Effects of Ultrasound-guide Hypertonic Dextrose Injection for Chronic Subacromial Bursitis
1 other identifier
interventional
60
1 country
2
Brief Summary
The aim of this study is to investigate the echoguide hypertonic injection and compared steroid injection in subacromial bursitis patients about clinical and ultrasound image presentation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2021
CompletedFirst Posted
Study publicly available on registry
June 7, 2021
CompletedStudy Start
First participant enrolled
June 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 5, 2021
September 1, 2021
6 months
June 2, 2021
September 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Shoulder Pain and Disability Index (change of SPADI)
Shoulder Pain and Disability Index (SPADI), a self-administered assessment tool that was used to measure pain and disability related to shoulder disease. The SPADI consists of 5 pain and 8 disability items that are measured on a visual analog scale. Pain and disability subscales were calculated as the mean of the corresponding items on a 0-100 scale; the highest score indicated the most severe pain and disability. The total outcome score used for statistical analysis was calculated as the sum of the pain and disability subscales.
Week0 Week2 Week6 Week12
Secondary Outcomes (3)
Ultrasound
Week0 Week2 Week6 Week12
Shoulder ROM (Range of Motion)
Week0 Week2 Week6 Week12
Pain (VAS, Visual Analogue Scale)
Week0 Week2 Week6 Week12
Study Arms (2)
20% hypertonic dextrose water injection group
EXPERIMENTALecho guide 20% dextrose water 3ml was injection in lesion site
Steroid injection group
ACTIVE COMPARATORTriamcinolone Acetonide 40mg/ml, 1ml, and Lidocaine 2ml as the active comparator group
Interventions
20% hypertonic dextrose water injection for chronic shoulder pain
Triamcinolone Acetonide 40mg/1ml injection
Eligibility Criteria
You may qualify if:
- Aged more than 20 years old with diagnosis of chronic supraspinatus tendinosis by ultrasound and clinical shoulder pain lasting for more than 3 months.
You may not qualify if:
- History of shoulder fracture and operation, with frozen shoulder or full thickness ruptur of rotator cuff, steroid, or hyaluronic acid, or platelet rich plasma (PRP) injection during the period of intervention and following up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shuang Ho Hospital
New Taipei City, Zhonghe Dist, 235, Taiwan
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Zhonghe Dist, 235, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lien-Chieh Lin
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
June 2, 2021
First Posted
June 7, 2021
Study Start
June 10, 2021
Primary Completion
November 30, 2021
Study Completion
December 31, 2021
Last Updated
September 5, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share