Subacromial Bursitis
Conditions
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.
Interventions
PROCEDURE15% Dextrose
inject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance
PROCEDURENormal saline
inject normal saline and xylocaine into subacrominal bursa under sonographically guidance
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Countries
Taiwan
Outcome results
None listed