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Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome

This study has been completed.
Sponsor:
Collaborators:
University of Puget Sound
Franklin Pierce University
Information provided by (Responsible Party):
Dan Rhon, Madigan Army Medical Center
ClinicalTrials.gov Identifier:
NCT01190891
First received: June 9, 2010
Last updated: March 28, 2016
Last verified: March 2016
Results First Received: October 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Shoulder Impingement Syndrome
Interventions: Procedure: Manual Physical Therapy
Procedure: Corticosteroid Injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Manual Physical Therapy

The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.

Manual Physical Therapy: Same as arm description

Corticosteroid Injection (Subacromial)

Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL

Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).


Participant Flow:   Overall Study
    Manual Physical Therapy   Corticosteroid Injection (Subacromial)
STARTED   52   52 
COMPLETED   46   52 
NOT COMPLETED   6   0 
Protocol Violation                1                0 
Withdrawal by Subject                5                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Manual Physical Therapy Manual Physical Therapy: Same as arm description
Corticosteroid Injection (Subacromial)

Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL

Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).

Total Total of all reporting groups

Baseline Measures
   Manual Physical Therapy   Corticosteroid Injection (Subacromial)   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   52   98 
Age 
[Units: Years]
Mean (Standard Deviation)
 40  (12)   42  (12)   41  (12) 
Gender 
[Units: Participants]
     
Female   17   14   31 
Male   29   38   67 
Region of Enrollment 
[Units: Participants]
     
United States   46   52   98 


  Outcome Measures
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1.  Primary:   Shoulder Pain and Disability Index   [ Time Frame: 1 year ]

2.  Secondary:   Global Rating of Change   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Troy Patience, Research Operations Service
Organization: Madigan Army Medical Center
phone: (253) 968-1160
e-mail: usarmy.jblm.medcom-mamc.mbx.dci@mail.mil


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dan Rhon, Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT01190891     History of Changes
Other Study ID Numbers: 111411-1
Study First Received: June 9, 2010
Results First Received: October 14, 2015
Last Updated: March 28, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board