Do Knee Injections Offer Benefit With Knee Arthritis Pain

NCT04017949 | Completed FDA Drug

• 1 other identifier: STUDY19050002
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Corticosteroid and viscosupplementation injections have been used for years to treat osteoarthritic pain in knees. Recent studies have varied in reporting the effectiveness with these injections. None have been found to analyze pain scores between the groups though. This study aims to evaluate the effectiveness of corticosteroid injection (a single injection of 1 cc of 40 mg kenalog: 4 cc 0.5% Naropin) and viscosupplementation injection (Euflexxa and Synvisc, both are 2 cc of the medication given in 3 injections over a 3 week period). This will be analyzed with a modified visual analog scale over a period of time. An initial VAS will be collected prior to the first injection in the clinic. With the viscosupplementation injections, a VAS will be collected prior to injections 2 and 3 as well. These VAS are logged in the patient's chart. For both types of injections, the participant will be called and a VAS will be recorded 6 weeks post injection and 3 month post injection. These VAS will NOT be logged in the participant's chart. All VAS will be collected/recorded by the principal investigator. Statistical analysis will be conducted with a paired t-test (p\<0.05 with a confidence interval at 95%) from the pre-injection VAS and VAS subsequently.

Conditions

Knee Osteoarthritis

Keywords

viscosupplementation injection; corticosteroid injection

Outcome Measures

Primary Outcomes (1)

• Change from baseline in visual analog score at 3 months

  The primary endpoint is significant improvement in visual analog scores for corticosteroid vs viscosupplementation injections pre- and post-injections. VAS scores range from 0-10, 0 being no pain, 10 being the worst pain imaginable. The hypothesis is the injections will help reduce the participant's perception of pain, resulting in lower VAS scores. If the power size is valid, VAS will be compared between males/females.

  3 months

Interventions

Corticosteroid injection DRUG

1 cc (40 mg) of a corticosteroid (kenalog) is given

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited at their office visit scheduled with the principal investigator. Prior to the office visit, one of the surgeons diagnosed the potential subject with knee osteoarthritis. They recommended proceeding with a particular knee injection based upon previous treatments and insurance authorization. The determination of which injection is administered is not being determined by the study need.

You may qualify if:

• The participant has been previously been diagnosed with knee osteoarthritis by one of the investigator's surgeons in the office.
• The injection was recommended by another clinician
• Age of the pool of participants will be 40 years old and over
• All gender and BMI will be considered
• Severity of osteoarthritis will not be a determinant

You may not qualify if:

• Patients who are receiving any injections based upon medical recommendation by the primary investigator will be excluded from the study.
• Patients previously diagnosed with rheumatoid arthritis will be excluded from the study

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Three Rivers Orthopedic Associates

Pittsburgh, Pennsylvania, 15215, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• William J Vascik, MPAS, PA-C

  Senior Physician Assistant

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician Assistant

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: August 21, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)