Nctid:
NCT06611332
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000007405", "term"=>"Intervertebral Disc Displacement"}, {"id"=>"D000011843", "term"=>"Radiculopathy"}, {"id"=>"D000006547", "term"=>"Hernia"}], "ancestors"=>[{"id"=>"D000010523", "term"=>"Peripheral Nervous System Diseases"}, {"id"=>"D000009468", "term"=>"Neuromuscular Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000020763", "term"=>"Pathological Conditions, Anatomical"}, {"id"=>"D000013122", "term"=>"Spinal Diseases"}, {"id"=>"D000001847", "term"=>"Bone Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}], "browseLeaves"=>[{"id"=>"M10439", "name"=>"Intervertebral Disc Displacement", "asFound"=>"Disc Herniation", "relevance"=>"HIGH"}, {"id"=>"M14689", "name"=>"Radiculopathy", "asFound"=>"Radiculopathy", "relevance"=>"HIGH"}, {"id"=>"M9625", "name"=>"Hernia", "asFound"=>"Herniation", "relevance"=>"HIGH"}, {"id"=>"M13432", "name"=>"Peripheral Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12411", "name"=>"Neuromuscular Diseases", "relevance"=>"LOW"}, {"id"=>"M22519", "name"=>"Pathological Conditions, Anatomical", "relevance"=>"LOW"}, {"id"=>"M15919", "name"=>"Spinal Diseases", "relevance"=>"LOW"}, {"id"=>"M5126", "name"=>"Bone Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>170}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-15", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-10-25", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-10-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Proportion of responders", "timeFrame"=>"Weeks 8 and 24", "description"=>"Definition of a response: a reduction of at least 2 points in the score of the Numerical Rating Scale for both low back pain and leg pain."}], "secondaryOutcomes"=>[{"measure"=>"Intensity of low back pain", "timeFrame"=>"Weeks 2, 4, 8, 16, and 24", "description"=>"Changes from baseline in the intensity of low back pain assessed by the Numerical Rating Scale"}, {"measure"=>"Intensity of leg pain", "timeFrame"=>"Weeks 2, 4, 8, 16, and 24", "description"=>"Changes from baseline in intensity of leg pain assessed by the Numerical Rating Scale"}, {"measure"=>"Level of disability", "timeFrame"=>"Weeks 2, 4, 8, 16, and 24", "description"=>"Changes from baseline in the level of disability assessed by the Roland-Morris Disability Questionnaire"}, {"measure"=>"Performance status", "timeFrame"=>"Weeks 2, 4, 8, 16, and 24", "description"=>"Changes from baseline in functional status assessed by the Japanese Orthopaedic Association Score"}, {"measure"=>"Severity of depression", "timeFrame"=>"Weeks 2, 4, 8, 16, and 24", "description"=>"Changes from baseline in the severity of depression assessed by the Hamilton Depression Rating Scale"}, {"measure"=>"Severity of anxiety", "timeFrame"=>"Weeks 2, 4, 8, 16, and 24", "description"=>"Changes from baseline in the severity of anxiety assessed by the Hamilton Anxiety Rating Scale"}, {"measure"=>"Sleep quality", "timeFrame"=>"Weeks 2, 4, 8, 16, and 24", "description"=>"Changes from baseline in sleep quality assessed by the Insomnia Severity Index"}, {"measure"=>"Pain self-efficacy", "timeFrame"=>"Weeks 2, 4, 8, 16, and 24", "description"=>"Changes from baseline in pain self-efficacy assessed by the Pain self-efficacy questionnaire"}, {"measure"=>"Use of analgesics", "timeFrame"=>"Weeks 8 and 24", "description"=>"The proportion of patients who used analgesics for emergency."}, {"measure"=>"Incidence of lumbar spine surgery", "timeFrame"=>"Weeks 8 and 24", "description"=>"The incidence of lumbar spine surgery during the follow-up"}, {"measure"=>"Incidence of any adverse events", "timeFrame"=>"Weeks 8 and 24", "description"=>"Adverse events be reported by patients and determined by clinicians."}, {"measure"=>"Incidence of treatment-related adverse events", "timeFrame"=>"Weeks 8 and 24", "description"=>"Treatment-related adverse events include adverse events caused by electroacupuncture or sham electroacupuncture treatment."}, {"measure"=>"Incidence of serious adverse event", "timeFrame"=>"Weeks 8 and 24", "description"=>"Serious adverse events refer to adverse events that require hospitalization or an extended hospital stay, result in disability, pose a threat to life, or cause death."