Knee Injections for Obese Patients With Knee Arthritis
ConditionOsteoarthritis of Knee
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age55-85
SponsorMayo Clinic
About this trial
The purpose of this study is to assess obese patients with knee arthritis and determine the non-inferiority of a low dose steroid treatment vs. standard dose steroid treatment for two knee outcome measures: pain and function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
BMI < 30 kg/m2
Uncontrolled diabetics with a hemoglobin A1c > 8%
No other treatment within the time frame of the study.
Patients that are undergoing physical therapy at the time of the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Triamcinolone Acetonide Low Dose
DrugSubjects will receive a reduced dose of 20mg of triamcinolone acetonide. Total injection volume of 5ml, consisting of: * 0.5ml triamcinolone acetonide (20mg) * 4.5ml lidocaine (45mg)
Triamcinolone Acetonide Standard Dose
DrugSubjects will receive the standard of care dose of 40mg triamcinolone acetonide Total injection volume of 5ml, consisting of: * 1ml triamcinolone acetonide (40mg) * 4ml lidocaine (40mg)
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Standard Dose GroupActive comparator 1 intervention
Group B: Lower Dose GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Numerical Pain Scale (NPS)
The Numerical Pain Scale (NPS) uses a 0-10 point rating system in which the patient selects the number that describes their current pain level, where "0" represents "no pain" and "10" represents "the worst pain imaginable"
Time frame
Baseline, 4 weeks, 12 weeks2
Knee Injury and Osteoarthritis Outcome score (KOOS)
The Knee Injury and Osteoarthritis Outcome is a commonly used questionnaire which focuses on how patients are affected by osteoarthritis symptoms in five areas: knee pain, stiffness, daily activity, sport and recreation, and quality of life. Results are scored 0-100. 0 = extreme problems, 100 = no problems.
Time frame
Baseline, 4 weeks, 12 weeksSponsors and contacts
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Source ClinicalTrials.gov