Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis

Not Applicable

Completed

• Conditions: Subacromial Bursitis
• Interventions: Procedure: Normal saline; Procedure: 15% Dextrose

• Registration Number: NCT03447158
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-02-25
• Study First Posted: 2018-02-27
• Study Start: 2018-07-18
• Primary Completion: 2019-09-25
• Status Verified: 2020-01
• Study Completion: 2020-01-23
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. 20-65 years-old
2. pain lasting >3 months
3. Painful arc between 40° to 120° in abduction
4. positive Neer and Hawkins-Kennedy tests
5. positive Empty can test
6. pain in daily living activities
7. Bursa thickness more than 2mm in ultrasound
8. Rotator cuff tendinopathy

Exclusion Criteria

1. history of significant shoulder trauma
2. history of surgery, fracture, or dislocation
3. adhesive capsulitis
4. full thickness rotator cuff tear
5. a long head of bicep tendon tear
6. Contra-indications to local dextrose injection (known blood coagulation disorders, warfarin therapy, allergy to dextrose)
7. previous shoulder steroid injection in one month
8. had any rheumatologic, systemic, or neurologic disorders
9. patients taking regular systemic NSAIDs or steroids
10. pregnant or breastfeeding mothers
11. malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Normal saline	4.5cc normal saline and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance
15% Dextrose group	15% Dextrose	4.5cc 15% dextrose and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance

Primary Outcome Measures

Name	Time	Method
Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy	before therapy sections, 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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Shoulder Pain and Disability Index (SPADI) score at 1 week, 1 month, and 3 months after 3rd section of therapy	before therapy sections, 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.
Change from Baseline Ultrasound property at 1 week, 1 month, and 3 months after 3rd section of therapy	before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy	Thickness of bursa and elastogram
Change from Baseline shoulder joint active range of motion (PROM) at 1 week, 1 month, and 3 months after 3rd section of therapy	before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy	abduction and flexion
Change from Baseline pain on resting at 1 week, 1 month, and 3 months after 3rd section of therapy	before therapy sections, 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.

Trial Locations

Locations (1)

MacKay Memorial Hospital; 🇨🇳 Taipei, Taiwan