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NCT04017949 · ClinicalTrials.gov registry record

Do Knee Injections Offer Benefit With Knee Arthritis Pain

A clinical trial, sponsored by University of Pittsburgh.

Completed
Registry status
75
Enrollment target

NCT04017949: Completed study, sponsored by University of Pittsburgh.

NCT04017949 is a clinical trial that has completed, run by University of Pittsburgh. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04017949 has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
75 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Corticosteroid injection

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2019-08-21
Est. Completion 2020-03-01
University of Pittsburgh

1,238 total trials

What the finished NCT04017949 record still lists

NCT04017949 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Corticosteroid injection is the first listed.

NCT04017949 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04017949 about?

NCT04017949 is a clinical study titled "Do Knee Injections Offer Benefit With Knee Arthritis Pain". 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 ...

What is the current status of trial NCT04017949?

This trial is currently completed. The enrollment target is 75 participants. The study started on 2019-08-21. Estimated completion is 2020-03-01.

What interventions are being tested in trial NCT04017949?

The interventions under investigation include: Corticosteroid injection (DRUG).

Who is sponsoring clinical trial NCT04017949?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04017949, the US trial registry maintained by the National Library of Medicine. NCT04017949 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.