NCT01735058

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 4, 2012

Status Verified

December 1, 2012

Enrollment Period

10 months

First QC Date

November 16, 2012

Last Update Submit

December 1, 2012

Conditions

Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 3 weeks

Study Arms (2)

Sodium hyaluronate

ACTIVE COMPARATOR

Ultrasound guided injection of sodium hyaluronate

Drug: Sodium Hyaluronate

Normal saline

PLACEBO COMPARATOR

Ultrasound guided injection of normal saline

Drug: Normal saline

Interventions

Sodium HyaluronateDRUG

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

Sodium hyaluronate
Normal salineDRUG

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

Normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \>= 18 years
  • subacromial impingement syndrome
  • without a complete tear of rotator cuff
  • willingness to participate

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation, Alzahra Hospital

Isfahan, Isfahan, Iran

RECRUITING

Related Publications (4)

  • 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.

    PMID: 15756189BACKGROUND

  • 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.

    PMID: 18096343BACKGROUND

  • 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.

    PMID: 22366365BACKGROUND

  • 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.

    PMID: 19963403BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Hyaluronic AcidSaline Solution

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Farnaz Dehghan, MD

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Farnaz Dehghan, MD

CONTACT

dr.farnaz.dehghan@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2012

First Posted

November 28, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 4, 2012

Record last verified: 2012-12

Locations

IR(1)