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

Primary Purpose

Shoulder Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lidocaine
ethyl chloride
Kenalog
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring subacromial injection, rotator cuff disease, steroid injection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

no topical or subcutaneous anesthetic

subcutaneous lidocaine

topical ethyl chloride

Arm Description

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

Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2015
Last Updated
September 17, 2018
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02592629
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of time to enroll due to additional responsibilities of the PI and research coordinator.
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
June 20, 2017 (Actual)
Study Completion Date
June 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
subacromial injection, rotator cuff disease, steroid injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no topical or subcutaneous anesthetic
Arm Type
Active Comparator
Arm Description
Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine
Arm Title
subcutaneous lidocaine
Arm Type
Active Comparator
Arm 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
Arm Title
topical ethyl chloride
Arm Type
Active Comparator
Arm Description
Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds
Intervention Type
Drug
Intervention Name(s)
lidocaine
Other Intervention Name(s)
xylocaine
Intervention Description
used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
ethyl chloride
Other Intervention Name(s)
chloroethane
Intervention Description
topical spray
Intervention Type
Drug
Intervention Name(s)
Kenalog
Other Intervention Name(s)
triamcinolone
Intervention Description
used with lidocaine in shoulder injection
Primary Outcome Measure Information:
Title
Change in Pain Assessment
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 decreases.
Time Frame
change from baseline assessment before injection at 10 minutes post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Gallo, MD
Organizational Affiliation
The Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17019
Country
United States

12. IPD Sharing Statement

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

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