{ "FullStudy":{ "Rank":217813, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516502", "OrgStudyIdInfo":{ "OrgStudyId":"98-0569B" }, "Organization":{ "OrgFullName":"Chang Gung Memorial Hospital", "OrgClass":"OTHER" }, "BriefTitle":"The Efficacy of Low-level Laser on Cervical Myofascial Pain Syndrome", "OfficialTitle":"Is Low-level Laser on Traditional Acupoint as Effective as That on Trigger Point in the Management of Cervical Myofascial Pain Syndrome?" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"October 19, 2011", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 24, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 25, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Alice May-Kuen Wong", "ResponsiblePartyInvestigatorTitle":"professor", "ResponsiblePartyInvestigatorAffiliation":"Chang Gung Memorial Hospital" }, "LeadSponsor":{ "LeadSponsorName":"Chang Gung Memorial Hospital", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Objective: To compare the effectiveness of application of low-level laser therapy (LLLT) to trigger points and traditional acupoints for patients with cervical myofascial pain syndrome (MPS).\n\nDesign: A single-blinded, randomized, placebo-controlled trial Setting: University rehabilitation hospital Participants: One hundred and twenty one patients with cervical MPS Intervention: The investigators performed this experiment using low level 810-nm gallium aluminum arsenide (Ga-Al-As) laser. One hundred participants were randomly assigned to four treatment groups, including (1) acupoint therapy (2) acupoint control (3) trigger point therapy and (4) trigger point control groups.\n\nMain Outcome measures: The investigators evaluated the patient's visual analogue scale (VAS) pain scores, pressure pain threshold and cervical range of motion (ROM) before and after the therapy.", "DetailedDescription":"Low level laser therapy (LLLT) has been promoted since 1960s. It was clinically applied on neurological, musculoskeletal and soft tissue disorders, with the effects such as acceleration of wound healing, edema reduction in human flexor tendon injuries, improvement of morning stiffness, and pain relief in rheumatoid arthritis and lateral epicondylitis. As for relief of musculoskeletal pain, however, the effect of LLLT is controversial. Some studies reported that LLLT was a safe and effective treatment for relief of musculoskeletal pain, while others considered LLLT as ineffective in treating certain musculoskeletal diseases.\n\nLLLT has been used to stimulate traditional acupoints, which is denoted as laser acupuncture. In addition to pain relief, laser acupuncture has been reported to be effective in a variety of disorders such as intractable hiccups,enuresis, as well as weight reduction. Nevertheless, the underlying mechanisms and modes of application of laser acupuncture remain unclear.\n\nThere has been evidence that needle acupuncture on traditional acupoints or trigger points may ease neck pain. However, needle acupuncture has some limitations because it is an invasive procedure with risk of infection or pneumothorax. Besides, some patients were not able to tolerate the discomfort from needle manipulation during acupuncture therapy.\n\nLLLT is a type of non-invasive painless therapy and hence a good alternative to needle acupuncture. LLLT has been used to treat neck pain since 1981 and demonstrated significant reduction of pain intensity and improvement of cervical range of motion (ROM) in patients with cervical myofascial pain syndrome (MPS). In most of the studies on LLLT and cervical MPS, trigger points were chosen as the application area domain for LLLT. However, there is no report yet to compare the effectiveness of LLLT on trigger points and traditional acupoints.\n\nIn the present single-blinded, randomized, controlled study, the investigators aimed to investigate the effectiveness of application of LLLT to the trigger points and traditional acupoints in patients with cervical MPS. The outcome measurement was pain relief and the improvement of cervical ROM, on which the findings could provide in-depth understanding of the therapeutic mechanism of LLLT and further allow more flexible options of clinical application." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Myofacial Pain Syndromes" ] }, "KeywordList":{ "Keyword":[ "laser therapy", "myofascial pain syndrome", "acupoint", "trigger point", "range of motion" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Factorial Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"100", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"laser to acupoint", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: low-level laser therapy" ] } },{ "ArmGroupLabel":"sham laser to acupoint", "ArmGroupType":"Sham Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: low-level laser therapy" ] } },{ "ArmGroupLabel":"laser to trigger point", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: low-level laser therapy" ] } },{ "ArmGroupLabel":"sham laser to trigger point", "ArmGroupType":"Sham Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: low-level laser therapy" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"low-level laser therapy", "InterventionDescription":"An infrared (the low-level laser, class IIIb) gallium aluminum arsenide (Ga-Al-As) diode laser device (MediUm-TECH Medizingeräte GmbH, Germany) with a wavelength of 810nm and a maximum power output of 150mW in the continuous wave mode", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "laser to acupoint", "laser to trigger point", "sham laser to acupoint", "sham laser to trigger point" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "low-power