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Comparison Between Subacromial Infiltrations

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ClinicalTrials.gov Identifier: NCT03303001
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

Brief Summary:
The shoulder pain is commonly seeing in orthopedic consultation. Many patients was affected in activities of daily living and in laborer absent. One of the first treatment lines is the steroid infiltration for pain relieve, however in several times is only effective by a short period of time, and the symptoms usually appear again. One of the not known infiltration is the high volumen infiltration in subacromial space, this treatment appears to be an effective treatment for this patients.

Condition or disease Intervention/treatment Phase
Subacromial Bursitis Subacromial Impingement Syndrome Rotator Cuff Impingement Syndrome Procedure: Subacromial high volume infiltration Procedure: Subacromial conventional infiltration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Subacromial Injection of High Volume Versus Conventional Steroid Injection Guided by Ultrasound in Shoulder Pain. Randomized Controlled Trial
Actual Study Start Date : September 26, 2017
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : April 30, 2020

Arm Intervention/treatment
Experimental: Subacromial high volume infiltration
This group received an subacromial infiltration guided by ultrasound, of 50 mL of solution. This solution mix: 2 mL of methylprednisolone (40 mg) plus 8 mL of lidocaine simple plus 10 mL of ropivacaine 7.5% plus 30 mL of saline solution.
Procedure: Subacromial high volume infiltration
This group will receive a high volume dose of a mix of methylprednisolone (40 mg in 2 mL) plus ropivacaine at 7.5% plus simple lidocaine plus saline solution for a total of 50 mL
Other Name: subacromial infiltration

Active Comparator: Subacromial conventional infiltration
This group received an subacromial infiltration guided by ultrasound of 10 mL of solution. This solution mix: 2 mL of methylprednisolone (40 mg) plus 3 mL of lidocaine simple plus 5 mL of ropivacaine 7.5%
Procedure: Subacromial conventional infiltration
This group will receive a mix of solution of 2 mL of 40 mg of methylprednisolone plus 5 ml of ropivacaine at 7.5% plus 3 mL of lidocaine simple for a total of 10 ml
Other Name: subacromial infiltration




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: Three months ]
    Measure the pain in patient, when 0 is no pain and 10 worst pain


Secondary Outcome Measures :
  1. Shoulder Pain and Disability Index (SPADI) [ Time Frame: Three months ]
    Evaluates pain and function in 13 questions, with a scale from 0 to 10, normal shoulder is 0 and worst is 130

  2. Simple Shoulder Test (SST) [ Time Frame: Three months ]
    Twelve questions based on pain, function and range of motion, when 0 is an affected shoulder and 12 in a normal shoulder



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Shoulder impingement syndrome
  • Three months of history of pain and disability of the shoulder
  • Failure to conservative initial treatment with NSAID's and rehabilitation

Exclusion Criteria:

  • Rotator cuff tears
  • Previous shoulder surgeries of any kind
  • Glenohumeral or acromioclavicular arthritis
  • Metabolic disease like diabetes mellitus or rheumatoid arthritis
  • Previous infiltration in the past sixth months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303001


Locations
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Mexico
Universidad Autonoma de Nuevo Leon
Monterrey, Nuevo Leon, Mexico, 64480
Universidad Autonoma de Nuevo Leon
Monterrey, Nuevo Leon, Mexico, 66460
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Principal Investigator: Carlos Acosta-Olivo, MD, PhD Universidad Autonoma de Nuevo Leon
Publications of Results:
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Responsible Party: Carlos A Acosta-Olivo, Professor, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT03303001    
Other Study ID Numbers: OR17-00006
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Actually is an active study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon:
subacromial infiltration
high volumen
shoulder pain
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Bursitis
Syndrome
Rotator Cuff Injuries
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries