Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease

Phase 2

• Conditions: Subacromial Impingement Syndrome
• Interventions: Drug: Normal saline; Drug: Sodium Hyaluronate

• Registration Number: NCT01735058
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-22
• Study First Posted: 2012-11-28
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-01
• Last Update Posted: 2012-12-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal saline	Ultrasound guided injection of normal saline
Sodium hyaluronate	Sodium Hyaluronate	Ultrasound guided injection of sodium hyaluronate

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Rehabilitation, Alzahra Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of