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Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease

NCT ID: NCT01735058

Last Updated: 2012-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Subacromial Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sodium hyaluronate

Ultrasound guided injection of sodium hyaluronate

Group Type ACTIVE_COMPARATOR

Sodium Hyaluronate

Intervention Type DRUG

Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.

Normal saline

Ultrasound guided injection of normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.

Interventions

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Sodium Hyaluronate

Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.

Intervention Type DRUG

Normal saline

Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Farnaz Dehgan Hosseinabadi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Farnaz Dehghan, MD

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

Locations

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Department of Rehabilitation, Alzahra Hospital

Isfahan, Isfahan, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Farnaz Dehghan, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Alireza Moghtaderi, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 15756189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18096343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22366365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19963403 (View on PubMed)

Other Identifiers

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13912134

Identifier Type: -

Identifier Source: org_study_id