Nctid:
NCT06227078
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010003", "term"=>"Osteoarthritis"}], "ancestors"=>[{"id"=>"D000001168", "term"=>"Arthritis"}, {"id"=>"D000007592", "term"=>"Joint Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000012216", "term"=>"Rheumatic Diseases"}], "browseLeaves"=>[{"id"=>"M12926", "name"=>"Osteoarthritis", "asFound"=>"Osteoarthritis", "relevance"=>"HIGH"}, {"id"=>"M22168", "name"=>"Osteoarthritis, Knee", "relevance"=>"LOW"}, {"id"=>"M22785", "name"=>"Lacerations", "relevance"=>"LOW"}, {"id"=>"M15241", "name"=>"Rupture", "relevance"=>"LOW"}, {"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>56}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2021-09-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-08-30", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-25", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-08-30", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Pain intensity - Visual analog scale", "timeFrame"=>"Baseline", "description"=>"The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled \"No Pain\" or \"No Symptoms,\" and the other end labeled \"Worst Pain Imaginable\" or \"Maximum Symptoms.\""}, {"measure"=>"Pain intensity - Visual analog scale", "timeFrame"=>"8 weeks", "description"=>"The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled \"No Pain\" or \"No Symptoms,\" and the other end labeled \"Worst Pain Imaginable\" or \"Maximum Symptoms.\""}, {"measure"=>"Pain intensity - Visual analog scale", "timeFrame"=>"6 months", "description"=>"The VAS is usually presented as a straight line, often 10 centimeters (or another standard length), with two endpoints representing extreme points on a continuum. For example, one end may be labeled \"No Pain\" or \"No Symptoms,\" and the other end labeled \"Worst Pain Imaginable\" or \"Maximum Symptoms.\""}], "secondaryOutcomes"=>[{"measure"=>"Functional disability - WOMAC", "timeFrame"=>"Baseline", "description"=>"The WOMAC scale consists of three subscales, each assessing a different dimension of health related to osteoarthritis."}, {"measure"=>"Functional disability - WOMAC", "timeFrame"=>"8 weeks", "description"=>"The WOMAC scale consists of three subscales, each assessing a different dimension of health related to osteoarthritis."}, {"measure"=>"Functional disability - WOMAC", "timeFrame"=>"6 months", "description"=>"The WOMAC scale consists of three subscales, each assessing a different dimension of health related to osteoarthritis."}, {"measure"=>"Sports performance - Timed up and go test", "timeFrame"=>"Baseline", "description"=>"Ask the individual to sit in the chair with their back against the backrest and their arms on the chair arms (if available). On the \"go\" signal, instruct them to stand up, walk around the first cone, return to the chair, and sit back down. Use a stopwatch to measure the time it takes for the individual to complete the task. Faster times generally indicate better agility and functional mobility."}, {"measure"=>"Sports performance - Timed up and go test", "timeFrame"=>"8 weeks", "description"=>"Ask the individual to sit in the chair with their back against the backrest and their arms on the chair arms (if available). On the \"go\" signal, instruct them to stand up, walk around the first cone, return to the chair, and sit back down. Use a stopwatch to measure the time it takes for the individual to complete the task. Faster times generally indicate better agility and functional mobility."}, {"measure"=>"Sports performance - Timed up and go test", "timeFrame"=>"6 months", "description"=>"Ask the individual to sit in the chair with their back against the backrest and their arms on the chair arms (if available). On the \"go\" signal, instruct them to stand up, walk around the first cone, return to the chair, and sit back down. Use a stopwatch to measure the time it takes for the individual to complete the task. Faster times generally indicate better agility and functional mobility."}, {"measure"=>"Sports performance - 40 Metre zig zag test", "timeFrame"=>"Baseline", "description"=>"Set up a zigzagging path using cones or markers. The path should be 40 meters in total length. The zigzag pattern should include sharp turns, requiring participants to change direction quickly. Explain the test to the participant, emphasizing the need to navigate through the zigzag path as quickly as possible.