Clinical trial NCT03447158: Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis
Official title: Effects of Hyperosmolar Dextrose Injection in Rotator Cuff Disorder With Bursitis : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Bursitis
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy
timeFrame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Secondary outcomes:
measure: Change from Baseline shoulder joint active range of motion (PROM) at 1 week, 1 month, and 3 months after 3rd section of therapy
timeFrame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
measure: Change from Baseline Shoulder Pain and Disability Index (SPADI) score at 1 week, 1 month, and 3 months after 3rd section of therapy
timeFrame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
measure: Change from Baseline Ultrasound property at 1 week, 1 month, and 3 months after 3rd section of therapy
timeFrame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
measure: Change from Baseline pain on resting at 1 week, 1 month, and 3 months after 3rd section of therapy
timeFrame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
Study officials:
References:
citation: Chang YJ, Chang FH, Hou PH, Tseng KH, Lin YN. Effects of Hyperosmolar Dextrose Injection in Patients With Rotator Cuff Disease and Bursitis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Feb;102(2):245-250. doi: 10.1016/j.apmr.2020.08.010. Epub 2020 Sep 11.