Clinical trial NCT06703970: Platelet Rich Plasma Versus Corticosteroids in Knee Osteoarthritis Pain
Official title: The Efficacy of Platelet Rich Plasma Compared with Corticosteroid Injections for the Treatment of Pain Associated with Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis (OA)
Keywords: platelet rich plasma
knee OA
PRP
corticosteroids
osteoarthritis
knee osteoarthritis
Lead sponsor: LifeBridge Health
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center, randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.

Detailed description: Platelet rich plasma has become increasingly utilized as a treatment option for knee osteoarthritis. Corticosteroids is currently an approved medication to treat the symptoms of the knee osteoarthritis. There is limited evidence in a prospective randomized manner powered adequately to determine a difference between these treatments for pain associated with knee osteoarthritis.

Prospective, multi-center, single blind (participant), randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 21-80 years
* Radiographic diagnosis of Kellgren-Lawrence (KL) grade of II or III knee osteoarthritis
* Indicated for a knee injection to treat knee OA symptoms

Exclusion Criteria:

* Any injections into the target knee within three months
* Current overlying skin infection
* Current or previous diagnosis of "chronic pain"
* Opioid tolerant at time of screening (for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.)
* Allergy to any potential ingredients or medications utilized in any of the two groups
* Treatment with another investigational drug or other intervention for pain
* Diagnosis of Diabetes Mellitus
* If female, pregnant or planning to be pregnant within the following 3 months or study duration
* Any condition(s) or diagnosis, both physical or psychological, or physical exam finding in the opinion of the investigator that would precludes participation

Primary outcomes:
measure: Pain score VAS
timeFrame: Baseline, six weeks, and three months.
Secondary outcomes:
measure: Pain Score NRS
timeFrame: Baseline, six weeks, and three months.
measure: Functional score KOOS
timeFrame: Baseline, six weeks, and three months.
measure: Functional score WOMAC
timeFrame: Baseline, six weeks, and three months.
measure: Pain Medication Adherence
timeFrame: Baseline through three months.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
Study officials:
References: