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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05918146

Enrollment

Registered

2023-06-26

Start date

2023-06-20

Completion date

2024-06-30

Last updated

2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effect of Drug, Injection, Subdeltoid Bursitis

Keywords

subdeltoid bursitis, dextrose, physical therapy

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.

Interventions

DRUGDextrose

Dextrose injection plus physical therapy

DRUGNormal saline

Normal saline injection plus physical therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Shoulder pain and disability index	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

Measure	Time frame	Description
Disabilities of the arm, shoulder, and hand	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
Visual analog scale	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
range of motion	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

Countries

Taiwan

Contacts

Primary ContactRu-Lan Hsieh, MD

M001052@ms.skh.org.tw886-2-28332211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026