Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease

• Sponsor: Isfahan University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01735058
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 4.8

Study Details

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
• Anticipated 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: Feb 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Dec 1, 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. [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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Rehabilitation, Alzahra Hospital	Isfahan		Iran, Islamic Republic of

Sponsors and Collaborators

• Isfahan University of Medical Sciences

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Andrews JR. Diagnosis and treatment of chronic painful shoulder: review of nonsurgical interventions. Arthroscopy. 2005 Mar;21(3):333-47. Review.
• 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.
• 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.
• 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. Epub 2007 Dec 21.

• Responsible Party: Farnaz Dehgan Hosseinabadi, Principal Investigator, Isfahan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT01735058
• Other Study ID Numbers: 13912134
• First Posted: Nov 28, 2012
• Last Update Posted: Dec 4, 2012
• Last Verified: Dec 1, 2012

• Additional relevant MeSH terms: Shoulder Impingement Syndrome; Hyaluronic Acid

Study Results

No Results Posted as of Dec 4, 2012