\n\nEmphasize the importance of agility, speed, and quick changes in direction. Use a stopwatch or timer to measure the time it takes for the participant to complete the 40-meter zigzag course. On the \"go\" signal, the participant should start from the beginning and navigate through the zigzag path as quickly as possible.\n\nTime should be recorded when the participant crosses the finishing line."}, {"measure"=>"Sports performance - 40 Metre zig zag test", "timeFrame"=>"8 weeks", "description"=>"Set up a zigzagging path using cones or markers. The path should be 40 meters in total length. The zigzag pattern should include sharp turns, requiring participants to change direction quickly. Explain the test to the participant, emphasizing the need to navigate through the zigzag path as quickly as possible.\n\nEmphasize the importance of agility, speed, and quick changes in direction. Use a stopwatch or timer to measure the time it takes for the participant to complete the 40-meter zigzag course. On the \"go\" signal, the participant should start from the beginning and navigate through the zigzag path as quickly as possible.\n\nTime should be recorded when the participant crosses the finishing line."}, {"measure"=>"Sports performance - 40 Metre zig zag test", "timeFrame"=>"6 months", "description"=>"Set up a zigzagging path using cones or markers. The path should be 40 meters in total length. The zigzag pattern should include sharp turns, requiring participants to change direction quickly. Explain the test to the participant, emphasizing the need to navigate through the zigzag path as quickly as possible.\n\nEmphasize the importance of agility, speed, and quick changes in direction. Use a stopwatch or timer to measure the time it takes for the participant to complete the 40-meter zigzag course. On the \"go\" signal, the participant should start from the beginning and navigate through the zigzag path as quickly as possible.\n\nTime should be recorded when the participant crosses the finishing line."}, {"measure"=>"Quality of life - SF-12", "timeFrame"=>"Baseline", "description"=>"The Short Form Health Survey (SF-12) is a widely used and validated questionnaire designed to assess health-related quality of life (HRQoL) across various populations. It is a shorter version of the SF-36 and provides a quick and reliable measure of general health status. The SF-12 includes 12 questions covering eight health domains and yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS)."}, {"measure"=>"Quality of life - SF-12", "timeFrame"=>"8 weeks", "description"=>"The Short Form Health Survey (SF-12) is a widely used and validated questionnaire designed to assess health-related quality of life (HRQoL) across various populations. It is a shorter version of the SF-36 and provides a quick and reliable measure of general health status. The SF-12 includes 12 questions covering eight health domains and yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS)."}, {"measure"=>"Quality of life - SF-12", "timeFrame"=>"6 months", "description"=>"The Short Form Health Survey (SF-12) is a widely used and validated questionnaire designed to assess health-related quality of life (HRQoL) across various populations. It is a shorter version of the SF-36 and provides a quick and reliable measure of general health status. The SF-12 includes 12 questions covering eight health domains and yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS)."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Knee Osteoarthritis", "Meniscus Tear"]}, "descriptionModule"=>{"briefSummary"=>"Degenerative meniscal tears are a common cause of osteoarthritis commonly diagnosed in football players and are considered a major risk factor for the development of knee osteoarthritis. This study aimed to investigate the Clinical and functional effects of kinesiotaping and physiotherapy in grade 2 osteoarthritis following degenerative meniscal tears in football players.", "detailedDescription"=>"Degenerative meniscal tears represent a prevalent issue among football players and are frequently associated with an increased risk of developing knee osteoarthritis. This study seeks to explore the clinical and functional impacts of employing kinesiotaping and physiotherapy as interventions in grade 2 osteoarthritis resulting from degenerative meniscal tears in football players.