Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease

Isfahan University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Subacromial Impingement Syndrome

Treatments: Drug: Sodium Hyaluronate; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01735058

13912134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Sodium hyaluronate

Active Comparator group

Description:

Ultrasound guided injection of sodium hyaluronate

Treatment:

Drug: Sodium Hyaluronate

Normal saline

Placebo Comparator group

Description:

Ultrasound guided injection of normal saline

Treatment:

Drug: Normal saline