Platelet Rich Plasma for Musculoskeletal Conditions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

The primary purpose of this study is to follow patients with various musculoskeletal (MSK) conditions over a one-year follow-up period after receiving a platelet rich plasma (PRP) injection, assessing changes in their pain levels, functional abilities, and overall patient satisfaction.

This will develop a robust registry of patients treated with PRP for a range of MSK conditions. These conditions include, but are not limited to, osteoarthritis (OA) of the knee, hip, glenohumeral joint, elbow, ankle, and sacroiliac joint, as well as rotator cuff tendinopathy, lateral and medial epicondylitis, plantar fasciitis, patellar tendinopathy, Achilles tendinopathy, and proximal hamstring tendinopathy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18+ years old

Musculoskeletal pathology that may benefit from a PRP injection

Failed other conservative treatments

Disqualifiers

No active malignancy

No active infection in the area of injection

No platelet disorder

No active systemic infections

Trial design

Design model

Single group

Treatments tested in this trial

  • Platelet Rich Plasma Injection

    Biological/Vaccine

    Participants who are eligible and provide consent to participate will undergo a Platelet-Rich Plasma (PRP) injection. Their blood will be analyzed using a cell counter, and they will be asked to complete follow-up surveys at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.

  • Platelet Rich Plasma Preparation

    Device

    The patient's blood is collected into syringes. That blood is spun in a centrifuge at high speeds, which separates their blood into layers (red blood cells, white blood cells, and plasma). The plasma portion, which contains the platelets, is transferred to a different syringe for later injection. In some cases, the plasma is spun in the centrifuge again (a "double spin" technique) to further concentrate the platelets in the plasma. The patient's blood is not exposed to air, and it is transferred by tubing between syringes with a Luer Lock connection.

Treatment groups

10,000 Participants
are divided into 1 treatment group
Group A: Platelet Rich Plasma InjectionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Visual analog score (pain)

The VAS is a 0 to 10 scale, with zero being no pain and ten being the worst pain imaginable for their condition

Time frame
6 months

Secondary outcomes

1

Visual Analog Score (pain)

The VAS is a 0 to 10 scale, with zero being no pain and ten being the worst pain imaginable for their condition

Time frame
1, 3, and 12 months
2

Global satisfaction

From a scale of 0 to 100, the subject assesses their total satisfaction with the affected body part. Zero is no satisfaction, while 100 is complete satisfaction.

Time frame
1, 3, 6, 12 months
3

Western Ontario and McMaster Universities Arthritis Index (knee)

The WOMAC is a self-administered questionnaire used to evaluate pain, stiffness, and physical function in people with hip and knee osteoarthritis. Only for patients with knee OA. WOMAC scoring involves summing the scores from its three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Each subscale has a maximum score (Pain: 20, Stiffness: 8, Physical Function: 68), and a total WOMAC score is calculated by adding these three sub-scores together, for a possible total range of 0-96. Higher scores indicate worse symptoms and function.

Time frame
1, 3, 6, 12 months
4

Disorders of the Arm, Shoulder, and Hand (QuickDASH)

The QuickDASH an 11-item patient-reported questionnaire used to measure physical function and symptoms in people with musculoskeletal disorders of the upper limb (arm, shoulder, and hand). To score the QuickDASH, the first sum is the scores from the 11 items, each rated on a 1-5 Likert scale. The sum is then used in the formula: QuickDASH Score = (\[(sum of n responses)/n\]-1)\*25), where (n) is the number of completed items. A minimum of 10 out of 11 items must be completed to calculate a score, and the final score ranges from 0 (no disability) to 100 (most severe disability).

Time frame
1, 3, 6, 12 months

Other outcomes

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