Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis

Taipei Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Injection; Subdeltoid Bursitis; Effect of Drug

Treatments: Drug: Dextrose; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05918146

2023SKHADR033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

Dextrose injection, one time

Treatment:

Drug: Dextrose

Control group

Placebo Comparator group

Description:

Normal saline injection, one time

Treatment:

Drug: Normal saline