Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-07 @ 9:31 PM
Study NCT ID:
NCT01902433
Status:
TERMINATED
Last Update Posted:
2017-01-24
First Post:
2013-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Astym® Compared Eccentric Exercise for Chronic Mid-substance Achilles Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': {'whyStopped': 'We were unable to recruit participants to the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-21', 'studyFirstSubmitDate': '2013-07-15', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VISA-A', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Numeric Pain Rating Scale', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Achilles Tendon Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the changes in pain and self-perceived function between two different treatments for Achilles tendinopathy: the Astym® protocol (a form of soft tissue mobilization using instruments) and a specific exercise protocol that involves strengthening the calf and Achilles tendon. Astym® (A-stim) is not an acronym, but rather stands for "A Stimulation" of the body\'s healing response, describing the physiologic process which occurs with Astym treatment. Astym is the trademark name of a non-invasive treatment where instruments are applied topically to locate unhealthy soft tissue, and to transfer mild to moderate pressure to the underlying soft tissue structures. The aim of Astym treatment is to eliminate scar tissue and stimulate tissue regeneration. Both the principal investigator and co-investigator have been trained and certified in administering the Astym treatment. The specific exercise protocol will involve exercises that strengthen the Achilles and calf through eccentric exercise. Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Pain for 3 months or longer in the mid portion of only one Achilles tendon.\n* Must read, speak and understand English\n\nExclusion Criteria\n\n* Previous surgery to the Achilles tendon that is currently painful\n* An injection into the Achilles tendon in the previous 4 weeks\n* Have symptoms in both Achilles tendons concurrently\n* Have taken fluoroquinolone antibiotics in the past 6 months'}, 'identificationModule': {'nctId': 'NCT01902433', 'briefTitle': 'Astym® Compared Eccentric Exercise for Chronic Mid-substance Achilles Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Indianapolis'}, 'officialTitle': 'Astym® Treatment Compared With Eccentric Exercise in the Management of Chronic Mid-substance Achilles Tendinopathy: A Multisite a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ASTYM2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Astym', 'description': 'A form of soft tissue mobilization using instruments', 'interventionNames': ['Procedure: Astym']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Eccentric Exercise', 'description': 'Eccentric exercise is a form of exercise where the benefit comes from applying a controlled lengthening stress to the muscle and tendon.', 'interventionNames': ['Procedure: Astym']}], 'interventions': [{'name': 'Astym', 'type': 'PROCEDURE', 'armGroupLabels': ['Astym', 'Eccentric Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46254', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '84043', 'city': 'Lehi', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Physical Therapy', 'geoPoint': {'lat': 40.39162, 'lon': -111.85077}}], 'overallOfficials': [{'name': 'Emily J Slaven, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Indianapolis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Only two participants were recruited to the study at the closure of the study'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emily Slaven, PT, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Performance Dynamics', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Emily Slaven, PT, PhD', 'investigatorAffiliation': 'University of Indianapolis'}}}}