Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease

• ClinicalTrials.gov Identifier: NCT01735058
• Recruitment Status: Unknown
• First Posted: November 28, 2012
• Last Update Posted: December 4, 2012
• Sponsor: Isfahan University of Medical Sciences
• Information provided by (Responsible Party): Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Subacromial Impingement Syndrome	Drug: Sodium Hyaluronate; Drug: Normal saline	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluating the Efficacy of Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in the Treatment of Rotator Cuff Disease
• Study Start Date: February 2012
• Estimated Primary Completion Date: December 2012
• Estimated Study Completion Date: December 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Sodium hyaluronate; Ultrasound guided injection of sodium hyaluronate	Drug: Sodium Hyaluronate; Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.
Placebo Comparator: Normal saline; Ultrasound guided injection of normal saline	Drug: Normal saline; Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in pain severity after 3 weeks. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Farnaz Dehghan, MD; dr.farnaz.dehghan@gmail.com

Locations

Iran, Islamic Republic of

Department of Rehabilitation, Alzahra Hospital; Recruiting

Isfahan, Iran, Islamic Republic of

Contact: Alireza Moghtaderi, MD moghtaderia@yahoo.com

Sub-Investigator: Alireza Moghtaderi, MD

Sponsors and Collaborators

Isfahan University of Medical Sciences

Investigators

• Principal Investigator: Farnaz Dehghan, MD; Isfahan University of Medical Sciences

More Information

Publications:

Andrews JR. Diagnosis and treatment of chronic painful shoulder: review of nonsurgical interventions. Arthroscopy. 2005 Mar;21(3):333-47. doi: 10.1016/j.arthro.2004.11.003.

Meloni F, Milia F, Cavazzuti M, Doria C, Lisai P, Profili S, Meloni GB. Clinical evaluation of sodium hyaluronate in the treatment of patients with sopraspinatus tendinosis under echographic guide: experimental study of periarticular injections. Eur J Radiol. 2008 Oct;68(1):170-3. doi: 10.1016/j.ejrad.2007.11.001. Epub 2007 Dec 21.

Kim YS, Park JY, Lee CS, Lee SJ. Does hyaluronate injection work in shoulder disease in early stage? A multicenter, randomized, single blind and open comparative clinical study. J Shoulder Elbow Surg. 2012 Jun;21(6):722-7. doi: 10.1016/j.jse.2011.11.009. Epub 2012 Feb 25.

Chou WY, Ko JY, Wang FS, Huang CC, Wong T, Wang CJ, Chang HE. Effect of sodium hyaluronate treatment on rotator cuff lesions without complete tears: a randomized, double-blind, placebo-controlled study. J Shoulder Elbow Surg. 2010 Jun;19(4):557-63. doi: 10.1016/j.jse.2009.08.006. Epub 2009 Dec 5.

• Responsible Party: Farnaz Dehgan Hosseinabadi, Principal Investigator, Isfahan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01735058
• Other Study ID Numbers: 13912134
• First Posted: November 28, 2012
• Last Update Posted: December 4, 2012
• Last Verified: December 2012

Additional relevant MeSH terms:

Shoulder Impingement Syndrome; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Hyaluronic Acid; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Viscosupplements; Protective Agents