Expired Study
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Hershey, Pennsylvania 17019


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

2690


NCT ID:

NCT02592629


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Milton S. Hershey Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Lack of time to enroll due to additional res


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

19


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:February 1, 2016
Completion Date:June 20, 2017
Completion Type:Actual
Primary Completion Date:June 20, 2017
Primary Completion Type:Actual
Verification Date:September 2018
Last Changed Date:September 17, 2018
First Received Date:October 28, 2015
First Results Date:June 20, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in Pain Assessment
Time Frame:change from baseline assessment before injection at 10 minutes post injection
Safety Issues:False
Description: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 decre

Study Interventions

Intervention Type:Drug
Name:lidocaine
Description:used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection
Arm Name:no topical or subcutaneous anesthetic
Other Name:xylocaine
Intervention Type:Drug
Name:ethyl chloride
Description:topical spray
Arm Name:topical ethyl chloride
Other Name:chloroethane
Intervention Type:Drug
Name:Kenalog
Description:used with lidocaine in shoulder injection
Arm Name:no topical or subcutaneous anesthetic
Other Name:triamcinolone

Study Arms

Study Arm Type:Active Comparator
Arm Name:topical ethyl chloride
Description:Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds
Study Arm Type:Active Comparator
Arm Name:subcutaneous lidocaine
Description:Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection
Study Arm Type:Active Comparator
Arm Name:no topical or subcutaneous anesthetic
Description:Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Milton S. Hershey Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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