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

NCT ID: NCT02592629

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2017-06-20

Brief Summary

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.

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

no topical or subcutaneous anesthetic

Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine

Group Type: ACTIVE_COMPARATOR

lidocaine

Intervention Type: DRUG

used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection

Kenalog

Intervention Type: DRUG

used with lidocaine in shoulder injection

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

Group Type: ACTIVE_COMPARATOR

lidocaine

Intervention Type: DRUG

used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection

Kenalog

Intervention Type: DRUG

used with lidocaine in shoulder injection

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

Group Type: ACTIVE_COMPARATOR

lidocaine

Intervention Type: DRUG

used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection

ethyl chloride

Intervention Type: DRUG

topical spray

Kenalog

Intervention Type: DRUG

used with lidocaine in shoulder injection

Interventions

lidocaine

used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection

Intervention Type: DRUG

ethyl chloride

topical spray

Intervention Type: DRUG

Kenalog

used with lidocaine in shoulder injection

Intervention Type: DRUG

Other Intervention Names

xylocaine; chloroethane; triamcinolone

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Robert A. Gallo

Assistant Professor of Surgery Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert A Gallo, MD

Role: PRINCIPAL_INVESTIGATOR

The Milton S. Hershey Medical Center

Locations

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2690

Identifier Type: -

Identifier Source: org_study_id