Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT03447158
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2018-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2018-02-14', 'studyFirstSubmitQcDate': '2018-02-25', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy', 'timeFrame': 'before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy', 'description': 'maximal visual analog scale (VAS) in the past week during shoulder activity. Visual analog scale is range from 0-10. The higher score indicated more severe pain.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline shoulder joint active range of motion (PROM) at 1 week, 1 month, and 3 months after 3rd section of therapy', 'timeFrame': 'before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy', 'description': 'abduction and flexion'}, {'measure': 'Change from Baseline Shoulder Pain and Disability Index (SPADI) score at 1 week, 1 month, and 3 months after 3rd section of therapy', 'timeFrame': 'before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy', 'description': 'Shoulder pain and disability questionnaire with two subscales, pain scale and function scale. Pain scale is range from 0-50. The higher scale indicates worse pain outcome. Function scale is range from 0-80. The higher scale indicates poor shoulder function. The total scale is summation of pain scale and function scale.'}, {'measure': 'Change from Baseline Ultrasound property at 1 week, 1 month, and 3 months after 3rd section of therapy', 'timeFrame': 'before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy', 'description': 'Thickness of bursa and elastogram'}, {'measure': 'Change from Baseline pain on resting at 1 week, 1 month, and 3 months after 3rd section of therapy', 'timeFrame': 'before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy', 'description': 'maximal visual analog scale (VAS) in the past week during resting. Visual analog scale is range from 0-10. The higher score indicated more severe pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subacromial Bursitis']}, 'referencesModule': {'references': [{'pmid': '32926850', 'type': 'DERIVED', 'citation': 'Chang YJ, Chang FH, Hou PH, Tseng KH, Lin YN. Effects of Hyperosmolar Dextrose Injection in Patients With Rotator Cuff Disease and Bursitis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Feb;102(2):245-250. doi: 10.1016/j.apmr.2020.08.010. Epub 2020 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to compare treatment efficacy of different concentration dextrose injection in chronic subacromial bursitis .', 'detailedDescription': 'Rotator cuff disorder with bursitis is one of the most frequent pathologies of the shoulder, which may cause serious restriction of daily activities and reduce quality of life. There are many ways in treating rotator cuff disorder with bursitis, including medication, physical therapy, kinesiological taping, acupuncture and local injection. Protholotherapy, which inject hyperosmolar dextrose to soft tissue, is a novel management in musculoskeletal disorders. However, only few trials exist in studying hyperosmolar dextrose injection for rotator cuff disorder with bursitis and most of them have small sample size and not randomized. The aim of this study was to figure out the effects of sonographically guided subacromial bursa injection with hyperosmolar dextrose in rotator cuff disorder with bursitis by a randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 20-65 years-old\n2. pain lasting \\>3 months\n3. Painful arc between 40° to 120° in abduction\n4. positive Neer and Hawkins-Kennedy tests\n5. positive Empty can test\n6. pain in daily living activities\n7. Bursa thickness more than 2mm in ultrasound\n8. Rotator cuff tendinopathy\n\nExclusion Criteria:\n\n1. history of significant shoulder trauma\n2. history of surgery, fracture, or dislocation\n3. adhesive capsulitis\n4. full thickness rotator cuff tear\n5. a long head of bicep tendon tear\n6. Contra-indications to local dextrose injection (known blood coagulation disorders, warfarin therapy, allergy to dextrose)\n7. previous shoulder steroid injection in one month\n8. had any rheumatologic, systemic, or neurologic disorders\n9. patients taking regular systemic NSAIDs or steroids\n10. pregnant or breastfeeding mothers\n11. malignancy'}, 'identificationModule': {'nctId': 'NCT03447158', 'briefTitle': 'Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis', 'organization': {'class': 'OTHER', 'fullName': 'Mackay Memorial Hospital'}, 'officialTitle': 'Effects of Hyperosmolar Dextrose Injection in Rotator Cuff Disorder With Bursitis : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '18MMHIS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '15% Dextrose group', 'description': '4.5cc 15% dextrose and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance', 'interventionNames': ['Procedure: 15% Dextrose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': '4.5cc normal saline and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance', 'interventionNames': ['Procedure: Normal saline']}], 'interventions': [{'name': '15% Dextrose', 'type': 'PROCEDURE', 'description': 'inject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance', 'armGroupLabels': ['15% Dextrose group']}, {'name': 'Normal saline', 'type': 'PROCEDURE', 'description': 'inject normal saline and xylocaine into subacrominal bursa under sonographically guidance', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'MacKay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mackay Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}