Nctid:
NCT06611709
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000013716", "term"=>"Tennis Elbow"}], "ancestors"=>[{"id"=>"D000070639", "term"=>"Elbow Tendinopathy"}, {"id"=>"D000052256", "term"=>"Tendinopathy"}, {"id"=>"D000009135", "term"=>"Muscular Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000092464", "term"=>"Elbow Injuries"}, {"id"=>"D000001134", "term"=>"Arm Injuries"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}, {"id"=>"D000013708", "term"=>"Tendon Injuries"}], "browseLeaves"=>[{"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M16486", "name"=>"Tennis Elbow", "asFound"=>"Lateral Epicondylitis", "relevance"=>"HIGH"}, {"id"=>"M27013", "name"=>"Tendinopathy", "relevance"=>"LOW"}, {"id"=>"M627", "name"=>"Elbow Tendinopathy", "relevance"=>"LOW"}, {"id"=>"M12092", "name"=>"Muscular Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M2926", "name"=>"Elbow Injuries", "relevance"=>"LOW"}, {"id"=>"M4444", "name"=>"Arm Injuries", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M16479", "name"=>"Tendon Injuries", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Kinesiotaping vs sham-taping"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>42}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-09-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-20", "studyFirstSubmitDate"=>"2024-09-18", "studyFirstSubmitQcDate"=>"2024-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-08-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Patient-Rated Tennis Elbow Evaluation Questionnaire (PRTEE)", "timeFrame"=>"baseline, week 3, and week 7", "description"=>"0 (best) to 100 (worst)"}, {"measure"=>"VAS pain (0-10)", "timeFrame"=>"baseline, week 3, and week 7", "description"=>"0 no pain; 10 unbearable/max. pain."}], "secondaryOutcomes"=>[{"measure"=>"The Disabilities of the Arm, Shoulder, and Hand (DASH)", "timeFrame"=>"baseline, week 3, and week 7", "description"=>"0 (best condition) to 100 (worst condition)"}, {"measure"=>"grip strength", "timeFrame"=>"baseline, week 3, and week 7", "description"=>"using a Jamar® dynamometer (in kilograms)"}, {"measure"=>"The Short Form-36 (SF-36) quality of life index", "timeFrame"=>"baseline, week 3, and week 7", "description"=>"0, indicating the worst health status, to 100, representing the best possible health"}, {"measure"=>"Patient satisfaction/benefit scale (The Roles and Maudsley score)", "timeFrame"=>"baseline, week 3, and week 7", "description"=>"The Roles and Maudsley score was utilized to evaluate pain and activity limitations in the assessment of treatment efficacy, categorized into four levels: 1 point indicating excellent, 2 points indicating good, 3 points indicating fair, and 4 points indicating poor."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["kinesiotaping", "lateral epicondylitis", "pain", "exercises"], "conditions"=>["Lateral Epicondylitis (tennis Elbow)", "Pain"]}, "descriptionModule"=>{"briefSummary"=>"Lateral epicondylitis significantly impacts daily activities and productivity at work, making it a condition of substantial clinical and socioeconomic importance.Despite its high prevalence, clinical significance, and impact on daily life, the optimal management of LE remains a topic of ongoing debate.\n\nThis study aims to investigate the efficacy of kinesiotaping (KT) on pain intensity, functional status, and quality of life in patients with chronic lateral epicondylitis (LE).\n\nThe study was conducted in the outpatient clinic for level 3 physical medicine and rehabilitation. Patients were randomized into two groups: the real kinesiotaping + home exercise group and the sham taping + home exercise group (randomized by a medical secretary outside the study). A set of widely accepted, literature-consistent primer and seconder outcomes were statistically compared to determine whether one treatment was superior to the other.", "detailedDescription"=>"Between February 1, 2024, and August 31, 2024, a total of 42 patients (17 females, 25 males) with chronic LE were included. Patients were randomized into either the KT or sham-controlled group. Patients were blinded to which group they were assigned to. The taping was performed by the same physician, who was trained and experienced in kinesiotaping.