The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections

September 17, 2018 updated by: Robert A. Gallo, Milton S. Hershey Medical Center
The specific aim of this prospective study is to determine whether local anesthetics prior to subacromial steroid injections reduce pain and consequently if they are cost-effective in the treatment for shoulder pathology.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Shoulder pain is a common problem that can be estimated to be prevalent in up to 15 percent of the patient population registered to general practices and is second only to back pain in patients seeking treatment for musculoskeletal issues in the primary care setting. As a common source of distress, shoulder pain contributes significantly to health care costs.

Rotator cuff disease due to impingement, tendonitis or bursitis is a frequent cause of shoulder pain and dysfunction. Initial treatment consists of a conservative approach of activity modification, oral nonsteroidal anti-inflammatory drugs (NSAIDs) and supervised physical therapy. However, if the patients' symptoms persist, subacromial injections of a local anesthetic such as lidocaine, and a corticosteroid may be indicated as a sequential treatment option.

The steroid injection itself can be a painful process, so administering a local anesthetic prior to the steroid injection is thought to mitigate pain or reduce possible discomfort during and immediately following the procedure. Though there is evidence advocating for the benefits of combining local anesthetics and corticosteroids for the treatment of subacromial pathologies, it is not conclusive whether local anesthesia significantly enhances the pain relieving effect of steroids. Should local anesthesia not have a significant impact on the patient's pain intensity, then the use of corticosteroids alone could potentially result in reduced costs in care.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17019
        • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 18 to 70 years old
  • Shoulder pain lasting at least 4 weeks
  • Inability to use arm with restriction of movement and loss of full function.
  • Able to understand study and provide voluntary, written informed consent

Exclusion Criteria:

  • Less than 18 or greater than 70 years old
  • Contraindications of previous injections and previous shoulder surgery
  • Unable to understand consent form (in the opinion of the PI)
  • Non-English speaking individuals
  • Medication contradictions to lidocaine, corticosteroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: no topical or subcutaneous anesthetic
Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine
Drug: lidocaine
used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection
Other Names:
  • xylocaine
Drug: Kenalog
used with lidocaine in shoulder injection
Other Names:
  • triamcinolone
Active Comparator: subcutaneous lidocaine
Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection
Drug: lidocaine
used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection
Other Names:
  • xylocaine
Drug: Kenalog
used with lidocaine in shoulder injection
Other Names:
  • triamcinolone
Active Comparator: topical ethyl chloride
Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds
Drug: lidocaine
used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection
Other Names:
  • xylocaine
Drug: Kenalog
used with lidocaine in shoulder injection
Other Names:
  • triamcinolone
Drug: ethyl chloride
topical spray
Other Names:
  • chloroethane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Assessment
Time Frame: change from baseline assessment before injection at 10 minutes post injection
Pain assessed on a visual analog scale from 1 (no pain) to 10 (worst pain imaginable). Pain score at 10 minutes post-injection is subtracted from baseline pre-injection score. Positive numbers to represent increases and negative numbers to represent decreases.
change from baseline assessment before injection at 10 minutes post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Robert A Gallo, MD, The Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

June 20, 2017

Study Completion (Actual)

June 20, 2017

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2690

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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