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

September 15, 2021 updated by: Michael Fredericson, MD, Stanford University
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94063
        • Stanford Medicine Outpatient Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Greater Trochanter Pain Syndrome - PRP Arm
Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to undergo platelet rich plasma injection
Biological: Platelet-Rich Plasma Injection
The patient will undergo a single platelet-rich plasma peritendinous injection
Active Comparator: Greater Trochanter Pain Syndrome - ESWT Arm
Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to extracorporeal shock wave therapy
Device: Extracorporeal Shock Wave Therapy
The patient will undergo a series of three extracorporeal shock wave therapy treatments to the lateral hip

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Michael Fredericson, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (Actual)

December 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 47910

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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