Nctid:
NCT06616792
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000096825", "term"=>"Rhinosinusitis"}, {"id"=>"D012852", "term"=>"Sinusitis"}], "ancestors"=>[{"id"=>"D012220", "term"=>"Rhinitis"}, {"id"=>"D012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D010254", "term"=>"Paranasal Sinus Diseases"}, {"id"=>"D009668", "term"=>"Nose Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D010038", "term"=>"Otorhinolaryngologic Diseases"}], "browseLeaves"=>[{"id"=>"M3269", "name"=>"Rhinosinusitis", "asFound"=>"Rhinosinusitis", "relevance"=>"HIGH"}, {"id"=>"M15657", "name"=>"Sinusitis", "asFound"=>"Rhinosinusitis", "relevance"=>"HIGH"}, {"id"=>"M15049", "name"=>"Rhinitis", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}, {"id"=>"M13167", "name"=>"Paranasal Sinus Diseases", "relevance"=>"LOW"}, {"id"=>"M12604", "name"=>"Nose Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M12961", "name"=>"Otorhinolaryngologic Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "asFound"=>"Chronic", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D003907", "term"=>"Dexamethasone"}], "ancestors"=>[{"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D000932", "term"=>"Antiemetics"}, {"id"=>"D001337", "term"=>"Autonomic Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D005938", "term"=>"Glucocorticoids"}, {"id"=>"D006728", "term"=>"Hormones"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M7102", "name"=>"Dexamethasone", "asFound"=>"High", "relevance"=>"HIGH"}, {"id"=>"M235549", "name"=>"Dexamethasone acetate", "relevance"=>"LOW"}, {"id"=>"M199152", "name"=>"BB 1101", "relevance"=>"LOW"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4251", "name"=>"Antiemetics", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>90}}, "statusModule"=>{"overallStatus"=>"ENROLLING_BY_INVITATION", "startDateStruct"=>{"date"=>"2024-07-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-06", "completionDateStruct"=>{"date"=>"2025-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Sino nasal Outcome Test 22 (SNOT-22)", "timeFrame"=>"one month", "description"=>"This is a Quality Of Life Questionnaire specifically designed for sinusitis patient. It consists of 22 item sinus specific question which has to be administered to the patient and the total sum of all the items will be recorded based on the severity of the patient's condition and the scores will be calculated"}, {"measure"=>"Computerized Tomography Scan", "timeFrame"=>"one month", "description"=>"CT scan will be used for assessment of mucosal thickening of maxillary sinuses, which is based on 0-3 system: 0 = clear, 1= mild or moderate mucosal thickening, 2 = severe mucosal thickening, 3 = total opacification"}]}, "oversightModule"=>{"isUsExport"=>true, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["Dexamethasone Phonophoresis, Laser Acupuncture, Chronic Rhinosinusitis"], "conditions"=>["Chronic Rhinosinusitis (CRS)"]}, "referencesModule"=>{"references"=>[{"pmid"=>"34423908", "type"=>"BACKGROUND", "citation"=>"da Silva GS, Dos Santos Isoppo K. Therapeutic ultrasound as a treatment for chronic rhinosinusitis: A systematic review. Clin Respir J. 2021 Dec;15(12):1275-1285. doi: 10.1111/crj.13441. Epub 2021 Aug 29."}, {"pmid"=>"36091598", "type"=>"BACKGROUND", "citation"=>"Lee B, Kwon CY, Park MY. Acupuncture for the Treatment of Chronic Rhinosinusitis: A PRISMA-Compliant Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2022 Aug 31;2022:6429836. doi: 10.1155/2022/6429836. eCollection 2022."}, {"pmid"=>"36538169", "type"=>"BACKGROUND", "citation"=>"Naghdi S, Ansari NN, Varedi M, Fathali M, Zarrin M, Kashi-Alashti M, HasanNia F. Use of low-level laser therapy for patients with chronic rhinosinusitis: a single-blind, sham-controlled clinical trial. Lasers Med Sci. 2022 Dec 20;38(1):5. doi: 10.1007/s10103-022-03684-z."}]}, "descriptionModule"=>{"briefSummary"=>"This study is designed to provide a comprehensive overview of evidence concerning the efficacy and safety of dexamethasone phonophoresis and laser acupuncture for treatment of chronic rhinosinusitis."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"50 years", "minimumAge"=>"30 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age range between 30 to 50 years.\n* Male and female patients will participate in the study.