Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-08 @ 11:44 PM
Study NCT ID:
NCT04689295
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2020-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life before and after treatment', 'timeFrame': '6 weeks', 'description': 'quality of life assessment will be done with SRS-22 (scoliosis research society 22 form)(min:1, max:5 pts.)'}], 'primaryOutcomes': [{'measure': 'Pain Level', 'timeFrame': '6 weeks', 'description': 'Pain level will be assessed with VAS (visual analog scale) (min:0, max:10)'}, {'measure': 'Pressure Pain Threshold', 'timeFrame': '6 weeks', 'description': 'Pressure pain threshold with algometer (kg/cm\\^2).'}], 'secondaryOutcomes': [{'measure': 'Body awareness before and after treatment', 'timeFrame': '6 weeks', 'description': 'body awareness assessment will be done with body awareness questionnaire (min:18, max:126 pts.)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schroth', 'idiopathic scoliosis', 'pain', 'quality of life', 'body awareness'], 'conditions': ['Scoliosis']}, 'descriptionModule': {'briefSummary': 'This study was aimed to compare the effect of Schroth therapy method, which is a 3-dimensional scoliosis exercise method, and traditional exercises on pain, body awareness and quality of life in young individuals with idiopathic scoliosis.', 'detailedDescription': "38 individuals aged between 10-18 with the diagnosis of idiopathic scoliosis will be participated in the study. Individuals (study group) underwent 1 hour exercise program 3 times a week for 6 weeks, and the individuals (control group) undervent a traditional exercise program once a week under supervision of physiotherapist for 6 weeks. During the rest of the week, same exercise program was given as a home program for at least half an hour a day and individuals will followed up. Individuals' subjective pain intensity will be assessed with Visual Analogue Scale (VAS), pressure pain threshold by algometer, body awareness by Turkish version of Body Awareness Questionnaire and quality of life by Turkish version of Scoliosis Research Society (SRS)-22 scale. Measurements will be performed before and after the 6-week exercise program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having been diagnosed with idiopathic scoliosis by a specialist physician,\n* Between the ages of 10-18,\n* Primary curvature between 20-40 degrees according to the Cobb method,\n* Having C or S type of scoliosis,\n* Having back / low-back pain due to scoliosis,\n* Those who have not received any previous exercise therapy for scoliosis,\n* Volunteering to participate in the study,\n* Having the cognitive capacity to cooperate with the directions of the physiotherapist,\n* Has not suffered any injuries to the musculoskeletal system in the last 6 months,\n* No neurological, orthopedic or cardiopulmonary disorders other than scoliosis diagnosis,\n* Young individuals who have not undergone any surgery related to the diagnosis of scoliosis\n\nExclusion Criteria:\n\n* Previous spinal surgery,\n* Any disease other than idiopathic scoliosis,\n* Individuals who cannot adapt to the directions of the physiotherapist and cannot fulfill the requirements of the exercise program'}, 'identificationModule': {'nctId': 'NCT04689295', 'briefTitle': 'The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis', 'orgStudyIdInfo': {'id': '2019/0041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'experiment group', 'description': 'Three dimensional scoliosis therapy method (Schroth) will be applied to the participants for 6 weeks. It consist of 15 different exercises combined with rotational breathing exercise.', 'interventionNames': ['Other: exercise programme 1']}, {'type': 'OTHER', 'label': 'control group', 'description': 'Traditional scoliosis exercises will be applied to the participants for 6 weeks. It consist of 6 different exercises', 'interventionNames': ['Other: exercise programme 2']}], 'interventions': [{'name': 'exercise programme 1', 'type': 'OTHER', 'description': 'Schroth three dimensional scoliosis therapy method', 'armGroupLabels': ['experiment group']}, {'name': 'exercise programme 2', 'type': 'OTHER', 'description': 'Traditional scoliosis exercises', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Fizyo Omurga', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'fatih çelik', 'role': 'STUDY_DIRECTOR', 'affiliation': 'physiotherapist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Fatih Çelik', 'investigatorAffiliation': 'Hacettepe University'}}}}