\n\nKinesiotaping is a therapeutic technique involving the application of specialized elastic tapes to targeted areas, aiming to support injured muscles and joints, enhance circulation, and alleviate pain. Physiotherapy, on the other hand, employs a range of exercises and modalities to promote healing and improve joint function. Both modalities are commonly used in sports medicine to manage musculoskeletal injuries.\n\nThe investigation focuses on football players diagnosed with grade 2 osteoarthritis secondary to degenerative meniscal tears. Grade 2 osteoarthritis signifies moderate cartilage loss and potential joint instability. The participants will be divided into two groups: one receiving kinesiotaping in combination with physiotherapy and the other undergoing conventional physiotherapy alone.\n\nClinical assessments will include pain levels, joint swelling, and range of motion. Functional outcomes such as strength, agility, and proprioception will be measured through standardized tests. The study's duration and follow-up periods will allow for a comprehensive evaluation of both short-term and long-term effects.\n\nThe hypothesis underlying this research posits that the combined approach of kinesiotaping and physiotherapy will yield superior outcomes compared to traditional physiotherapy alone. Potential benefits may include reduced pain, improved joint stability, enhanced functional capacity, and a decreased risk of further degeneration.\n\nBy shedding light on the efficacy of these interventions, this study aspires to contribute valuable insights to the field of sports medicine, aiding in the development of evidence-based strategies for managing degenerative meniscal tears and mitigating the risk of osteoarthritis in football players. The findings could inform clinical practice and potentially influence rehabilitation protocols for athletes facing similar challenges."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"35 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nDiagnosis of Knee Osteoarthritis:\n\nIndividuals with a confirmed diagnosis of knee osteoarthritis based on clinical and/or radiological assessments.\n\nMild to Moderate Knee OA:\n\nKinesiotaping may be more appropriate for individuals with mild to moderate knee OA rather than severe cases.\n\nPresence of Pain and Discomfort:\n\nIndividuals experiencing pain, discomfort, or limitations in function related to knee osteoarthritis.\n\nFunctional Limitations:\n\nThose with functional limitations in activities of daily living or reduced mobility due to knee OA.\n\nNo Contraindications:\n\nIndividuals without contraindications to kinesiotaping, such as skin allergies, infections, or open wounds in the application area.\n\nWillingness to Participate:\n\nIndividuals who are willing to participate in and adhere to the kinesiotaping intervention.\n\nNot Responsive to Other Conservative Treatments:\n\nThose who have tried and not responded adequately to other conservative treatments for knee OA, such as exercise, physical therapy, or oral medications.\n\nAbsence of Serious Comorbidities:\n\nIndividuals without serious comorbidities or medical conditions that may contraindicate the use of kinesiotaping.\n\nIndividual Preferences:\n\nConsideration of individual preferences and acceptance of kinesiotaping as part of the treatment plan.\n\nExclusion Criteria:\n\n* 1. Skin Conditions:\n\n * Active skin infections, allergies, or open wounds in the area where kinesiotape is to be applied.\n * Skin conditions that may be aggravated or worsened by the adhesive in the tape. 2. Vascular Disorders:\n * Conditions that affect blood circulation, such as peripheral vascular disease, deep vein thrombosis, or other vascular disorders, which may be worsened by the application of kinesiotape.\n\n 3. Peripheral Neuropathy:\n * Individuals with peripheral neuropathy or other nerve disorders, as kinesiotaping may affect sensation, and there is a risk of injury or discomfort.\n\n 4. Cancer or Tumors:\n * Active cancer or tumors in the region where kinesiotape is to be applied, as kinesiotaping could interfere with cancer treatment or exacerbate symptoms.