velocity (NCV) - baseline NCV. A positive variance represented an increase from baseline and is interpreted as being an increase or faster velocity.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"m/s", "OutcomeMeasureTimeFrame":"pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Light NCV Pretreatment", "OutcomeGroupDescription":"NCV at baseline, before the application of super luminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Light NCV Time 0", "OutcomeGroupDescription":"NCV at time 0, immediately following the application of super luminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Light NCV Time 2", "OutcomeGroupDescription":"NCV 2 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Light NCV Time 4", "OutcomeGroupDescription":"NCV 4 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Light NCV Time 6", "OutcomeGroupDescription":"NCV 6 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Light NCV Time 8", "OutcomeGroupDescription":"NCV 8 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Light NCV Time 10", "OutcomeGroupDescription":"NCV 10 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Sham NCV Pretreatment", "OutcomeGroupDescription":"NCV at baseline, before the application of sham superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Sham NCV Time 0", "OutcomeGroupDescription":"NCV immediately (Time 0) following the application of superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Sham NCV Time 2", "OutcomeGroupDescription":"NCV 2 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG010", "OutcomeGroupTitle":"Sham NCV Time 4", "OutcomeGroupDescription":"NCV 4 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG011", "OutcomeGroupTitle":"Sham NCV Time 6", "OutcomeGroupDescription":"NCV 6 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG012", "OutcomeGroupTitle":"Sham NCV Time 8", "OutcomeGroupDescription":"NCV 8 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG013", "OutcomeGroupTitle":"Sham NCV Time 10", "OutcomeGroupDescription":"NCV 10 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG010", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG011", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG012", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG013", "OutcomeDenomCountValue":"14" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.000", "OutcomeMeasurementSpread":"0.000" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.358", "OutcomeMeasurementSpread":"1.200" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.447", "OutcomeMeasurementSpread":"1.616" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.147", "OutcomeMeasurementSpread":"1.785" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"-0.041", "OutcomeMeasurementSpread":"1.741" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0.280", "OutcomeMeasurementSpread":"1.801" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0.100", "OutcomeMeasurementSpread":"2.117" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.000", "OutcomeMeasurementSpread":"0.000" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"0.151", "OutcomeMeasurementSpread":"1.251" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"-0.004", "OutcomeMeasurementSpread":"1.386" },{ "OutcomeMeasurementGroupId":"OG010", "OutcomeMeasurementValue":"0.447", "OutcomeMeasurementSpread":"1.616" },{ "OutcomeMeasurementGroupId":"OG011", "OutcomeMeasurementValue":"1.116", "OutcomeMeasurementSpread":"1.530" },{ "OutcomeMeasurementGroupId":"OG012", "OutcomeMeasurementValue":"0.521", "OutcomeMeasurementSpread":"1.652" },{ "OutcomeMeasurementGroupId":"OG013", "OutcomeMeasurementValue":"0.675", "OutcomeMeasurementSpread":"2.012" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Negative Peak Latency (Milliseconds)", "OutcomeMeasureDescription":"Change in negative peak latency (ms) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time period = negative peak latency NPL - baseline NPL. A positive variance can be interpreted as being increase from baseline or a prolonged or slowed NPL.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ms", "OutcomeMeasureTimeFrame":"pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Light NPL Pre-treatment", "OutcomeGroupDescription":"NPL for treatment group (Superluminous diode light therapy) at baseline (pre-treatment)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Light NPL Time 0", "OutcomeGroupDescription":"NPL for treatment group (Superluminous diode light therapy) at time 0 minutes" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Light NPL Time 2", "OutcomeGroupDescription":"NPL for treatment group (Superluminous diode light therapy) at time 2 minutes" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Light NPL Time 4", "OutcomeGroupDescription":"NPL for treatment group (Superluminous diode light therapy) at time 4 minutes" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Light NPL Time 6", "OutcomeGroupDescription":"NPL for treatment group (Superluminous diode light therapy) at time 6 minutes" },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Light NPL Time 8", "OutcomeGroupDescription":"NPL for treatment group (Superluminous diode light therapy) at time 8 minutes" },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Light NPL Time 10", "OutcomeGroupDescription":"NPL for treatment group (Superluminous diode light therapy) at time 10 minutes" },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Sham NPL Time 0", "OutcomeGroupDescription":"NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 0 minutes" },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Sham NPL Time 2", "OutcomeGroupDescription":"NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 2 minutes" },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Sham NPL Time 4", "OutcomeGroupDescription":"NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 4 minutes" },{ "OutcomeGroupId":"OG010", "OutcomeGroupTitle":"Sham NPL Time 6", "OutcomeGroupDescription":"NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 6 minutes" },{ "OutcomeGroupId":"OG011", "OutcomeGroupTitle":"Sham NPL Time 8", "OutcomeGroupDescription":"NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 8 minutes" },{ "OutcomeGroupId":"OG012", "OutcomeGroupTitle":"Sham NPL Time 10", "OutcomeGroupDescription":"NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 10 minutes" },{ "OutcomeGroupId":"OG013", "OutcomeGroupTitle":"Sham NPL Pretreatment", "OutcomeGroupDescription":"NPL for Sham treatment group (Sham Superluminous diode light therapy) at baseline (pretreatment)" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG010", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG011", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG012", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG013", "OutcomeDenomCountValue":"14" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.000", "OutcomeMeasurementSpread":"0.000" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.414", "OutcomeMeasurementSpread":"0.429" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.007", "OutcomeMeasurementSpread":"0.070" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"-0.007", "OutcomeMeasurementSpread":"0.080" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"0.755" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"-0.014", "OutcomeMeasurementSpread":"0.083" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"-0.007", "OutcomeMeasurementSpread":"0.096" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"-0.007", "OutcomeMeasurementSpread":"0.059" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"0.000", "OutcomeMeasurementSpread":"0.065" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"-0.021", "OutcomeMeasurementSpread":"0.077" },{ "OutcomeMeasurementGroupId":"OG010", "OutcomeMeasurementValue":"-0.050", "OutcomeMeasurementSpread":"0.073" },{ "OutcomeMeasurementGroupId":"OG011", "OutcomeMeasurementValue":"-0.021", "OutcomeMeasurementSpread":"0.077" },{ "OutcomeMeasurementGroupId":"OG012", "OutcomeMeasurementValue":"-0.028", "OutcomeMeasurementSpread":"0.096" },{ "OutcomeMeasurementGroupId":"OG013", "OutcomeMeasurementValue":"0", "OutcomeMeasurementSpread":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Temperature (Degrees C)", "OutcomeMeasureDescription":"Change in superficial skin temperature (degrees C) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = Temperature - Temperature at baseline. A positive variance int his calculation can be interpreted as being an increase from baseline or an increase in skin temperature", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Degrees Celsius", "OutcomeMeasureTimeFrame":"pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Light Temp Pretreatment", "OutcomeGroupDescription":"Temperature prior to the application of super luminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Light Temp Time 0", "OutcomeGroupDescription":"Temperature immediately following the application of superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Light Temp Time 2", "OutcomeGroupDescription":"Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Light Temp Time 4", "OutcomeGroupDescription":"Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Light Temp Time 6", "OutcomeGroupDescription":"Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG005", "OutcomeGroupTitle":"Light Temp Time 8", "OutcomeGroupDescription":"Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG006", "OutcomeGroupTitle":"Light Temp Time 10", "OutcomeGroupDescription":"Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG007", "OutcomeGroupTitle":"Sham Temp Pretreatment", "OutcomeGroupDescription":"Temperature prior to the application of sham super luminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG008", "OutcomeGroupTitle":"Sham Temp Time 0", "OutcomeGroupDescription":"Temperature immediately following the application of sham superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG009", "OutcomeGroupTitle":"Sham Temp Time 2", "OutcomeGroupDescription":"Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG010", "OutcomeGroupTitle":"Sham Temp Time 4", "OutcomeGroupDescription":"Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG011", "OutcomeGroupTitle":"Sham Temp Time 6", "OutcomeGroupDescription":"Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG012", "OutcomeGroupTitle":"Sham Temp Time 8", "OutcomeGroupDescription":"Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve" },{ "OutcomeGroupId":"OG013", "OutcomeGroupTitle":"Sham Temp Time 10", "OutcomeGroupDescription":"Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG005", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG006", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG007", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG008", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG009", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG010", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG011", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG012", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG013", "OutcomeDenomCountValue":"14" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.000", "OutcomeMeasurementSpread":"0.000" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.414", "OutcomeMeasurementSpread":"0.429" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.993", "OutcomeMeasurementSpread":"0.626" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0.686", "OutcomeMeasurementSpread":"1.210" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"0.757", "OutcomeMeasurementSpread":"1.336" },{ "OutcomeMeasurementGroupId":"OG005", "OutcomeMeasurementValue":"0.786", "OutcomeMeasurementSpread":"1.341" },{ "OutcomeMeasurementGroupId":"OG006", "OutcomeMeasurementValue":"0.778", "OutcomeMeasurementSpread":"1.432" },{ "OutcomeMeasurementGroupId":"OG007", "OutcomeMeasurementValue":"0.000", "OutcomeMeasurementSpread":"0.000" },{ "OutcomeMeasurementGroupId":"OG008", "OutcomeMeasurementValue":"0.814", "OutcomeMeasurementSpread":"0.662" },{ "OutcomeMeasurementGroupId":"OG009", "OutcomeMeasurementValue":"1.021", "OutcomeMeasurementSpread":"0.591" },{ "OutcomeMeasurementGroupId":"OG010", "OutcomeMeasurementValue":"0.993", "OutcomeMeasurementSpread":"0.626" },{ "OutcomeMeasurementGroupId":"OG011", "OutcomeMeasurementValue":"1.007", "OutcomeMeasurementSpread":"0.796" },{ "OutcomeMeasurementGroupId":"OG012", "OutcomeMeasurementValue":"0.928", "OutcomeMeasurementSpread":"0.820" },{ "OutcomeMeasurementGroupId":"OG013", "OutcomeMeasurementValue":"0.878", "OutcomeMeasurementSpread":"0.847" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Light Therapy", "EventGroupDescription":"Application of super luminous diodes light irradiation over the superficial radial nerve", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"16" },{ "EventGroupId":"EG001", "EventGroupTitle":"Sham Irradiation", "EventGroupDescription":"Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"16", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"16" } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Dr. Todd Telemeco", "PointOfContactOrganization":"Shenandoah University", "PointOfContactEMail":"ttelemec@su.edu", "PointOfContactPhone":"540-545-7398" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000010523", "ConditionMeshTerm":"Peripheral Nervous System Diseases" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009468", "ConditionAncestorTerm":"Neuromuscular Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M12015", "ConditionBrowseLeafName":"Peripheral Nervous System Diseases", "ConditionBrowseLeafAsFound":"Peripheral Neuropathy", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10994", "ConditionBrowseLeafName":"Neuromuscular Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }