Nctid:
NCT00000394
Payload:
{"FullStudy"=>{"Rank"=>498932, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000002349", "ConditionMeshTerm"=>"Carpal Tunnel Syndrome"}, {"ConditionMeshId"=>"D000013577", "ConditionMeshTerm"=>"Syndrome"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000004194", "ConditionAncestorTerm"=>"Disease"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000020423", "ConditionAncestorTerm"=>"Median Neuropathy"}, {"ConditionAncestorId"=>"D000020422", "ConditionAncestorTerm"=>"Mononeuropathies"}, {"ConditionAncestorId"=>"D000010523", "ConditionAncestorTerm"=>"Peripheral Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009468", "ConditionAncestorTerm"=>"Neuromuscular Diseases"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}, {"ConditionAncestorId"=>"D000009408", "ConditionAncestorTerm"=>"Nerve Compression Syndromes"}, {"ConditionAncestorId"=>"D000012090", "ConditionAncestorTerm"=>"Cumulative Trauma Disorders"}, {"ConditionAncestorId"=>"D000013180", "ConditionAncestorTerm"=>"Sprains and Strains"}, {"ConditionAncestorId"=>"D000014947", "ConditionAncestorTerm"=>"Wounds and Injuries"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M16355", "ConditionBrowseLeafName"=>"Syndrome", "ConditionBrowseLeafAsFound"=>"Syndrome", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M5603", "ConditionBrowseLeafName"=>"Carpal Tunnel Syndrome", "ConditionBrowseLeafAsFound"=>"Carpal Tunnel Syndrome", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M22219", "ConditionBrowseLeafName"=>"Median Neuropathy", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M22218", "ConditionBrowseLeafName"=>"Mononeuropathies", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13432", "ConditionBrowseLeafName"=>"Peripheral Nervous System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12411", "ConditionBrowseLeafName"=>"Neuromuscular Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12352", "ConditionBrowseLeafName"=>"Nerve Compression Syndromes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5853", "ConditionBrowseLeafName"=>"Charcot-Marie-Tooth Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18092", "ConditionBrowseLeafName"=>"Hereditary Sensory and Motor Neuropathy", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17685", "ConditionBrowseLeafName"=>"Wounds and Injuries", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M14930", "ConditionBrowseLeafName"=>"Cumulative Trauma Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M15974", "ConditionBrowseLeafName"=>"Sprains and Strains", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1081", "ConditionBrowseLeafName"=>"Charcot-Marie-Tooth Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T2761", "ConditionBrowseLeafName"=>"Hereditary Motor and Sensory Neuropathy", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T2766", "ConditionBrowseLeafName"=>"Hereditary Neuropathy With Liability to Pressure Palsies", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T5067", "ConditionBrowseLeafName"=>"Roussy Levy Syndrome", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"Wounds and Injuries", "ConditionBrowseBranchAbbrev"=>"BC26"}, {"ConditionBrowseBranchName"=>"Diseases and Abnormalities at or Before Birth", "ConditionBrowseBranchAbbrev"=>"BC16"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"144"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"May 1999"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"June 2000", "CompletionDateStruct"=>{"CompletionDate"=>"January 2002"}, "LastUpdateSubmitDate"=>"May 14, 2013", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"May 15, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Carpal tunnel syndrome", "Acupuncture", "Median nerve", "Single-blind mute methodology"]}, "ConditionList"=>{"Condition"=>["Carpal Tunnel Syndrome"]}}, "DescriptionModule"=>{"BriefSummary"=>"This study will look at the effectiveness of acupuncture for treating carpal tunnel syndrome (CTS). People who participate in this study will have CTS that has been diagnosed by physical examination and neurological testing. We will randomly assign study participants to receive one of the three types of acupuncture either once, twice, or three times weekly for a total of 6 weeks. Acupuncturists will treat one group of patients with true acupuncture. They will give the other two groups of patients one of two alternative acupuncture treatments that do not use the true acupuncture points. The patients and evaluators will not know the type of acupuncture (True, Alternative 1, or Alternative 2) that is being used. The acupuncturists will not communicate with the patients and will not be involved in patient evaluation.", "DetailedDescription"=>"This is a randomized, double-blind, controlled