Effects of Hyperosmolar Dextrose Injection in Rotator Cuff Disorder With Bursitis : A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mackay Memorial Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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)