Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis

Subacromial Bursitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03447158
• Other study ID #: 18MMHIS001
• Status: Completed
• Phase: N/A
• Start date: July 18, 2018
• Est. completion date: January 23, 2020

Study information

• Verified date: January 2020
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 23, 2020
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Subacromial Bursitis

Intervention

Procedure:
• 15% Dextrose
inject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance
• Normal saline
inject normal saline and xylocaine into subacrominal bursa under sonographically guidance

Locations

Country	Name	City	State
Taiwan	MacKay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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