A Randomized Controlled Trial of Ultrasound-guided Platelet-Rich-Plasma (PRP) Injection Versus Extracorporeal Shock Wave Therapy (ESWT) for Great Trochanter Pain Syndrome (GTPS) With Gluteus Medius or Minimus Tendinopathy

Early Phase 1

Withdrawn

• Conditions: Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy
• Interventions: Biological: Platelet-Rich Plasma Injection; Device: Extracorporeal Shock Wave Therapy

• Registration Number: NCT03774251
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to compare the efficacy of ultrasound-guided platelet-rich plasma (PRP) injection versus extracorporeal shock wave therapy for management of refractory Greater Trochanteric Pain Syndrome (GTPS).

Detailed Description

The purpose of this study is to compare the efficacy of ultrasound-guided platelet-rich plasma (PRP) injection versus extracorporeal shock wave therapy for management of refractory Greater Trochanteric Pain Syndrome (GTPS).

GTPS is a common cause of extra-articular lateral hip pain which occurs in up to 10- 25% of the population, and is a common presenting complaint to primary care and Sports Medicine clinics. Previously, most cases of GTPS were diagnosed as trochanteric bursitis, for which the standard treatment focused on relieving inflammation with non-steroidal anti-inflammatory medications and corticosteroid injections. However, corticosteroid injections typically only provide short term pain relief, likely secondary to the fact that the underlying pathology is likely not from an isolated bursal inflammation. Recent studies suggest that in fact the most common cause of GTPS is gluteus medius or minimus tendinopathy or tear. Platelet rich plasma (PRP) has been used in treating tendinopathies and tendon tears throughout the body to promote healing through the concentrated growth factors released from platelets. Extracorporeal shock wave therapy (ESWT) is another treatment which has been used increasingly in the treatment of tendinopathies. The purpose of this randomized prospective study is to compare the efficacy of PRP injection to ESWT in treating patients with a clinical diagnosis of GTPS.

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-12
• Study Start: 2019-10-01
• Primary Completion: 2020-01-01
• Study Completion: 2021-01-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Individuals with documented diagnosis of greater trochanter pain syndrome, with MRI evidence of gluteus minimus or medius tendinopathy, whose lateral hip pain has been refractory to conservative management with non-steroid anti-inflammatory medications and at least 6 weeks of Physical Therapy.

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Exclusion Criteria

1. Age < 18 or > 65 years
2. Pregnancy
3. Full-thickness tear of the involved gluteal tendons, bursa, and intra-articular structures.
4. Evidence of concomitant injury to the involved lower extremity, including radiculopathy or radiculitis, piriformis syndrome, ischial tuberosity avulsion
5. History of prior steroid injection and Orthobiologic injection or surgery to the involved lower extremity f. Any inflammatory or neoplastic disorder

g. Blood coagulation disorders or use of antiplatelet or anticoagulant drugs h. Severe knee or hip osteoarthritis i. Patients with symptoms of more than 6 months' duration were not considered as patients in the chronic stages of this condition and may require a different therapeutic approach including surgical treatment.

j. Severe Diabetes Mellitus who need insulin injection k. Severe active lumbar radiculopathy with pain, numbness, or weakness in a dermatomal distribution l. Implanted pacemaker

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Greater Trochanter Pain Syndrome - PRP Arm	Platelet-Rich Plasma Injection	Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to undergo platelet rich plasma injection
Greater Trochanter Pain Syndrome - ESWT Arm	Extracorporeal Shock Wave Therapy	Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to extracorporeal shock wave therapy

Primary Outcome Measures

Name	Time	Method
Improvement in Function as measured by the International Hip Outcome Tool (iHot)	4 weeks, 3 months, 6 months, 12 months
Improvement in Function as measured by the Lower extremity functional scale (LEFS)	4 weeks, 3 months, 6 months, 12 months
Improvement in Pain: VAS	4 weeks, 3 months, 6 months, 12 months	Visual Analog Scale (VAS)

Trial Locations

Locations (1)

Stanford Medicine Outpatient Center; 🇺🇸 Redwood City, California, United States