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["electroacupuncture", "radiculopathy", "sham control", "randomized controlled trial", "lumbar disc herniation"], "conditions"=>["Lumbar Disc Herniation", "Radiculopathy Lumbar"]}, "descriptionModule"=>{"briefSummary"=>"Lumbar disc herniation with radiculopathy (LDHR) is the local displacement of the intervertebral disc and its contents beyond the edge of the normal intervertebral disc space, resulting in pain, weakness or numbness in the muscle or dermatomal distribution area. Electroacupuncture is based on obtaining the needling sensation manually and applying electrical stimulation of different frequencies and intensities, aiming to enhance the intensity of acupoint stimulation to improve the effect. As a kind of acupoint stimulation therapy, electroacupuncture has shown analgesic effects in animal experiments. However, at present, the clinical evidence of electroacupuncture applied in the treatment of LDHR is still insufficient. Therefore, this randomized, single-blind, sham electroacupuncture controlled trial aims to evaluate the efficacy and safety of electroacupuncture as a treatment for LDHR."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Aged from 18 to 70 years old.\n2. With intervertebral disc protrusion confirmed by a MRI or CT, accompanied by radicular pain in the lower extremities.\n3. With a NRS score ≥ 4 points for both low back pain and leg pain, and the pain lasts for at least 3 months;\n4. Voluntarily participating the trial and signing the informed consent form.\n\nExclusion Criteria:\n\n1. Previous surgical treatment of the spine.\n2. Received any physical therapy for lumbar disc herniation within the recent 3 months.\n3. Complicated with diseases that can cause low back and leg pain.\n4. Symptomatic foraminal stenosis caused by severe degenerative diseases, accompanied by severe nerve injuries.\n5. Previous severe mental illness, organ failure, or malignant tumor.\n6. Planned spinal surgery or other major surgeries within the next 3 months.\n7. Pregnancy or lactation."}, "identificationModule"=>{"nctId"=>"NCT06611332", "briefTitle"=>"Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy", "organization"=>{"class"=>"OTHER", "fullName"=>"Jiangxi University of Traditional Chinese Medicine"}, "officialTitle"=>"Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy: a Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"JXUCM-ACU-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Electroacupuncture", "interventionNames"=>["Other: Electroacupuncture"]}, {"type"=>"SHAM_COMPARATOR", "label"=>"Sham electroacupuncture", "interventionNames"=>["Other: Sham electroacupuncture"]}], "interventions"=>[{"name"=>"Electroacupuncture", "type"=>"OTHER", "description"=>"The main acupoints selected for the electroacupuncture group are bilateral BL23, bilateral BL25, bilateral GB30, bilateral LR11, bilateral LR8, GV4, GV3, and the affected BL40, and the secondary acupoints selected are bilateral BL54, the affected side BL57 and the affected side BL60.The treatment will be administered once every other day for 30 minutes each time, lasting for 8 consecutive weeks, totaling 24 sessions.", "armGroupLabels"=>["Electroacupuncture"]}, {"name"=>"Sham electroacupuncture", "type"=>"OTHER", "description"=>"In the sham electroacupuncture group, the acupoints will be at a position 2 cm lateral to the correct acupoints horizontally. The dosage and treatment course are the same as those in the electroacupuncture group.", "armGroupLabels"=>["Sham electroacupuncture"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"330006", "city"=>"Jiangxi", "state"=>"Nanchang", "country"=>"China", "contacts"=>[{"name"=>"Xu Zhou Professor, M.D.", "role"=>"CONTACT", "email"=>"88299077@qq.com", "phone"=>"+86-0791-86363831"}], "facility"=>"The Affiliated Hospital of Jiangxi University of Chinese Medicine"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Jiangxi University of Traditional Chinese Medicine", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Xu Zhou", "investigatorAffiliation"=>"Jiangxi University of Traditional Chinese Medicine"}}}}
