Nctid:
NCT06231615
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008881", "term"=>"Migraine Disorders"}], "ancestors"=>[{"id"=>"D051270", "term"=>"Headache Disorders, Primary"}, {"id"=>"D020773", "term"=>"Headache Disorders"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M11852", "name"=>"Migraine Disorders", "asFound"=>"Migraine", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M9351", "name"=>"Headache", "relevance"=>"LOW"}, {"id"=>"M22529", "name"=>"Headache Disorders", "relevance"=>"LOW"}, {"id"=>"M26657", "name"=>"Headache Disorders, Primary", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"], "maskingDescription"=>"The evaluation of the patients was carried out by a blinded investigator, and the treatment was carried out by a different investigator."}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"dual parallel group design"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>30}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-10-10", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-09-10", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-26", "studyFirstSubmitDate"=>"2024-01-03", "studyFirstSubmitQcDate"=>"2024-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-08-05", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Heart rate variability", "timeFrame"=>"Change from baseline at 6 weeks treatment program", "description"=>"Heart rate variability is a tool that allows the investigation of cardiovascular autonomic function through the measurement of variations in RR intervals and provides valuable information about the control of the autonomic nervous system"}], "secondaryOutcomes"=>[{"measure"=>"Pain level", "timeFrame"=>"Change from baseline at 6 weeks treatment program", "description"=>"Visual analog scale was used to examine pain levels of participants.Individuals are presented with a line numbered evenly from 1 to 10 and asked to mark the point corresponding to their pain intensity. A higher score indicates that the severity of pain is increasing."}, {"measure"=>"Level of disability due to migraine", "timeFrame"=>"Change from baseline at 6 weeks treatment program", "description"=>"The Migraine Disability Scale was used to evaluate the level of disability due to headache.Patients answer the questions by reflecting on their last 3 months. The total score is examined in 4 stages. 0-5 points means stage 1, 6-10 points means stage 2, 11-20 points means stage 3, 21 points and above means stage 4. 21 points and above means serious disability."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["migraine", "pain", "exercise", "fascia"], "conditions"=>["Migraine"]}, "descriptionModule"=>{"briefSummary"=>"Migraine, which is characterized by attacks and many accompanying symptoms, negatively affects the quality of life of patients. Although different methods have been tried for migraine, there is no definitive treatment approach yet. The aim of this study is to examine the effect of fascia exercises as a new approach on the symptoms and complaints of migraine patients.\n\nThe study was completed with 30 volunteer migraine patients. Participants were divided into two groups in a randomized controlled manner. While head-neck and breathing exercises were applied to the control group, fascial pattern exercises were performed in the study group in addition to these exercises. This protocol was applied 2 days a week for 6 weeks. Pain intensity, quality of life and sleep, heart rate changes, depression and anxiety levels and satisfaction levels were evaluated before and after the treatment.\n\nFascial pattern exercises are an effective approach on the symptoms and complaints of migraine patients and can be adopted as a complementary application in migraine treatment. Since this is the first study in this field, it needs to be supported by other studies in order to increase the provability of the effectiveness of the exercises.", "detailedDescription"=>"Migraine, which is characterized by attacks and many accompanying symptoms, negatively affects the quality of life of patients. Although different methods have been tried for migraine, there is no definitive treatment approach yet. The aim of this study is to examine the effect of fascia exercises as a new approach on the symptoms and complaints of migraine patients.\n\nThe study was completed with 30 volunteer migraine patients. Participants were divided into two groups in a randomized controlled manner. While head-neck and breathing exercises were applied to the control group, fascial pattern exercises were performed in the study group in addition to these exercises. This protocol was applied 2 days a week for 6 weeks. Pain intensity, quality of life and sleep, heart rate changes, depression and anxiety levels and satisfaction levels were evaluated before and after the treatment.\n\nDemographic and descriptive characteristics of the participants were similar (p\\>0.05). In both groups, the number of attacks, duration of attacks, pain intensity, migraine-related disability and anxiety levels decreased and sleep quality improved after treatment (p\\<0.05). There was no significant difference in heart rate change parameters within and between the groups (p\\>0.05). There was no significant difference between the groups in terms of treatment efficacy (p\\>0.05). Patient satisfaction was higher in the fascia exercises group (p\\<0.05).\n\nFascial pattern exercises are an effective approach on the symptoms and complaints of migraine patients and can be adopted as a complementary application in migraine treatment. Since this is the first study in this field, it needs to be supported by other studies in order to increase the provability of the effectiveness of the exercises."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"59 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* having a diagnosis of migraine for at least one year\n* between the ages of 18-65 years,\n* having migraine attacks at least 5 days a month,\n* having a history of migraine starting under the age of 50,\n* giving informed written consent to participate in the study\n\nExclusion Criteria:\n\n* headache due to organic or secondary causes (history of subarachnoid or cerebral hemorrhage, hypertension, cerebral embolism or thrombosis),\n* receiving acupuncture treatment in the last 6 months,\n* history of bleeding diathesis or receiving anticoagulant treatment,\n* being pregnant or lactating,\n* history of malignancy,\n* having a diagnosis of depression or receiving antidepressant treatment,\n* caffeine consumption in the last 4 hours,\n* tobacco use in the last 48 hours,\n* drug and alcohol use in the last week,\n* eating within 2 hours prior to the test,\n* being unable to move independently,\n* having an uncontrolled medical condition,\n* chronic cardiovascular disease,\n* recent surgery,\n* symptoms of somatic dysfunction,\n* musculoskeletal injuries,\n* any medication that interferes with the autonomic nervous system or immune system (e.g., beta blockers, steroids, or TNF-a inhibitors)\n* any medical condition that affects the autonomic nervous system or immune system"}, "identificationModule"=>{"nctId"=>"NCT06231615", "briefTitle"=>"Efficacy of Fascia Exercises in Migraine Patients", "organization"=>{"class"=>"OTHER", "fullName"=>"Ankara Yildirim Beyazıt University"}, "officialTitle"=>"Efficacy of Fascia Exercises in Migraine Patients: A Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"07.04.2022/06"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Treatment group", "description"=>"Patients in this group are the group to which fascia exercises are applied.", "interventionNames"=>["Other: Fascia exercises", "Other: Conventional physiotherapy and breathing exercises"]}, {"type"=>"OTHER", "label"=>"Control group", "description"=>"Patients in this group are the group to which conventional physiotherapy and breathing exercises are applied.", "interventionNames"=>["Other: Conventional physiotherapy and breathing exercises"]}], "interventions"=>[{"name"=>"Fascia exercises", "type"=>"OTHER", "description"=>"Fascia exercises are slow and calm movements similar to yoga performed by the person herself/himself.", "armGroupLabels"=>["Treatment group"]}, {"name"=>"Conventional physiotherapy and breathing exercises", "type"=>"OTHER", "description"=>"Head and neck exercises and breathing exercises", "armGroupLabels"=>["Control group", "Treatment group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"06760", "city"=>"Ankara", "state"=>"Çubuk", "country"=>"Turkey", "facility"=>"Ankara Yıldırım Beyazıt University", "geoPoint"=>{"lat"=>39.91987, "lon"=>32.85427}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Individual participant data will be available to the responsible researcher."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ankara Yildirim Beyazıt University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
