What side effects are associated with this type of intervention?

Common treatments for shoulder osteoarthritis include corticosteroid injections and platelet-rich plasma (PRP) injections. Corticosteroid injections can provide short-term pain relief but may lead to side effects such as tendon weakening or rupture, local infection, and potential systemic effects like elevated blood sugar levels. PRP injections, including leukocyte-poor PRP (LP-PRP), are generally considered safe with minor and transient side effects such as pain, tenderness, swelling, and bruising at the injection site. However, there is a general risk of local infection associated with any intra-articular injection.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments of shoulder osteoarthritis similar to leukocyte-poor platelet-rich plasma (LP-PRP) injections. However, it does highlight that PRP, which contains growth factors that facilitate local tissue regeneration, is a promising non-operative treatment for conditions like tendinopathy and osteoarthritis. PRP is noted for its potential to enhance soft tissue healing, making it a valuable option for patients with refractory shoulder osteoarthritis, although high-level evidence-based studies are still needed to establish its efficacy and standardize its use.

What other types of research exist?

Promising alternatives to LP-PRP injections for shoulder osteoarthritis include autologous tenocyte injections and autologous blood injections. These therapies have shown potential in treating musculoskeletal conditions by promoting tissue regeneration and healing. Additionally, active physical training remains a viable non-operative treatment option.

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Corticosteroid

PRP vs Corticosteroid Injections for Shoulder Osteoarthritis (PRP Trial)

Phase 3

Waitlist Available

Research Sponsored by Walter Reed National Military Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female, aged 18 to 70 years (inclusive)

Glenohumeral joint osteoarthritis that has been refractory to standard care treatments

Must not have

Patients who have undergone arthroscopic surgery on the study shoulder within the past year

Patients who have had an adverse reaction to a previous corticosteroid or PRP injection either documented in the medical record or shared by the patient during screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial investigates LP-PRP injections for young active duty and civilian patients with shoulder osteoarthritis. The treatment uses concentrated platelets from the patient's own blood to promote healing and reduce inflammation, aiming to improve pain and function without surgery. This method has shown potential in treating various inflammatory and degenerative conditions by modulating the inflammatory environment and promoting tissue repair.

Who is the study for?

This trial is for men and women aged 18-70 with shoulder pain from mild to moderate osteoarthritis that hasn't improved with standard treatments. They must not have had recent injections or surgery in the affected shoulder, be pregnant, or have conditions like diabetes, fibromyalgia, chronic fatigue syndrome, or a history of bad reactions to PRP or corticosteroids.

What is being tested?

The study compares three non-surgical treatments for shoulder osteoarthritis: Platelet Rich Plasma (PRP) injection, Corticosteroid injection, and delayed PRP after Corticosteroid failure. It aims to find out which treatment might best help young active people avoid surgery by improving tissue healing.

What are the potential side effects?

Possible side effects include pain at the injection site, infection risk increase due to the procedure itself. For corticosteroids specifically there's potential tendon weakening near the joint. PRP generally has fewer side effects as it uses patient's own blood components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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My shoulder arthritis hasn't improved with standard treatments.

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I have shoulder pain from mild to moderate arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had shoulder surgery within the last year.

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I had a bad reaction to a previous steroid or PRP shot.

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I have been diagnosed with fibromyalgia or chronic fatigue syndrome.

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I am currently pregnant or nursing.

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I have had joint replacement surgery on my shoulder.

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I have diabetes.

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I am currently taking prescription pain medication.

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I have an inflammatory joint condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-injection (baseline) and then post-injection at 3 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in range of motion (ROM) from before injection to after injection

Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before injection to after injection

Change in the Single Assessment Numeric Evaluation (SANE) from before injection to after injection

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Platelet Rich Plasma Injection GroupExperimental Treatment1 Intervention

Minimum 2cc Leukocyte Poor Platelet Rich Plasma

Group II: Delayed Platelet Rich Plasma Injection Group upon Corticosteroid Injection FailureExperimental Treatment1 Intervention

If a participant does not have any benefit from the corticosteroid injection by the six-week follow-up time point, then that participant will be eligible for a platelet rich plasma injection.

Group III: Corticosteroid Injection GroupActive Control1 Intervention

5cc Normal Saline + 2cc 10 mg/ml Triamcinolone Acetonide (Kenalog)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platelet Rich Plasma Injection

2021

Completed Early Phase 1

~50

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for shoulder osteoarthritis include corticosteroid injections, nonsteroidal anti-inflammatory drugs (NSAIDs), and platelet-rich plasma (PRP) injections. Corticosteroid injections provide short-term pain relief by reducing inflammation but do not address the underlying pathology and may risk tendon damage. NSAIDs alleviate pain and inflammation but are limited by potential side effects with long-term use. LP-PRP injections, derived from the patient's own blood, are promising because they contain growth factors that enhance soft tissue healing and facilitate local tissue regeneration. This is particularly relevant for shoulder OA patients as it offers a potential treatment that not only alleviates symptoms but also promotes tissue repair, potentially improving joint function and delaying disease progression.