Comparison Between Subacromial Infiltrations

NCT03303001 | Completed DMC

• 1 other identifier: OR17-00006
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Subacromial Bursitis; Subacromial Impingement Syndrome; Rotator Cuff Impingement Syndrome

Keywords

subacromial infiltration; high volumen; shoulder pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale

  Measure the pain in patient, when 0 is no pain and 10 worst pain

  Three months

Secondary Outcomes (2)

• Shoulder Pain and Disability Index (SPADI)

  Three months

• Simple Shoulder Test (SST)

  Three months

Study Arms (2)

Subacromial high volume infiltration

EXPERIMENTAL

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

Subacromial conventional infiltration

ACTIVE COMPARATOR

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

Interventions

Subacromial high volume infiltration PROCEDURE

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

Also known as: subacromial infiltration

Subacromial high volume infiltration

Subacromial conventional infiltration PROCEDURE

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

Also known as: subacromial infiltration

Subacromial conventional infiltration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (2)

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 64480, Mexico

Location

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 66460, Mexico

Location

Related Publications (8)

• Morton S, Chan O, Ghozlan A, Price J, Perry J, Morrissey D. High volume image guided injections and structured rehabilitation in shoulder impingement syndrome: a retrospective study. Muscles Ligaments Tendons J. 2015 Oct 20;5(3):195-9. doi: 10.11138/mltj/2015.5.3.195. eCollection 2015 Jul-Sep.

  PMID: 26605194 RESULT

• Rossi F. Shoulder impingement syndromes. Eur J Radiol. 1998 May;27 Suppl 1:S42-8. doi: 10.1016/s0720-048x(98)00042-4.

  PMID: 9652501 RESULT

• Koester MC, George MS, Kuhn JE. Shoulder impingement syndrome. Am J Med. 2005 May;118(5):452-5. doi: 10.1016/j.amjmed.2005.01.040.

  PMID: 15866244 RESULT

• Chard MD, Sattelle LM, Hazleman BL. The long-term outcome of rotator cuff tendinitis--a review study. Br J Rheumatol. 1988 Oct;27(5):385-9. doi: 10.1093/rheumatology/27.5.385.

  PMID: 3179628 RESULT

• Green S, Buchbinder R, Hetrick S. Physiotherapy interventions for shoulder pain. Cochrane Database Syst Rev. 2003;2003(2):CD004258. doi: 10.1002/14651858.CD004258.

  PMID: 12804509 RESULT

• Buchbinder R, Green S, Youd JM. Corticosteroid injections for shoulder pain. Cochrane Database Syst Rev. 2003;2003(1):CD004016. doi: 10.1002/14651858.CD004016.

  PMID: 12535501 RESULT

• Petri M, Dobrow R, Neiman R, Whiting-O'Keefe Q, Seaman WE. Randomized, double-blind, placebo-controlled study of the treatment of the painful shoulder. Arthritis Rheum. 1987 Sep;30(9):1040-5. doi: 10.1002/art.1780300911.

  PMID: 3311051 RESULT

• Wheeler PC, Mahadevan D, Bhatt R, Bhatia M. A Comparison of Two Different High-Volume Image-Guided Injection Procedures for Patients With Chronic Noninsertional Achilles Tendinopathy: A Pragmatic Retrospective Cohort Study. J Foot Ankle Surg. 2016 Sep-Oct;55(5):976-9. doi: 10.1053/j.jfas.2016.04.017. Epub 2016 Jun 7.

  PMID: 27286927 RESULT

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Acosta-Olivo, MD, PhD

  Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2017
• First Posted: October 5, 2017
• Study Start: October 10, 2017
• Primary Completion: March 30, 2020
• Study Completion: April 30, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Locations

ME (2)