Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis

Effect of Drug Clinical Trial

Official title:

Effects of Hypertonic Dextrose Prolotherapy on Conventional Physical Therapy in Patients With Subdeltoid Bursitis: a Double-blind, Randomized, Placebo-controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05918146
• Other study ID #: 2023SKHADR033
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 20, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh, MD
• Phone: 886-2-28332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Effect of Drug
• Injection
• Subdeltoid Bursitis

Intervention

Drug:
• Dextrose
Dextrose injection plus physical therapy
• Normal saline
Normal saline injection plus physical therapy

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder pain and disability index	measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability	score change from baseline to 1 week, 1 month and 3 months after treatment
Secondary	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	score change from baseline to 1 week, 1 month and 3 months after treatment
Secondary	Visual analog scale	measure shoulder pain, ranges from 0-10, higher score indicate more pain	score change from baseline to 1 week, 1 month and 3 months after treatment
Secondary	range of motion	measure shoulder range of motion, higher score indicate higher range of motion	score change from baseline to 1 week, 1 month and 3 months after treatment