laser therapy" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"1.pain scores", "PrimaryOutcomeDescription":"1. pain score: visual analog scale (VAS)", "PrimaryOutcomeTimeFrame":"10 minutes" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"2. pressure pain threshold at the trigger point", "SecondaryOutcomeDescription":"2. pressure pain threshold at the trigger point", "SecondaryOutcomeTimeFrame":"10 minutes" },{ "SecondaryOutcomeMeasure":"3. cervical range of motion", "SecondaryOutcomeDescription":"3. cervical range of motion: flexion, extension, bending and rotation", "SecondaryOutcomeTimeFrame":"10 minutes" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\ncomplaint of regional pain in the neck,\npresence of a palpable taut band,\npresence of a tender spot along the length of taut ban, and\nreproduction or enhancement of the clinical symptoms by compression of the active trigger point\n\nExclusion Criteria:\n\ncervical spine lesion, such as radiculopathy or myelopathy,\nfracture or surgery of cervical spine,\ncervical spine instability, and\ncognitive deficits or psychiatric illness", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Alice.M.K Wong, Professor", "OverallOfficialAffiliation":"Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Taoyuan, Taoyuan, Taiwan", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Chang Gung Memorial Hospital", "LocationCity":"TaoYuan county", "LocationZip":"333", "LocationCountry":"Taiwan" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009209", "ConditionMeshTerm":"Myofascial Pain Syndromes" },{ "ConditionMeshId":"D000005356", "ConditionMeshTerm":"Fibromyalgia" },{ "ConditionMeshId":"D000005156", "ConditionMeshTerm":"Facial Neuralgia" },{ "ConditionMeshId":"D000013577", "ConditionMeshTerm":"Syndrome" },{ "ConditionMeshId":"D000005157", "ConditionMeshTerm":"Facial Pain" },{ "ConditionMeshId":"D000013001", "ConditionMeshTerm":"Somatoform Disorders" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000004194", "ConditionAncestorTerm":"Disease" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000001523", "ConditionAncestorTerm":"Mental Disorders" },{ "ConditionAncestorId":"D000009135", "ConditionAncestorTerm":"Muscular Diseases" },{ "ConditionAncestorId":"D000009140", "ConditionAncestorTerm":"Musculoskeletal Diseases" },{ "ConditionAncestorId":"D000012216", "ConditionAncestorTerm":"Rheumatic Diseases" },{ "ConditionAncestorId":"D000009468", "ConditionAncestorTerm":"Neuromuscular Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000010146", "ConditionAncestorTerm":"Pain" },{ "ConditionAncestorId":"D000009461", "ConditionAncestorTerm":"Neurologic Manifestations" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" },{ "ConditionAncestorId":"D000005155", "ConditionAncestorTerm":"Facial Nerve Diseases" },{ "ConditionAncestorId":"D000009059", "ConditionAncestorTerm":"Mouth Diseases" },{ "ConditionAncestorId":"D000009057", "ConditionAncestorTerm":"Stomatognathic Diseases" },{ "ConditionAncestorId":"D000003389", "ConditionAncestorTerm":"Cranial Nerve Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14938", "ConditionBrowseLeafName":"Syndrome", "ConditionBrowseLeafAsFound":"Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M11649", "ConditionBrowseLeafName":"Pain", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10744", "ConditionBrowseLeafName":"Myofascial Pain Syndromes", "ConditionBrowseLeafAsFound":"Myofascial Pain Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M7069", "ConditionBrowseLeafName":"Fibromyalgia", "ConditionBrowseLeafAsFound":"Myofascial Pain Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10964", "ConditionBrowseLeafName":"Neuralgia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M19673", "ConditionBrowseLeafName":"Facies", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6882", "ConditionBrowseLeafName":"Facial Neuralgia", "ConditionBrowseLeafAsFound":"Myofacial Pain Syndromes", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M6883", "ConditionBrowseLeafName":"Facial Pain", "ConditionBrowseLeafAsFound":"Myofacial Pain", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14386", "ConditionBrowseLeafName":"Somatoform Disorders", "ConditionBrowseLeafAsFound":"Pain Syndrome", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3396", "ConditionBrowseLeafName":"Mental Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13056", "ConditionBrowseLeafName":"Psychotic Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10675", "ConditionBrowseLeafName":"Muscular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10680", "ConditionBrowseLeafName":"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13628", "ConditionBrowseLeafName":"Rheumatic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4906", "ConditionBrowseLeafName":"Collagen Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10994", "ConditionBrowseLeafName":"Neuromuscular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10987", "ConditionBrowseLeafName":"Neurologic Manifestations", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6881", "ConditionBrowseLeafName":"Facial Nerve Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10602", "ConditionBrowseLeafName":"Mouth Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10600", "ConditionBrowseLeafName":"Stomatognathic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5188", "ConditionBrowseLeafName":"Cranial Nerve Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC05", "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC07", "ConditionBrowseBranchName":"Mouth and Tooth Diseases" },{ "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" } ] } } } } } }