NCT02592629

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 10, 2018

Completed
Last Updated

October 16, 2018

Status Verified

September 1, 2018

Enrollment Period

1.4 years

First QC Date

October 28, 2015

Results QC Date

June 20, 2018

Last Update Submit

September 17, 2018

Conditions

Shoulder Pain

Keywords

subacromial injectionrotator cuff diseasesteroid injection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

no topical or subcutaneous anesthetic

ACTIVE COMPARATOR

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

Drug: lidocaineDrug: Kenalog

subcutaneous lidocaine

ACTIVE COMPARATOR

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: lidocaineDrug: Kenalog

topical ethyl chloride

ACTIVE COMPARATOR

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

Drug: lidocaineDrug: ethyl chlorideDrug: Kenalog

Interventions

lidocaineDRUG

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

Also known as: xylocaine
no topical or subcutaneous anestheticsubcutaneous lidocainetopical ethyl chloride
ethyl chlorideDRUG

topical spray

Also known as: chloroethane
topical ethyl chloride
KenalogDRUG

used with lidocaine in shoulder injection

Also known as: triamcinolone
no topical or subcutaneous anestheticsubcutaneous lidocainetopical ethyl chloride

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hershey, Pennsylvania, 17019, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

LidocaineEthyl ChlorideTriamcinolone AcetonideTriamcinolone

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbonsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Robert Gallo, M.D.
Organization
Penn State Hershey Medical Center
rgallo@pennstatehershey.psu.edu
7175310003

Study Officials

  • Robert A Gallo, MD

    The Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery Orthopaedics

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 30, 2015

Study Start

February 1, 2016

Primary Completion

June 20, 2017

Study Completion

June 20, 2017

Last Updated

October 16, 2018

Results First Posted

September 10, 2018

Record last verified: 2018-09

Locations

US(1)