Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy

Study Overview
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Brief Summary
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Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by side lying, stair climbing, and walking. Treatment is currently limited to lifestyle modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical repair. Platelet rich plasma (PRP) injections contain important growth factors that are essential in the healing and tissue formation processes. However, the extent to which PRP is more efficacious than whole blood in tendinopathy remains unclear. In this double-blind randomized trial, patients will be allocated to receive either a PRP or whole-blood injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months, and 1 year.

Official Title
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Ultrasound-Guided Platelet Rich Plasma Versus Whole Blood Injection for the Treatment of Gluteus Medius Tendinopathy: A Double-Blind Randomized Controlled Study

Conditions
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Hip Pain, Tendinopathy

Intervention / Treatment
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* Biological: PRP
* Biological: Whole Blood
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe lateral hip pain for greater than 3 months Symptoms are refractory to conservative treatment, including at least 8 weeks of traditional physical therapy for this condition Moderate to severe gluteus medius tendinosis with or without partial tear <1 cm Normal neurologic exam except for hip abductor weakness on the affected side Exclusion Criteria: Severe (Tonnis grade >1) hip osteoarthritis with active synovitis or bone edema Active lumbar radiculopathy with pain, numbness or weakness in a dermatomal distribution No evidence of fatty atrophy, denervation, or complete tears of gluteus medius seen on MRI Any condition that requires anti-platelet or anti-coagulation therapy, including aspirin therapy for cardiac conditions Non-English speaking

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP<br> | Biological: PRP<br> <br> Device: Ultrasound<br> <br> |
| Active Comparator: Whole Blood<br> | Biological: Whole Blood<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Pain | The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain. | Up to 1 year post-injection | 
| Improvement in Function | The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function. | Up to 1 year post-injection | 
| Patient Satisfaction | The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from very dissatisfied to extremely satisfied. | Up to 1 year post-injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Movement During the Forward Step-down Test | The quality of movement will be assessed on a scale of 0-4+, where 4+=good, 2-3=moderate, and 0-1=poor. | Up to 1 year post-injection | 
| Pain During Side-lying Hip Abduction | Pain will be assessed using the 10-cm Visual Analog Scale, which will range from no pain to worst possible pain. | Up to 1 year post-injection | 
| Pain During Forward Step-down Test | Pain will be assessed using the 10-cm Visual Analog Scale, which will range from no pain to worst possible pain. | Up to 1 year post-injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gluteus Medius Tendinosis