Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-26 @ 1:38 AM
Study NCT ID:
NCT01449994
Status:
COMPLETED
Last Update Posted:
2012-02-08
First Post:
2011-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Instrumental Chiropractic Treatment Using Activator Methods for Pain and Dysfunction in Juvenile Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-07', 'studyFirstSubmitDate': '2011-07-20', 'studyFirstSubmitQcDate': '2011-10-07', 'lastUpdatePostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of Pain', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['knee', 'hip', 'ankle', 'foot', 'pain', 'lower limb', 'activator', 'instrumental', 'chiropractic', 'Painful functional conditions of the lower extremity'], 'conditions': ['Pain in Leg, Unspecified', 'Knee Sprain']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to prove efficacy of instrumental chiropractic treatment for leg pain in juvenile athletes.\n\nA randomized placebo controlled clinical trial including juvenile athletes with functional impairment and pain in thigh, leg or foot is performed.\n\nHypothesis: Instrumental chiropractic treatment with the "activator instrument "following the "activator methods" diagnostic evaluation should lead to significant improvement of complaints and functional impairment compared to the control group treated by a deactivated instrument following a sham evaluation protocol.', 'detailedDescription': 'Pain and functional impairment may force young athletes to interrupt training plans and/or even stay away from competition. Usually elite athletes run through an abundance of tests and diagnostic features-too often these high cost diagnostics don´t provide useful information for treatment. Treating the symptoms in the first place (after ruling out severe pathology) will reduce the need for extensive diagnostic routines and bring athletes back to competition earlier.\n\nIn our outpatient department of young elite sportsmen chiropractic instrumental treatment is performed routinely- mostly a pain reduction of 3-4 levels in VAS is achieved within the first session of treatment.\n\nThe following study is thought to prove the efficacy of the Chiropractic Instrumental Treatment performed at our sports-medicine outpatient department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* functional problems in the lower extremities\n\nExclusion Criteria:\n\n* severe pathology that requires different treatment'}, 'identificationModule': {'nctId': 'NCT01449994', 'briefTitle': 'Efficacy of Instrumental Chiropractic Treatment Using Activator Methods for Pain and Dysfunction in Juvenile Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Efficacy of Instrumental Chiropractic Treatment Using Activator Methods for Pain and Dysfunction.A Randomized Placebo-controlled Clinical Study on Juvenile Athletes With Leg Pain', 'orgStudyIdInfo': {'id': 'Activator in Austria'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-Activator', 'description': 'Treatment with Placebo Activator IV', 'interventionNames': ['Device: Activator IV (Activator Methods Int. Phoenix, Arizona)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Activator', 'description': 'Treatment with Activator IV adjusting instrument', 'interventionNames': ['Device: Activator IV (Activator Methods Int. Phoenix, Arizona)']}], 'interventions': [{'name': 'Activator IV (Activator Methods Int. Phoenix, Arizona)', 'type': 'DEVICE', 'otherNames': ['Chiropractic adjusting instrument'], 'description': 'Instruments gives a defined impulse on specified areas of the body', 'armGroupLabels': ['Activator', 'Placebo-Activator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'MedUni Graz Pediatric Surgery and Ped. Orthopedics', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'overallOfficials': [{'name': 'Frank J Schneider, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meical University Graz Department of pediatric orthopedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior orthopedic surgeon', 'investigatorFullName': 'Frank Schneider, MD', 'investigatorAffiliation': 'Medical University of Graz'}}}}