Actively Recruiting

Phase 4
Age: 55Years - 85Years
All Genders
ID06782529

Comparison of Varying Doses of Steroid for Intra-articular Knee Injections in Obese Patients With Knee Osteoarthritis

Led by Mayo Clinic · Updated on 2026-03-10

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating obese patients with knee arthritis to compare the effects of low dose versus standard dose steroid treatments delivered by knee injections. This study aims to determine if a reduced steroid dose is not worse than the standard dose in improving pain and knee function. The study is conducted by Mayo Clinic and is a Phase 4 interventional trial focused on knee osteoarthritis in patients aged 55 to 85 years with obesity. Participants will receive intra-articular injections in the knee with either a low dose or standard dose of the steroid triamcinolone acetonide. The low dose group receives 20 mg of triamcinolone mixed with lidocaine, making a total injection volume of 5 ml. The standard dose group receives 40 mg of triamcinolone with lidocaine, also totaling 5 ml. Both groups are interested in steroid injections for knee arthritis, and the study does not involve randomization or masking. During the study, participants will be assessed at baseline, 4 weeks, and 12 weeks after the injection. Pain will be measured using the Numerical Pain Scale (NPS), and knee function will be evaluated with the Knee Injury and Osteoarthritis Outcome Score (KOOS). These assessments will help researchers understand the impact of each dose on pain and function over time. The study excludes patients with uncontrolled diabetes, those currently undergoing physical therapy, or those who had other treatments during the study period. The total participation duration spans at least 12 weeks with scheduled evaluations.

CONDITIONS

Brief Title

Knee Injections for Obese Patients With Knee Arthritis

Who Can Participate

Age: 55Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with BMI 230 kg/m2 and radiograph-proven knee osteoarthritis who are interested in receiving a steroid injection for knee arthritis.
  • Age between 55 and 85 years.
  • Interested in knee intra-articular corticosteroid injections.
Not Eligible

You will not qualify if you...

  • BMI less than 30 kg/m2.
  • Uncontrolled diabetes with a hemoglobin A1c greater than 8%.
  • No other treatment within the time frame of the study.
  • Patients currently undergoing physical therapy at the time of the study.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 12 weeks

Participants receive a single intra-articular knee injection of either a low dose or standard dose of triamcinolone acetonide.

1 baseline visit and 2 follow-up visits (at 4 weeks and 12 weeks)

Trial Site Locations

Total: 1 location

1

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224

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Research Team

J

Jeffrey P Nadwodny, DO

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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