trial of acupuncture for carpal tunnel syndrome (CTS). The study's aims are: (1) To show that we can develop a \"single-blind mute\" methodology that will enable true and alternative acupuncture to be given in a standardized and unbiased fashion. (2) To identify and standardize the most appropriate invasive control (alternative) acupuncture points for CTS. (3) To develop a manual of acupuncture methods that codifies the techniques of administration of true and alternative points that can be used at any site performing a randomized clinical trial for CTS. (4) To demonstrate that patient recruitment for and retention in a small, short-term, randomized controlled trial (RCT) of acupuncture for CTS is sufficient to justify a full-scale RCT. (5) To determine, in an RCT, whether true acupuncture provides meaningful benefit for pain in CTS compared to alternative acupuncture and whether the frequency of administration of acupuncture influences the outcome.\n\nThe patients and evaluators will be blinded as to the type of acupuncture (True, Alternative 1, or Alternative 2). The acupuncturists will not be blinded but will be mute (noncommunicative to the patients) and will not be involved in patient evaluation. Patients will have clinically and electrodiagnostically proven CTS. They will be randomized to receive one of the three types of acupuncture either once, twice, or three times weekly for 6 weeks total (three by three design). Our aim is to recruit 144 patients for this study. The primary outcome measure will be a validated CTS Symptom Severity Scale at 2 weeks after the last acupuncture treatment. We will evaluate patients 10 weeks later to determine the durability of any improvement from acupuncture. Other outcome measures include subjective symptoms, functional status, analgesic consumption, frequency/duration of splinting, and effect on median nerve conduction velocity."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"70 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nHand or wrist pain combined with parathesias or numbness in any or all fingers, predominating in a median nerve distribution, and especially occurring at night\nSymptoms unresponsive or poorly responsive to standard conservative therapy (wrist splints, analgesics, nonsteroidal anti-inflammatory drugs)\nElectrodiagnostic evidence of distal median neuropathy compatible with carpal tunnel syndrome (to be confirmed at study site)\nSymptoms present for at least 3 months\nNo prior treatment with acupuncture for carpal tunnel syndrome\n\nExclusion Criteria:\n\nEvidence of pronounced abductor pollicis weakness or significant thenar wasting (probable candidate for carpal tunnel surgery)\nPrior carpal tunnel surgery on affected side\nUse of narcotic analgesia\nHistory of wrist or hand fracture on the symptomatic limb\nCurrent pregnancy or less than 3 months postpartum\nCorticosteroid injection into the carpal tunnel within 3 months\nHistory of generalized peripheral neuropathy or clinical or electrodiagnostic evidence of generalized polyneuropathy or mononeuropathy multiplex\nHistory of other neurologic disorders which may cause confusion with the diagnosis of carpal tunnel syndrome, including but not limited to stroke, cervical radiculopathy, myelopathy, subdural hematoma, brain tumor\nInflammatory articular disease or tendinitis of the hand or wrist by history or physical examination\nInsulin-dependent diabetes mellitus\nClinical hypothyroidism\nChronic renal failure or renal dialysis or forearm fistulae\nOther disorder known to predispose to carpal tunnel syndrome including acromegaly, multiple myeloma, amyloidosis"}, "IdentificationModule"=>{"NCTId"=>"NCT00000394", "BriefTitle"=>"Acupuncture for Carpal Tunnel Syndrome", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"George Washington University"}, "OfficialTitle"=>"A Controlled Trial of Acupuncture for Carpal Tunnel Syndrome", "OrgStudyIdInfo"=>{"OrgStudyId"=>"R01AR045894", "OrgStudyIdLink"=>"https://reporter.nih.gov/quickSearch/R01AR045894", "OrgStudyIdType"=>"U.S. NIH Grant/Contract"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01AR045894", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01AR045894", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"NIAMS-003"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Acupuncture therapy", "InterventionType"=>"Procedure"}]}}, "ContactsLocationsModule"=>{"OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Arthur Weinstein, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"The George Washington University Medical Center"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"George Washington University", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)", "CollaboratorClass"=>"NIH"}]}}}}}}
