Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-05 @ 10:52 PM
Study NCT ID:
NCT03851367
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2019-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012544', 'term': 'Scheuermann Disease'}, {'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D055035', 'term': 'Spinal Osteochondrosis'}, {'id': 'D055034', 'term': 'Osteochondrosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007738', 'term': 'Kyphosis'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects were recruited from an inpatient rehabilitation department, specializing in the treatment of children and adolescents with degenerative disorders. The research population consisted of 40 adolescents-girls, who were diagnosed with juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42.0). All subjects were randomly divided into two groups: Sling Suspension Therapy, and Gymball therapy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-22', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Back pain', 'timeFrame': 'baseline', 'description': 'was evaluated using the Visual Analogue Pain Scale (VAS). Participants were asked to report "current" pain intensity. A higher score indicates greater pain intensity: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).'}, {'measure': 'Endurance of the trunk muscles', 'timeFrame': 'baseline', 'description': 'was tested according those suggested by S. McGill (2007) and endurance duration was recorder in seconds. The back extensors ; The trunk flexors ; The lateral musculature'}, {'measure': 'Weight', 'timeFrame': 'baseline', 'description': 'Body weight was measured in kilograms with an accuracy of 100 g'}, {'measure': 'Height', 'timeFrame': 'baseline', 'description': 'Body height was measured in meters with an accuracy of 5 mm'}, {'measure': 'Posture evaluation', 'timeFrame': 'baseline', 'description': "Standing posture was evaluated by a commonly used clinical assessment technique - visual assessment. In an attempt to minimize data collection error, one experienced examiner evaluated all the study participants' posture. The examiner was blind to the scope of the study and to the group that the subjects belonged to."}], 'secondaryOutcomes': [{'measure': 'Change in Back pain', 'timeFrame': '3 weeks', 'description': 'was evaluated using the Visual Analogue Pain Scale (VAS). Participants were asked to report "current" pain intensity. A higher score indicates greater pain intensity: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).'}, {'measure': 'Change in Endurance of the trunk muscles', 'timeFrame': '3 weeks', 'description': 'was tested according those suggested by S. McGill (2007) and endurance duration was recorder in seconds. The back extensors ; The trunk flexors ; The lateral musculature'}, {'measure': 'Improvement in Posture evaluation', 'timeFrame': '3 weeks', 'description': "Standing posture was evaluated by a commonly used clinical assessment technique - visual assessment. In an attempt to minimize data collection error, one experienced examiner evaluated all the study participants' posture. The examiner was blind to the scope of the study and to the group that the subjects belonged to."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['back pain', 'suspension therapy', 'Gymball', 'standing posture', 'muscle endurance'], 'conditions': ['Juvenile Osteochondrosis of Spine']}, 'descriptionModule': {'briefSummary': 'This study compares effect of swiss ball exercises with sling suspension exercises in the treatment of juvenile osteochondrosis in adolescent-girls', 'detailedDescription': 'One of the main tasks in the treatment of osteochondrosis related back pain is training trunk stabilizing muscles. This might be achieved by using a sling suspension exercise systems. Redcord is a trademark for Sling Exercise Therapy. Suspension exercise training has been shown to improves functional movement patterns more effectively than traditional exercise by creating a challenging and pain free environment for movement re-training. Another commonly used option in the treatment of juvenile osteochondrosis is Gymball, also known as Swissball core training programmes that are popular trends in physiotherapy and strength and conditioning programs. Benefits of Gymball core training exercises that facilitate spinal stability and balance have often been emphasized by researchers in development of strength and endurance, flexibility, and neuromuscular control as a cost effective and enjoyable way to treat and prevent back pain. Both exercises modes are used in treatment of back pain and muscle training in young people with juvenile osteochondrosis, what is why this study aims to compare Sling Suspension therapy with Gymball exercise in this population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'genderBased': True, 'genderDescription': 'only adolescents girls', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis - juvenile osteochondrosis (according to the International classification of Diseases - ICD M 42 gender: female\n\nExclusion Criteria:\n\n* any other medical diagnosis'}, 'identificationModule': {'nctId': 'NCT03851367', 'briefTitle': 'Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis', 'organization': {'class': 'OTHER', 'fullName': 'Lithuanian Sports University'}, 'officialTitle': 'Sling Suspension Versus Gym Balls in the Treatment of Juvenile Spinal Osteochondrosis in Adolescent Girls', 'orgStudyIdInfo': {'id': 'LithuanianSportsU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sling suspension therapy', 'description': '3-week duration of exercises using red cord and consisting of 15 sessions for 30 minutes each.', 'interventionNames': ['Procedure: Sling suspension using red cord']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Swiss ball therapy', 'description': '3-week duration exercise for trunk muscles strengthening and posture improvement consisting of 15 sessions for 30 minutes each.', 'interventionNames': ['Procedure: Gym ball exercises']}], 'interventions': [{'name': 'Sling suspension using red cord', 'type': 'PROCEDURE', 'otherNames': ['SST'], 'description': '3 weeks duration, 15 sessions, and 30 minutes a day for five consecutive days a week. Back pain, endurance of trunk muscles (flexors, extensors and side flexors), and standing posture were evaluated pre and post interventions.', 'armGroupLabels': ['Sling suspension therapy']}, {'name': 'Gym ball exercises', 'type': 'PROCEDURE', 'otherNames': ['GBT'], 'description': '3 weeks duration, 15 sessions, and 30 minutes a day for five consecutive days a week. Back pain, endurance of trunk muscles (flexors, extensors and side flexors), and standing posture were evaluated pre and post interventions.', 'armGroupLabels': ['Swiss ball therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44221', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Vilma Dudoniene', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'There is a plan to share IPD with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lithuanian Sports University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lithuanian University of Health Sciences', 'class': 'OTHER'}, {'name': 'University of Brighton', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}