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

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02592629
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 3
• Actual Duration (Months): 16.6
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain	Drug: lidocaine; Drug: ethyl chloride; Drug: Kenalog	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Jun 20, 2017
• Actual Study Completion Date: Jun 20, 2017

Arms and Interventions

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: ethyl chloride; topical spray; Other Names: chloroethane ; Drug: Kenalog; used with lidocaine in shoulder injection; Other Names: triamcinolone

Outcome Measures

Primary Outcome Measures

1. Change in Pain Assessment [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17019

Sponsors and Collaborators

• Milton S. Hershey Medical Center

Investigators

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

Study Documents (Full-Text)

• Informed Consent Form - Feb 8, 2016
• Study Protocol and Statistical Analysis Plan - Feb 8, 2016

More Information

Publications

None provided.

• Responsible Party: Robert A. Gallo, Assistant Professor of Surgery Orthopaedics, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02592629
• Other Study ID Numbers: 2690
• First Posted: Oct 30, 2015
• Last Update Posted: Oct 16, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by Robert A. Gallo, Assistant Professor of Surgery Orthopaedics, Milton S. Hershey Medical Center: subacromial injection; rotator cuff disease; steroid injection
• Additional relevant MeSH terms: Shoulder Pain; Triamcinolone; Triamcinolone Acetonide; Lidocaine; Ethyl Chloride

Study Results

Participant Flow

Arm/Group Title	no Topical or Subcutaneous Anesthetic	Subcutaneous Lidocaine	Topical Ethyl Chloride
Arm/Group Description	Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds 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
Period Title: Overall Study
STARTED	5	9	5
COMPLETED	5	9	5
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	no Topical or Subcutaneous Anesthetic	Subcutaneous Lidocaine	Topical Ethyl Chloride	Total
Arm/Group Description	Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds 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	Total of all reporting groups
Overall Participants	5	9	5	19
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	5 100%	9 100%	5 100%	19 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	3 60%	7 77.8%	2 40%	12 63.2%
Male	2 40%	2 22.2%	3 60%	7 36.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	5 100%	9 100%	5 100%	19 100%
baseline pain (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.2 (2.56)	5.16 (1.93)	4.7 (1.84)	4.78 (2.11)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	no Topical or Subcutaneous Anesthetic	Subcutaneous Lidocaine	Topical Ethyl Chloride
Arm/Group Description	Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds 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
Measure Participants	5	9	5
Mean (Standard Deviation) [units on a scale]	3 (1.6)	4.21 (2.19)	5.6 (1.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	no Topical or Subcutaneous Anesthetic, Subcutaneous Lidocaine, Topical Ethyl Chloride
	Comments
	Type of Statistical Test	Equivalence
	Comments	ANOVA
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	3 months
Arm/Group Title	no Topical or Subcutaneous Anesthetic		Subcutaneous Lidocaine		Topical Ethyl Chloride
Arm/Group Description	Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection		Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection		Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds 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
All Cause Mortality
	no Topical or Subcutaneous Anesthetic		Subcutaneous Lidocaine		Topical Ethyl Chloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/9 (0%)		0/5 (0%)
Serious Adverse Events
	no Topical or Subcutaneous Anesthetic		Subcutaneous Lidocaine		Topical Ethyl Chloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/9 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	no Topical or Subcutaneous Anesthetic		Subcutaneous Lidocaine		Topical Ethyl Chloride
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/9 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.