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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02592629
• Other study ID #: 2690
• Status: Terminated
• Phase: Phase 4
• Start date: February 1, 2016
• Est. completion date: June 20, 2017

Study information

• Verified date: September 2018
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: June 20, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Drug:
• lidocaine
used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection
• ethyl chloride
topical spray
• Kenalog
used with lidocaine in shoulder injection

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Assessment	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