Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis

Phase 4

Not yet recruiting

• Conditions: Subdeltoid Bursitis; Injection; Effect of Drug
• Interventions: Drug: Normal saline; Drug: Dextrose

• Registration Number: NCT05918146
• Lead Sponsor: Taipei Medical University

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.

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-15
• Study Start: 2023-06-20
• Last Update Submitted: 2023-06-23
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-27
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Normal saline	Normal saline injection, one time
Intervention group	Dextrose	Dextrose injection, one time

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan