Hyaluronic Acid, Subdeltoid Bursitis
Conditions
Keywords
Subdeltoid Bursitis, Hyaluronic acid, cross linked
Brief summary
This study aims to compare the efficacy of different structures of hyaluronic acid, namely cross-linked and non-cross-linked hyaluronic acid, in treating subdeltoid bursitis.
Detailed description
A double-blind, randomized clinical trial will be conducted to collect 52 patients with subdeltoid bursitis. The patients will be injected with cross-linked or non-cross-linked hyaluronic acid under ultrasound guidance. Before treatment, one week after treatment (i.e., one week after injection), one month after treatment, and three months after treatment to detect shoulder pain (visual analog scale; pressure ergometer to measure pain pressure threshold), function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) will be arranged.
Interventions
cross-linked hyaluronic acid injection with physical therapy
DRUGnon-cross-linked hyaluronic acid
non-cross-linked hyaluronic acid injection with physical therapy
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* clinical diagnosis of subdeltoid bursitis * age 20 or older 20 * at least one positive in the painful arc, neer test, or Hawkins test * can attend three months of intervention and follow-up
Exclusion criteria
* history of malignancy * previous shoulder operation or injury * previous shoulder injections in the past three months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain and disability index | score change from baseline to 1 week, 1 month and 3 months after treatment | measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the arm, shoulder, and hand | score change from baseline to 1 week, 1 month and 3 months after treatment | measure sports/music and work related to shoulder pain, ranges from 0-100, higher scores indicate more pain or disability |
| Visual analog scale | score change from baseline to 1 week, 1 month and 3 months after treatment | measure shoulder pain, ranges from 0-10, higher score indicate more pain |
| range of motion | score change from baseline to 1 week, 1 month and 3 months after treatment | measure shoulder range of motion, higher score indicate higher range of motion |
| Brief version of the World Health Organization Quality of Life Scale | score change from baseline to 1 week, 1 month and 3 months after treatment | measure quality of life, ranges from 0-100, higher scores indicate better quality of life |
Countries
Taiwan
Contacts
Primary ContactRu-Lan Hsieh, MD
Outcome results
None listed