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Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease

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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

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.



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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735058


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

Publications:
Responsible Party: Farnaz Dehgan Hosseinabadi, Principal Investigator, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01735058     History of Changes
Other Study ID Numbers: 13912134
First Posted: November 28, 2012    Key Record Dates
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