\n\n 5. Joint Instability:\n * Individuals with severe joint instability, as kinesiotape may not provide sufficient support for highly unstable joints.\n\n 6. Allergies to Tape Components:\n * Known allergies to the materials or adhesive used in kinesiotape. 7. Circulatory Disorders:\n * Severe circulatory disorders, which may be exacerbated by the pressure or tension applied by kinesiotape."}, "identificationModule"=>{"nctId"=>"NCT06227078", "briefTitle"=>"Effects of Kinesiotaping and Physiotherapy in Grade 2 Osteoarthritis Following Degenerative Meniscal Tears", "organization"=>{"class"=>"OTHER", "fullName"=>"Prince Sattam Bin Abdulaziz University"}, "officialTitle"=>"Clinical and Functional Effects of Kinesiotaping and Physiotherapy in Grade 2 Osteoarthritis Following Degenerative Meniscal Tears in Football Players - A Randomized Control Trial", "orgStudyIdInfo"=>{"id"=>"RHPT/021/093"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Active Kinesiotaping + Physiotherapy", "description"=>"The application of kinesiotaping for grade 2 osteoarthritis involves the application of an anchor strip at one end of the affected joint, typically with no stretch. Apply the kinesiotape with the desired amount of stretch, usually around 50-80% of its maximum stretch capacity. Direct the tape along the muscle or joint in a specific pattern, such as \"I,\" \"Y,\" or \"X\" depending on the therapeutic goal. Finish with an anchor strip at the opposite end, with no stretch to secure the tape in place.\n\nPhysiotherapy:\n\nApply TENS: Low-frequency TENS (2-10 Hz) that produces a tingling or buzzing sensation without causing discomfort or pain. TENS sessions may last between 20 to 30 minutes per session.\n\nStrengthening exercises:\n\n1. Quadriceps Sets:\n2. Straight Leg Raises:\n3. Seated Leg Press:\n4. Hamstring Curls:\n5. Calf Raises:\n\n * Repeat the exercises for 10 times, 3 sets in a session for 8 weeks.", "interventionNames"=>["Device: Kinesiotaping"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo Kinesiotaping + Physiotherapy", "description"=>"The application of kinesiotaping for grade 2 osteoarthritis involves the application of an anchor strip at one end of the affected joint, typically with no stretch. Apply the kinesiotape without stretch, Direct the tape along the muscle or joint in a specific pattern, such as \"I,\" \"Y,\" or \"X\" depending on the therapeutic goal. Finish with an anchor strip at the opposite end, with no stretch to secure the tape in place.\n\nPhysiotherapy:\n\nApply TENS: Low-frequency TENS (2-10 Hz) that produces a tingling or buzzing sensation without causing discomfort or pain. TENS sessions may last between 20 to 30 minutes per session.\n\nStrengthening exercises:\n\n1. Quadriceps Sets:\n2. Straight Leg Raises:\n3. Seated Leg Press:\n4. Hamstring Curls:\n5. Calf Raises:\n\n * Repeat the exercises for 10 times, 3 sets in a session for 8 weeks.", "interventionNames"=>["Device: Kinesiotaping"]}], "interventions"=>[{"name"=>"Kinesiotaping", "type"=>"DEVICE", "description"=>"Kinesiotaping is commonly used in sports medicine and rehabilitation settings. It is applied by trained professionals, such as physiotherapists or athletic trainers, who are skilled in assessing individual needs and determining the appropriate taping technique for specific conditions. The tape is typically worn for several days, allowing for continuous therapeutic effects.\n\nIt's important to note that while kinesiotaping has gained popularity, its effectiveness is still a subject of ongoing research, and its application should be part of a comprehensive treatment plan. Individual responses to kinesiotape may vary, and its use is often combined with other therapeutic interventions for optimal results.", "armGroupLabels"=>["Active Kinesiotaping + Physiotherapy", "Placebo Kinesiotaping + Physiotherapy"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"11942", "city"=>"Al Kharj", "state"=>"Riyad", "country"=>"Saudi Arabia", "facility"=>"Saud Alrawilli", "geoPoint"=>{"lat"=>24.15541, "lon"=>47.33457}}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["SAP"], "timeFrame"=>"2 months", "ipdSharing"=>"YES"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Gopal Nambi", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Gopal Nambi", "investigatorFullName"=>"Gopal Nambi", "investigatorAffiliation"=>"Prince Sattam Bin Abdulaziz University"}}}}
