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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

November 16, 2012
November 28, 2012
December 4, 2012
February 2012
December 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01735058 on ClinicalTrials.gov Archive Site
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Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease
Evaluating the Efficacy of Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in the Treatment of 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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Subacromial Impingement Syndrome
  • Drug: Sodium Hyaluronate
    Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.
  • Drug: Normal saline
    Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.
  • Active Comparator: Sodium hyaluronate
    Ultrasound guided injection of sodium hyaluronate
    Intervention: Drug: Sodium Hyaluronate
  • Placebo Comparator: Normal saline
    Ultrasound guided injection of normal saline
    Intervention: Drug: Normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
48
Same as current
December 2012
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT01735058
13912134
Yes
Not Provided
Not Provided
Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Not Provided
Principal Investigator: Farnaz Dehghan, MD Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP