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Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05918146
Recruitment Status : Not yet recruiting
First Posted : June 26, 2023
Last Update Posted : June 27, 2023
Sponsor:
Information provided by (Responsible Party):
Ru-Lan Hsieh, Taipei Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Subdeltoid Bursitis Injection Effect of Drug Drug: Dextrose Drug: Normal saline Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Hypertonic Dextrose Prolotherapy on Conventional Physical Therapy in Patients With Subdeltoid Bursitis: a Double-blind, Randomized, Placebo-controlled Study
Estimated Study Start Date : June 20, 2023
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Dextrose injection, one time
 Drug: Dextrose
Dextrose injection plus physical therapy
Other Name: physical therapy
Placebo Comparator: Control group
Normal saline injection, one time
 Drug: Normal saline
Normal saline injection plus physical therapy
Other Name: physical therapy


Outcome Measures
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Primary Outcome Measures :
  1. Shoulder pain and disability index [ Time Frame: score change from baseline to 1 week, 1 month and 3 months after treatment ]
    measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability


Secondary Outcome Measures :
  1. Disabilities of the arm, shoulder, and hand [ Time Frame: score change from baseline to 1 week, 1 month and 3 months after treatment ]
    measure sports/music and work related to shoulder pain, ranges from 0-100, higher scores indicate more pain or disability

  2. Visual analog scale [ Time Frame: score change from baseline to 1 week, 1 month and 3 months after treatment ]
    measure shoulder pain, ranges from 0-10, higher score indicate more pain

  3. range of motion [ Time Frame: score change from baseline to 1 week, 1 month and 3 months after treatment ]
    measure shoulder range of motion, higher score indicate higher range of motion


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05918146


Contacts
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Contact: Ru-Lan Hsieh, MD 886-2-28332211 ext 2531 M001052@ms.skh.org.tw

Locations
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Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111-01
Sponsors and Collaborators
Taipei Medical University
Investigators
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Study Chair: Ru-Lan Hsieh, MD Shin Kong Wu Ho-Su Memorial Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ru-Lan Hsieh, MD, Professor, Taipei Medical University
ClinicalTrials.gov Identifier: NCT05918146    
Other Study ID Numbers: 2023SKHADR033
First Posted: June 26, 2023    Key Record Dates
Last Update Posted: June 27, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ru-Lan Hsieh, Taipei Medical University:
subdeltoid bursitis
dextrose
physical therapy
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases