Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis

Mackay Memorial Hospital

Status: Completed

Conditions: Subacromial Bursitis

Treatments: Procedure: 15% Dextrose; Procedure: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03447158

18MMHIS001

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

15% Dextrose group

Experimental group

Description:

4.5cc 15% dextrose and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance

Treatment:

Procedure: 15% Dextrose

control group

Placebo Comparator group

Description:

4.5cc normal saline and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance

Treatment:

Procedure: Normal saline