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
|Condition or disease||Intervention/treatment||Phase|
|Subacromial Impingement Syndrome||Drug: Sodium Hyaluronate Drug: Normal saline||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
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
|Contact: Farnaz Dehghan, MDfirstname.lastname@example.org|
|Iran, Islamic Republic of|
|Department of Rehabilitation, Alzahra Hospital||Recruiting|
|Isfahan, Iran, Islamic Republic of|
|Contact: Alireza Moghtaderi, MD email@example.com|
|Sub-Investigator: Alireza Moghtaderi, MD|
|Principal Investigator:||Farnaz Dehghan, MD||Isfahan University of Medical Sciences|