Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease

This study is currently recruiting participants.
Verified December 2012 by Isfahan University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01735058
First received: November 16, 2012
Last updated: December 1, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Subacromial Impingement Syndrome
Drug: Sodium Hyaluronate
Drug: Normal saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Change from baseline in pain severity after 3 weeks. [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: No ]
    The pain score (100 mm Visual Analogue Score ) is evaluated before the first injection and one week after each injection up to 3rd week.


Estimated Enrollment: 48
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: November 16, 2012
Last Updated: December 1, 2012
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014