Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT04848103
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2021-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000267', 'term': 'Tissue Adhesions'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '. Pain intensity', 'timeFrame': 'Change from baseline pain intensity at 2 weeks', 'description': 'A numeric pain rating scale (NPRS) consisting of 11 points in total from 0 points (no pain) to 10 points (the most severe pain imaginable) is used. The lower the score, the less the pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Injuries', 'Pain, Postoperative', 'Tissue Adhesion']}, 'referencesModule': {'references': [{'pmid': '36107497', 'type': 'DERIVED', 'citation': 'Kim HJ, Choi W, Jung J, Park S, Joo Y, Lee S, Lee S. Efficacy of radial extracorporeal shockwave therapy in rehabilitation following arthroscopic rotator cuff repair: A STROBE compliant study. Medicine (Baltimore). 2022 Sep 2;101(35):e30053. doi: 10.1097/MD.0000000000030053.'}]}, 'descriptionModule': {'briefSummary': 'Although radial extracorporeal shock wave therapy (rESWT) has proven to be an effective treatment, the effectiveness of the treatment has so far been controversial. There are no studies using rESWT in rehabilitation after arthroscopic rotator cuff repair (ARCR). Therefore, in this study, there is evidence that rESWT promotes pain control and healing recovery, and through previous studies, we would like to investigate whether treatment with rESWT during the intensive rehabilitation period of patients after ARCR is more effective in controlling pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over 18 years old\n* In case of 6 weeks after receiving arthroscopic rotator cuff repair\n* When the participants wishes to enroll in the study\n\nExclusion Criteria:\n\n* 65 years old or older\n* If the tear area is large and augmentation is performed\n* If there is a previous surgical history at the surgical site\n* Osteoarthritis in the shoulder joint'}, 'identificationModule': {'nctId': 'NCT04848103', 'briefTitle': 'Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': 'Sahmyook University'}, 'officialTitle': 'Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair', 'orgStudyIdInfo': {'id': '2-1040781-A-N-012021035HR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radial extracorporeal shockwave therapy', 'interventionNames': ['Behavioral: Radial extracorporeal shockwave therapy']}], 'interventions': [{'name': 'Radial extracorporeal shockwave therapy', 'type': 'BEHAVIORAL', 'description': 'Radial extracorporeal shockwave therapy group include Therapeutic modality(Transcutaneous electrical nerve stimulation \\[TENS\\], Microwave thermotherapy, and Superficial heat therapy), Range of motion exercise(Continuous passive motion and Active range of motion exercise).', 'armGroupLabels': ['Radial extracorporeal shockwave therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61085', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'The Better Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}], 'overallOfficials': [{'name': 'Hyun-Joong Kim, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahmyook University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Hyun-Joong Kim', 'investigatorAffiliation': 'Sahmyook University'}}}}