\n\nKinesiotaping and sham-taping were applied six times over three weeks. Both groups received recommendations for activity modification and a home-based stretching and strengthening exercise program. The exercise program was designed by an author who has a national book chapter on exercise for the treatment of lateral epicondylitis, taking into account patient specificity and adherence, and in accordance with the literaturExercise adherence was monitored through weekly outpatient controls (while taping) and by phone check-ins two weeks after the taping was completed.\n\nOutcome measures were visual analog scale (VAS) pain score, Patient-Rated Forearm Evaluation Questionnaire (PRFEQ), grip strength, Disabilities of Arm, Shoulder, and Hand (DASH), quality of life in Short Form-36 (SF-36), and The Roles and Maudsley patient satisfaction score. The subjects were assessed before treatment, at the end of treatment (week three), and four weeks after the end of treatment (week seven).The assessment parameters were also conducted by the same researcher to ensure consistency."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* A pain severity of 4 or higher on the visual analog scale (VAS) during daily activities\n* A history of lateral epicondylitis symptoms lasting at least three months\n\nExclusion Criteria:\n\n* Communication difficulties\n* Significant psychiatric disorders\n* A history of trauma within the past six months\n* Neuromuscular conditions\n* Abnormalities of the upper limb\n* Prior upper limb surgery\n* A history of rheumatic diseases\n* Cervical disc pathology, polyneuropathy, or hand disorders (such as carpal or cubital tunnel syndrome, de Quervain tenosynovitis, osteoarthritis)\n* Receipt of any treatment for lateral epicondylitis (e.g., local injections, physical therapy, splints) within the last six month"}, "identificationModule"=>{"nctId"=>"NCT06611709", "briefTitle"=>"Effectiveness of the Kinesiotaping in the Treatment of Chronic Lateral Epicondylitis", "organization"=>{"class"=>"OTHER_GOV", "fullName"=>"Konya Beyhekim Training and Research Hospital"}, "officialTitle"=>"Effectiveness of the Kinesiotaping in the Treatment of Chronic Lateral Epicondylitis: a Randomized, Sham-controlled, Single-blind Study", "orgStudyIdInfo"=>{"id"=>"KonyaBeyhekimTRH2024"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Kinesiotaping", "description"=>"Kinesiotaping (real) + exercises", "interventionNames"=>["Device: Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex Gold", "Other: exercises"]}, {"type"=>"SHAM_COMPARATOR", "label"=>"Sham-taping", "description"=>"Sham-taping (non-elastic medical cloth tape) + exercises", "interventionNames"=>["Device: sham taping (non-elastic medical cloth tape)", "Other: exercises"]}], "interventions"=>[{"name"=>"sham taping (non-elastic medical cloth tape)", "type"=>"DEVICE", "description"=>"sham taping", "armGroupLabels"=>["Sham-taping"]}, {"name"=>"Kinesiotaping: A standard 5-cm wide KinesioⓇ Tex Gold", "type"=>"DEVICE", "description"=>"A standard 5-cm wide KinesioⓇ Tex Gold", "armGroupLabels"=>["Kinesiotaping"]}, {"name"=>"exercises", "type"=>"OTHER", "description"=>"home-based exercises", "armGroupLabels"=>["Kinesiotaping", "Sham-taping"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"42060", "city"=>"Konya", "state"=>"Selçuklu", "country"=>"Turkey", "facility"=>"Konya Beyhekim Research and Training Hospital, Physical Medicine and Rehabilitation clinics", "geoPoint"=>{"lat"=>37.87135, "lon"=>32.48464}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Konya Beyhekim Training and Research Hospital", "class"=>"OTHER_GOV"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Prof", "investigatorFullName"=>"Ramazan Yılmaz", "investigatorAffiliation"=>"Konya Beyhekim Training and Research Hospital"}}}}
