Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease
Primary Purpose
Subacromial Impingement Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Sodium Hyaluronate
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Subacromial Impingement Syndrome
Eligibility 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.
Sites / Locations
- Department of Rehabilitation, Alzahra HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sodium hyaluronate
Normal saline
Arm Description
Ultrasound guided injection of sodium hyaluronate
Ultrasound guided injection of normal saline
Outcomes
Primary Outcome Measures
Change from baseline in pain severity after 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01735058
First Posted
November 16, 2012
Last Updated
December 1, 2012
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01735058
Brief Title
Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease
Official Title
Evaluating the Efficacy of Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in the Treatment of Rotator Cuff Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sodium hyaluronate
Arm Type
Active Comparator
Arm Description
Ultrasound guided injection of sodium hyaluronate
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Ultrasound guided injection of normal saline
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate
Intervention Description
Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.
Primary Outcome Measure Information:
Title
Change from baseline in pain severity after 3 weeks.
Description
The pain score (100 mm Visual Analogue Score ) is evaluated before the first injection and one week after each injection up to 3rd week.
Time Frame
Up to 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farnaz Dehghan, MD
Email
dr.farnaz.dehghan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farnaz Dehghan, MD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation, Alzahra Hospital
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alireza Moghtaderi, MD
Email
moghtaderia@yahoo.com
First Name & Middle Initial & Last Name & Degree
Alireza Moghtaderi, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
15756189
Citation
Andrews JR. Diagnosis and treatment of chronic painful shoulder: review of nonsurgical interventions. Arthroscopy. 2005 Mar;21(3):333-47. doi: 10.1016/j.arthro.2004.11.003.
Results Reference
background
PubMed Identifier
18096343
Citation
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. doi: 10.1016/j.ejrad.2007.11.001. Epub 2007 Dec 21.
Results Reference
background
PubMed Identifier
22366365
Citation
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.
Results Reference
background
PubMed Identifier
19963403
Citation
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.
Results Reference
background
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Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease
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