Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02123602
Status:
UNKNOWN
Last Update Posted:
2017-01-24
First Post:
2014-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Core Stabilization for the Treatment of Anterior Knee Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2014-04-23', 'studyFirstSubmitQcDate': '2014-04-24', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Global rating of change', 'timeFrame': '6 weeks', 'description': "The GRoC measures the subject's overall estimation of improvement."}, {'measure': 'Self-reported percent recovery', 'timeFrame': '6 weeks', 'description': 'The subject reports their estimated overall percentage of improvement from the start of care'}], 'primaryOutcomes': [{'measure': 'Lower extremity functional scale', 'timeFrame': '6 weeks', 'description': "LEFS is a functional scale that estimates how much the subject's function is disrupted by their condition."}], 'secondaryOutcomes': [{'measure': 'Kujala anterior knee pain scale', 'timeFrame': '6 weeks', 'description': "The Kujala scale measures the amount and impact of anterior knee pain on the subject's life"}, {'measure': 'Patient specific functional scale', 'timeFrame': '6 weeks', 'description': "The PSFS rates subject's ability to do the 3 functional activities that are bothered the most by the knee pain"}, {'measure': 'Numeric pain rating scale', 'timeFrame': '6 weeks', 'description': "The NPRS measures the subject's current knee pain"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['patellofemoral pain syndrome', 'abdominal muscles'], 'conditions': ['Patellofemoral Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '16526831', 'type': 'BACKGROUND', 'citation': 'Kibler WB, Press J, Sciascia A. The role of core stability in athletic function. Sports Med. 2006;36(3):189-98. doi: 10.2165/00007256-200636030-00001.'}, {'pmid': '19843565', 'type': 'BACKGROUND', 'citation': 'van Linschoten R, van Middelkoop M, Berger MY, Heintjes EM, Verhaar JA, Willemsen SP, Koes BW, Bierma-Zeinstra SM. Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial. BMJ. 2009 Oct 20;339:b4074. doi: 10.1136/bmj.b4074.'}, {'pmid': '22149696', 'type': 'BACKGROUND', 'citation': 'Collins NJ, Bisset LM, Crossley KM, Vicenzino B. Efficacy of nonsurgical interventions for anterior knee pain: systematic review and meta-analysis of randomized trials. Sports Med. 2012 Jan 1;42(1):31-49. doi: 10.2165/11594460-000000000-00000.'}, {'pmid': '20929936', 'type': 'BACKGROUND', 'citation': 'Earl JE, Hoch AZ. A proximal strengthening program improves pain, function, and biomechanics in women with patellofemoral pain syndrome. Am J Sports Med. 2011 Jan;39(1):154-63. doi: 10.1177/0363546510379967. Epub 2010 Oct 7.'}, {'pmid': '15733046', 'type': 'BACKGROUND', 'citation': 'Koumantakis GA, Watson PJ, Oldham JA. Trunk muscle stabilization training plus general exercise versus general exercise only: randomized controlled trial of patients with recurrent low back pain. Phys Ther. 2005 Mar;85(3):209-25.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that the use of trunk (core) stabilization exercises early in treatment combined with lower extremity exercises will enhance the outcome over lower extremity exercises alone in the treatment of young athletes with anterior knee pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects between 13-20 years of age clinically diagnosed with anterior knee pain.\n* Pain should be peripatellar and should include at least 3 of the following:\n\n 1. experienced during or after activity\n 2. prolonged sitting\n 3. with stair climbing or descending\n 4. squatting\n 5. kneeling.\n* The subject should be active for at least 30 minutes per day.\n\nExclusion Criteria:\n\n* Previous knee surgery\n* Signs and symptoms of a specific structural diagnosis not consistent with AKP such as meniscal, ACL, PCL, or collateral ligament tears, pain referral from hip or lumbar spine (determined during examination), traumatic patellar dislocation, an inability to adequately understand or communicate in English.'}, 'identificationModule': {'nctId': 'NCT02123602', 'briefTitle': 'Core Stabilization for the Treatment of Anterior Knee Pain', 'organization': {'class': 'OTHER', 'fullName': 'Youngstown State University'}, 'officialTitle': 'The Effects of a Trunk Strengthening Program on Anterior Knee Pain in an Adolescent Athletic Population: a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '#093-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Core stabilization', 'description': 'This arm will receive 3 weeks of core stabilization training followed by 3 weeks of lower extremity stretching and strengthening as appropriate to address impairments noted in the examination and to progress function.', 'interventionNames': ['Other: core stabilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lower extremity training only', 'description': 'This arm with receive 6 weeks of impairment based stretching and strengthening to restore function.', 'interventionNames': ['Other: lower extremity training only']}], 'interventions': [{'name': 'core stabilization', 'type': 'OTHER', 'armGroupLabels': ['Core stabilization']}, {'name': 'lower extremity training only', 'type': 'OTHER', 'armGroupLabels': ['Lower extremity training only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44514', 'city': 'Poland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Morris, DPT', 'role': 'CONTACT', 'phone': '330-757-7888'}], 'facility': 'Poland Medical Center', 'geoPoint': {'lat': 41.02423, 'lon': -80.6148}}], 'centralContacts': [{'name': 'Ken Learman, PhD, PT', 'role': 'CONTACT', 'email': 'klearman@ysu.edu', 'phone': '330.941.7125'}, {'name': 'Michael Morris, DPT', 'role': 'CONTACT', 'email': 'mjmorris107@yahoo.com', 'phone': '330.707.9064'}], 'overallOfficials': [{'name': 'Kenneth E Learman, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Youngstown State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Youngstown State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Physical Therapy', 'investigatorFullName': 'Kenneth Learman', 'investigatorAffiliation': 'Youngstown State University'}}}}