Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis

Study Overview
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Brief Summary
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The main purpose of this study is to compare treatment efficacy of different concentration dextrose injection in chronic subacromial bursitis .

Detailed Description
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Rotator cuff disorder with bursitis is one of the most frequent pathologies of the shoulder, which may cause serious restriction of daily activities and reduce quality of life. There are many ways in treating rotator cuff disorder with bursitis, including medication, physical therapy, kinesiological taping, acupuncture and local injection. Protholotherapy, which inject hyperosmolar dextrose to soft tissue, is a novel management in musculoskeletal disorders. However, only few trials exist in studying hyperosmolar dextrose injection for rotator cuff disorder with bursitis and most of them have small sample size and not randomized. The aim of this study was to figure out the effects of sonographically guided subacromial bursa injection with hyperosmolar dextrose in rotator cuff disorder with bursitis by a randomized controlled trial.

Official Title
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Effects of Hyperosmolar Dextrose Injection in Rotator Cuff Disorder With Bursitis : A Randomized Controlled Trial

Conditions
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Subacromial Bursitis

Intervention / Treatment
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* Procedure: 15% Dextrose
* Procedure: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20-65 years-old pain lasting >3 months Painful arc between 40° to 120° in abduction positive Neer and Hawkins-Kennedy tests positive Empty can test pain in daily living activities Bursa thickness more than 2mm in ultrasound Rotator cuff tendinopathy Exclusion Criteria: history of significant shoulder trauma history of surgery, fracture, or dislocation adhesive capsulitis full thickness rotator cuff tear a long head of bicep tendon tear Contra-indications to local dextrose injection (known blood coagulation disorders, warfarin therapy, allergy to dextrose) previous shoulder steroid injection in one month had any rheumatologic, systemic, or neurologic disorders patients taking regular systemic NSAIDs or steroids pregnant or breastfeeding mothers malignancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 15% Dextrose group<br>4.5cc 15% dextrose and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance | Procedure: 15% Dextrose<br>* inject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance<br>|
| Placebo Comparator: control group<br>4.5cc normal saline and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance | Procedure: Normal saline<br>* inject normal saline and xylocaine into subacrominal bursa under sonographically guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy | maximal visual analog scale (VAS) in the past week during shoulder activity. Visual analog scale is range from 0-10. The higher score indicated more severe pain. | before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline shoulder joint active range of motion (PROM) at 1 week, 1 month, and 3 months after 3rd section of therapy | abduction and flexion | before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy | 
| Change from Baseline Shoulder Pain and Disability Index (SPADI) score at 1 week, 1 month, and 3 months after 3rd section of therapy | Shoulder pain and disability questionnaire with two subscales, pain scale and function scale. Pain scale is range from 0-50. The higher scale indicates worse pain outcome. Function scale is range from 0-80. The higher scale indicates poor shoulder function. The total scale is summation of pain scale and function scale. | before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy | 
| Change from Baseline Ultrasound property at 1 week, 1 month, and 3 months after 3rd section of therapy | Thickness of bursa and elastogram | before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy | 
| Change from Baseline pain on resting at 1 week, 1 month, and 3 months after 3rd section of therapy | maximal visual analog scale (VAS) in the past week during resting. Visual analog scale is range from 0-10. The higher score indicated more severe pain. | before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy |