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

• Sponsor: OSF Healthcare System (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03616340
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Knee Arthritis; Shoulder Arthritis; Shoulder Impingement; Meniscus Lesion; Rotator Cuff Tear; Rotator Cuff Tear Arthropathy	Drug: Shoulder injection; Drug: knee injection	Phase 3

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study
• Anticipated Study Start Date: Aug 1, 2018
• Anticipated Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketorolac	Drug: Shoulder injection; intra articular or subacromial shoulder injection; Drug: knee injection; intra-articular knee injection
Experimental: Kenalog	Drug: Shoulder injection; intra articular or subacromial shoulder injection; Drug: knee injection; intra-articular knee injection

Outcome Measures

Primary Outcome Measures

1. Pain level: VAS score [0-6 months]

   VAS score

2. length pain relief [0-6 months]

   length of time patient reports pain relief

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• OSF Healthcare System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Miguel Ramirez, Orthopaedic Surgeon, OSF Healthcare System
• ClinicalTrials.gov Identifier: NCT03616340
• Other Study ID Numbers: 1209087-1
• First Posted: Aug 6, 2018
• Last Update Posted: Aug 6, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Arthritis; Shoulder Impingement Syndrome; Rotator Cuff Tear Arthropathy; Rotator Cuff Injuries

Study Results

No Results Posted as of Aug 6, 2018