\n* All patients have chronic rhinosinusitis, who are experiencing 12 weeks or longer of 2 or more of the following signs and symptoms:\n\nmucopurulent drainage (anterior, posterior, or both) nasal obstruction (congestion) facial pain-pressure-fullness, or decreased sense of smell\n\n• All patients enrolled in the study will have their informed consent.\n\nExclusion Criteria:\n\n* Patients with metal implants (pacemakers, dental implants, or any other implants).\n* Patients with cancer, pregnancy or impaired vascular circulation.\n* Patients who suffer from mental or psychological disorders.\n* Patients with any systemic diseases that may interfere with the objectives of the study.\n* Patients with long-term use of corticosteroids or immunosuppressive agents.\n* Congenital defects on face and nose.\n* Fracture of nose or face.\n* Patients who are contraindicated for corticosteroids use in patient who will receive dexamethasone phonophoresis.\n* Allergic patients.\n* Pervious nasal surgery.\n* Patients with nasal septum deviation.\n* patients who had used antihistamines within 1 week, topical corticosteroids within2 weeks, systemic corticosteroids within 4 weeks, anti-cholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, non-steroidal analgesics within 2 weeks or any medication that may interfere with the objectives of the study."}, "identificationModule"=>{"nctId"=>"NCT06616792", "briefTitle"=>"Dexamethasone Phonophoresis Versus Laser Acupuncture on Chronic Rhinosinusitis", "organization"=>{"class"=>"OTHER", "fullName"=>"Cairo University"}, "officialTitle"=>"Dexamethasone Phonophoresis Versus Laser Acupuncture on Chronic Rhinosinusitis", "orgStudyIdInfo"=>{"id"=>"P.T.REC/012/005254"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Group (A)", "description"=>"Each participant in this group will receive dexamethasone phonophoresis, US with the use of 0.4% Dexamethasone sodium phosphate gel for phonophoresis. over maxillary and frontal sinuses for 3 sessions per week for one month, in addition to the traditional medication.", "interventionNames"=>["Combination Product: Dexamethasone phonophoresis", "Other: Traditional medication"]}, {"type"=>"EXPERIMENTAL", "label"=>"Group (B)", "description"=>"Each participant in this group will receive low level laser placed in contact with the skin perpendicular over the body acupoints (LI 4) - (LI 20) - (EX- HN5) - (GV 20) - (GV 24) - (ST3) - (ST 7) in both sides and on (EX-HN3) acupoint, with a duration of 90 sec for each point three times per week for a month., in addition to the traditional medication.", "interventionNames"=>["Device: Laser Acupuncture", "Other: Traditional medication"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group (C)", "description"=>"Each participant in this group will receive the traditional medication only.", "interventionNames"=>["Other: Traditional medication"]}], "interventions"=>[{"name"=>"Dexamethasone phonophoresis", "type"=>"COMBINATION_PRODUCT", "description"=>"Ultrasound therapeutic device with the use of 0.4% Dexamethasone sodium phosphate gel for phonophoresis.", "armGroupLabels"=>["Group (A)"]}, {"name"=>"Laser Acupuncture", "type"=>"DEVICE", "description"=>"low level laser therapy placed in contact with the skin perpendicular over the body acupoints (LI 4) - (LI 20) - (EX- HN5) - (GV 20) - (GV 24) - (ST3) - (ST 7) in both sides and on (EX-HN3) acupoint,", "armGroupLabels"=>["Group (B)"]}, {"name"=>"Traditional medication", "type"=>"OTHER", "description"=>"Each participant in this group receive the traditional medication.", "armGroupLabels"=>["Group (A)", "Group (B)", "Group (C)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"12611", "city"=>"Dokki", "state"=>"Giza", "country"=>"Egypt", "facility"=>"Faculty of Physical therapy, Cairo University", "geoPoint"=>{"lat"=>30.03823, "lon"=>31.2113}}], "overallOfficials"=>[{"name"=>"Walaa Abd Elaziem Abd Elaziz Walaa Abd Elaziem Abd Elaziz, Doctoral degree", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Cairo University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "description"=>"pre and post assessment measures results of:\n\n1. Sino nasal Outcome Test 22 (SNOT-22)\n2. Computerized Tomography Scan:"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cairo University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Walaa Abd Elaziem Abd Elaziz", "investigatorFullName"=>"Walaa Abd Elaziem Abd Elaziz", "investigatorAffiliation"=>"Cairo University"}}}}
