Efficacy of Intra-articular NSAID Versus Corticosteroid i... | NCT03616340

Studies
Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study

NCT03616340

Sponsor

OSF Healthcare System

Status

Unknown status

Last Update Posted

Aug 6, 2018Actual

Enrollment

50Estimated

Phase

Phase 3

Conditions

Knee Arthritis
Shoulder Arthritis
Shoulder Impingement
Meniscus Lesion
Rotator Cuff Tear
Rotator Cuff Tear Arthropathy

Interventions

Shoulder injection
knee injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2018Estimated

Primary Completion Date

Aug 2019Estimated

Completion Date

Aug 2020Estimated

First Submitted Date

Jul 31, 2018

First Submission Date that Met QC Criteria

Aug 3, 2018

First Posted Date

Aug 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2018

Last Update Posted Date

Aug 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The proposed study will compare the efficacy of Triamcinolone versus Ketorolac for intra-articular injection of the knee and shoulder

Detailed Description

This study will be a randomized prospective study comparing Triamcinolone to Ketorolac for injections in the knee and shoulder for a variety of orthopedic conditions. The investigators will monitor pain relief, length of pain relief, cost, and patient satisfaction after the injections

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ketorolac	Experimental		Drug: Shoulder injection Drug: knee injection
Kenalog	Experimental		Drug: Shoulder injection Drug: knee injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Shoulder injection	Drug	intra articular or subacromial shoulder injection	Kenalog Ketorolac

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain level: VAS score	VAS score	0-6 months
length pain relief	length of time patient reports pain relief	0-6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

knee and shoulder arthritis
shoulder impingement
rotator cuff tear

Exclusion Criteria:

chronic pain management
allergy to NSAIDs or steroids
prior surgery
kidney disease that would preclude NSAID administration

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Miguel ramirez, MD	Contact	17857661273		maramirez09@gmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D019534	Shoulder Impingement Syndrome
D000070636	Rotator Cuff Injuries
D000070656	Rotator Cuff Tear Arthropathy

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070599	Shoulder Injuries
D014947	Wounds and Injuries
D012421	Rupture
D013708	Tendon Injuries
D002805	Chondrocalcinosis
D001168	Arthritis
D000070657	Crystal Arthropathies