Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-07 @ 9:45 PM
Study NCT ID:
NCT03198260
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2017-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observing the Effect of Fascial Manipulation in Athletes With Shin Splits.Tibial Stress Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058923', 'term': 'Medial Tibial Stress Syndrome'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-27', 'studyFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-06-22', 'lastUpdatePostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale', 'timeFrame': 'After 5 to 10 mins', 'description': 'Self reporting pain intensity after resuming running'}], 'secondaryOutcomes': [{'measure': 'Increase in running economy', 'timeFrame': '15 mins to 45 mins', 'description': 'Increasing in duration of running compared to the first trial'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shin Splint', 'Fascial Manipulation', 'Running Kinematics']}, 'referencesModule': {'references': [{'pmid': '22341017', 'type': 'RESULT', 'citation': 'Reshef N, Guelich DR. Medial tibial stress syndrome. Clin Sports Med. 2012 Apr;31(2):273-90. doi: 10.1016/j.csm.2011.09.008.'}, {'pmid': '27835043', 'type': 'RESULT', 'citation': 'Winkelmann ZK, Anderson D, Games KE, Eberman LE. Risk Factors for Medial Tibial Stress Syndrome in Active Individuals: An Evidence-Based Review. J Athl Train. 2016 Dec;51(12):1049-1052. doi: 10.4085/1062-6050-51.12.13. Epub 2016 Nov 11.'}, {'pmid': '24379729', 'type': 'RESULT', 'citation': 'Newman P, Witchalls J, Waddington G, Adams R. Risk factors associated with medial tibial stress syndrome in runners: a systematic review and meta-analysis. Open Access J Sports Med. 2013 Nov 13;4:229-41. doi: 10.2147/OAJSM.S39331.'}, {'pmid': '27066291', 'type': 'RESULT', 'citation': 'Brown AA. Medial Tibial Stress Syndrome: Muscles Located at the Site of Pain. Scientifica (Cairo). 2016;2016:7097489. doi: 10.1155/2016/7097489. Epub 2016 Mar 15.'}, {'pmid': '26616185', 'type': 'RESULT', 'citation': 'Souza RB. An Evidence-Based Videotaped Running Biomechanics Analysis. Phys Med Rehabil Clin N Am. 2016 Feb;27(1):217-36. doi: 10.1016/j.pmr.2015.08.006. Epub 2015 Oct 20.'}, {'pmid': '23979968', 'type': 'RESULT', 'citation': 'Winters M, Eskes M, Weir A, Moen MH, Backx FJ, Bakker EW. Treatment of medial tibial stress syndrome: a systematic review. Sports Med. 2013 Dec;43(12):1315-33. doi: 10.1007/s40279-013-0087-0.'}, {'pmid': '26591110', 'type': 'RESULT', 'citation': 'Mikolajczyk A, Kociecki M, Zaklukiewicz A, Listewnik M, Gebska M. [USE OF THE STRUCTURAL TENSEGRATION CONCEPT IN THE STECCO FASCIAL MANIPULATION METHOD]. Ann Acad Med Stetin. 2014;60(2):59-64. Polish.'}, {'pmid': '21589701', 'type': 'RESULT', 'citation': 'Stecco C, Day JA. The fascial manipulation technique and its biomechanical model: a guide to the human fascial system. Int J Ther Massage Bodywork. 2010 Mar 17;3(1):38-40. doi: 10.3822/ijtmb.v3i1.78. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Aims \\& objectives:\n\n1. The aim of the study is to find out the influence of fascial manipulation on running kinematics among athletes with medial tibial stress syndrome (MTSS).\n2. The objectives of our study are\n\ni. To use fascial manipulation as a mode of treatment in MTSS. ii. To compare running kinematics before and after treatment intervention. iii. To compare pain perception before and after treatment intervention.', 'detailedDescription': 'The justification for study:\n\n1. MTSS is associated with altered lower extremity kinematics.\n2. There is an association between tibial fascia tightness and forces acting along the tibial crest due to alterations in the transfer of energy from foot proximally in the closed kinematic chain.\n3. Fascial manipulation is found to be effective in improving the pliability of connective tissues in the management of musculoskeletal conditions.\n4. Therefore there is a need to determine the influence of fascial manipulation on MTSS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 18-40 years, both sexes Athletes with shin pain or diagnosed with MTSS Symptoms lasting for 2-3 weeks in the last 1 month\n\nExclusion Criteria:\n\n* Trauma to lower extremity in the past 3 months Neurological, Cognitive, Psychological factors affecting the test Acute injuries- laceration, sprains, strains, recent fractures Lumbopelvic-hip complex and knee pathologies(intra-articular lesions, osteoarthritis, rheumatic arthritis, osteomyelitis)'}, 'identificationModule': {'nctId': 'NCT03198260', 'acronym': 'MTSS', 'briefTitle': 'Observing the Effect of Fascial Manipulation in Athletes With Shin Splits.Tibial Stress Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Manipal University'}, 'officialTitle': 'Influence of Fascial Manipulation on Running Kinematics Among Athletes With Medial Tibial Stress Syndrome.', 'orgStudyIdInfo': {'id': 'CTRI/2017/06/008875'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fascial Manipulation', 'description': 'fascial manipulation is a manual therapy technique were to apply deep frictional massage to the deep fascial structure or point to increase its pliability', 'interventionNames': ['Other: Fascial manipulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Running kinematics', 'description': 'the change in a range of joint angles during different phases of running', 'interventionNames': ['Other: Fascial manipulation']}], 'interventions': [{'name': 'Fascial manipulation', 'type': 'OTHER', 'description': 'Deep frictional massage', 'armGroupLabels': ['Fascial Manipulation', 'Running kinematics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '576104', 'city': 'Udupi', 'state': 'Karnataka', 'country': 'India', 'facility': 'Center for Sport Science Medicine and Research', 'geoPoint': {'lat': 13.33467, 'lon': 74.74617}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manipal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postgraduate student', 'investigatorFullName': 'Siddhant Shipurka', 'investigatorAffiliation': 'Manipal University'}}}}