Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis
Primary Purpose
Subdeltoid Bursitis, Injection, Effect of Drug
Status
Not yet recruiting
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Dextrose
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Subdeltoid Bursitis focused on measuring subdeltoid bursitis, dextrose, physical therapy
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: history of malignancy previous shoulder operation or injury previous shoulder injections in the past 3 months
Sites / Locations
- Shin Kong Wu Ho-Su Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention group
Control group
Arm Description
Dextrose injection, one time
Normal saline injection, one time
Outcomes
Primary Outcome Measures
Shoulder pain and disability index
measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability
Secondary Outcome Measures
Disabilities of the arm, shoulder, and hand
measure sports/music and work related to shoulder pain, ranges from 0-100, higher scores indicate more pain or disability
Visual analog scale
measure shoulder pain, ranges from 0-10, higher score indicate more pain
range of motion
measure shoulder range of motion, higher score indicate higher range of motion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05918146
Brief Title
Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis
Official Title
Effects of Hypertonic Dextrose Prolotherapy on Conventional Physical Therapy in Patients With Subdeltoid Bursitis: a Double-blind, Randomized, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
A double-blind, randomized, placebo-controlled clinical trial will be conducted to collect 44 patients with subdeltoid bursitis. In the first week and the third week, a total of 20% hypertonic dextrose 10 mL (experimental group) and normal saline 10 mL (placebo group) will be injected under sonographic guidance, and physical therapy (hot shoulder pack, interference wave, and exercise for 20 minutes each) 3 times per week for one month will be arranged. Shoulder pain by visual analog scale, function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) and high-resolution ultrasound examination will be arranged at before treatment, one week after treatment (i.e., one week after injection), one month, and three months after injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subdeltoid Bursitis, Injection, Effect of Drug
Keywords
subdeltoid bursitis, dextrose, physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Dextrose injection, one time
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Normal saline injection, one time
Intervention Type
Drug
Intervention Name(s)
Dextrose
Other Intervention Name(s)
physical therapy
Intervention Description
Dextrose injection plus physical therapy
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
physical therapy
Intervention Description
Normal saline injection plus physical therapy
Primary Outcome Measure Information:
Title
Shoulder pain and disability index
Description
measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability
Time Frame
score change from baseline to 1 week, 1 month and 3 months after treatment
Secondary Outcome Measure Information:
Title
Disabilities of the arm, shoulder, and hand
Description
measure sports/music and work related to shoulder pain, ranges from 0-100, higher scores indicate more pain or disability
Time Frame
score change from baseline to 1 week, 1 month and 3 months after treatment
Title
Visual analog scale
Description
measure shoulder pain, ranges from 0-10, higher score indicate more pain
Time Frame
score change from baseline to 1 week, 1 month and 3 months after treatment
Title
range of motion
Description
measure shoulder range of motion, higher score indicate higher range of motion
Time Frame
score change from baseline to 1 week, 1 month and 3 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
history of malignancy previous shoulder operation or injury previous shoulder injections in the past 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ru-Lan Hsieh, MD
Phone
886-2-28332211
Ext
2531
Email
M001052@ms.skh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Lan Hsieh, MD
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111-01
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis
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