Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Subdeltoid Bursitis, Injection, Effect of Drug

Intervention / Treatment
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* Drug: Dextrose
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Dextrose injection, one time | Drug: Dextrose<br>* Dextrose injection plus physical therapy<br>* Other names: physical therapy;|
| Placebo Comparator: Control group<br>Normal saline injection, one time | Drug: Normal saline<br>* Normal saline injection plus physical therapy<br>* Other names: physical therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subdeltoid bursitis, dextrose, physical therapy