NCT05918146

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subdeltoid Bursitis
• Injection
• Effect of Drug

Interventions

Type	Name	Description
DRUG	Dextrose	Dextrose injection plus physical therapy
DRUG	Normal saline	Normal saline injection plus physical therapy

Timeline

• Start date: 2023-06-20
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2023-06-26
• Last updated: 2023-06-27

Locations

1 site across 1 country: Taiwan