Subacromial Impingement Syndrome
Conditions
Brief summary
This study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.
Detailed description
Rotator cuff disease in particular is a common cause of shoulder pain and weakness and comprises a significant proportion of the musculoskeletal complaints presenting to primary care doctors. Ultrasound is a readily available and cheap modality for looking more specifically at the rotator cuff and surrounding structures. More recently, ultrasound guidance has become a commonly employed method to perform diagnostic or therapeutic interventions. Despite the long history and the fact that this is a common diagnosis made in clinical practice, the exact cause and best treatment for this condition still are being explored. Although there are a few high-quality studies demonstrating the efficacy of sodium hyaluronate injection for rotator cuff disease, this study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.
Interventions
DRUGSodium Hyaluronate
Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.
DRUGNormal saline
Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>= 18 years * subacromial impingement syndrome * without a complete tear of rotator cuff * willingness to participate
Exclusion criteria
* had any rheumatic disease, glenohumeral osteoarthritis, full-thickness rotator cuff tears, fractures, diabetes mellitus, infections, or tumors. * had hypersensitivity to hyaluronate * had participated in any other study within 6 months * had received a subacromial injection within 8 weeks * were pregnant or planned to become pregnant * were at risk of complications of intra-articular injections such as patients who received anti-coagulant drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pain severity after 3 weeks. | Up to 3 weeks | The pain score (100 mm Visual Analogue Score ) is evaluated before the first injection and one week after each injection up to 3rd week. |
Countries
Iran
Contacts
Primary ContactFarnaz Dehghan, MD
Outcome results
None listed