Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis
Effects of Hypertonic Dextrose Prolotherapy on Conventional Physical Therapy in Patients With Subdeltoid Bursitis: a Double-blind, Randomized, Placebo-controlled Study
1 other identifier
interventional
46
1 country
1
Brief Summary
Physical therapy and hypertonic dextrose prolotherapy are often used to treat subdeltoid bursitis. This study aims to investigate the effects of hypertonic dextrose injection on physical therapy through a double-blind, randomized study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2023
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2023
CompletedStudy Start
First participant enrolled
June 20, 2023
CompletedFirst Posted
Study publicly available on registry
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJune 27, 2023
June 1, 2023
1 year
June 15, 2023
June 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Shoulder pain and disability index
measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability
score change from baseline to 1 week, 1 month and 3 months after treatment
Secondary Outcomes (3)
Disabilities of the arm, shoulder, and hand
score change from baseline to 1 week, 1 month and 3 months after treatment
Visual analog scale
score change from baseline to 1 week, 1 month and 3 months after treatment
range of motion
score change from baseline to 1 week, 1 month and 3 months after treatment
Study Arms (2)
Intervention group
EXPERIMENTALDextrose injection, one time
Control group
PLACEBO COMPARATORNormal saline injection, one time
Interventions
Dextrose injection plus physical therapy
Normal saline injection plus physical therapy
Eligibility Criteria
You may qualify if:
- clinical diagnosis of subdeltoid bursitis age 20 or older 20 at least one positive in the painful arc, neer test, or Hawkins test can attend 3 months of intervention and follow up
You may not qualify if:
- history of malignancy previous shoulder operation or injury previous shoulder injections in the past 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111-01, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ru-Lan Hsieh, MD
Shin Kong Wu Ho-Su Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Professor
Study Record Dates
First Submitted
June 15, 2023
First Posted
June 26, 2023
Study Start
June 20, 2023
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
June 27, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share