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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

Primary Purpose

Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Platelet-Rich Plasma Injection
Extracorporeal Shock Wave Therapy
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Stanford Medicine Outpatient Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Greater Trochanter Pain Syndrome - PRP Arm

Greater Trochanter Pain Syndrome - ESWT Arm

Arm Description

Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to undergo platelet rich plasma injection

Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to extracorporeal shock wave therapy

Outcomes

Primary Outcome Measures

Improvement in Pain: VAS
Visual Analog Scale (VAS)
Improvement in Function as measured by the International Hip Outcome Tool (iHot)
Improvement in Function as measured by the Lower extremity functional scale (LEFS)

Secondary Outcome Measures

Full Information

First Posted
December 4, 2018
Last Updated
September 15, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03774251
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not secured
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized prospective study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Greater Trochanter Pain Syndrome - PRP Arm
Arm Type
Active Comparator
Arm Description
Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to undergo platelet rich plasma injection
Arm Title
Greater Trochanter Pain Syndrome - ESWT Arm
Arm Type
Active Comparator
Arm Description
Individuals with Greater Trochanter Pain Syndrome with MRI evidence of gluteus medius or gluteus minimus tendinopathy, assigned to extracorporeal shock wave therapy
Intervention Type
Biological
Intervention Name(s)
Platelet-Rich Plasma Injection
Intervention Description
The patient will undergo a single platelet-rich plasma peritendinous injection
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Wave Therapy
Intervention Description
The patient will undergo a series of three extracorporeal shock wave therapy treatments to the lateral hip
Primary Outcome Measure Information:
Title
Improvement in Pain: VAS
Description
Visual Analog Scale (VAS)
Time Frame
4 weeks, 3 months, 6 months, 12 months
Title
Improvement in Function as measured by the International Hip Outcome Tool (iHot)
Time Frame
4 weeks, 3 months, 6 months, 12 months
Title
Improvement in Function as measured by the Lower extremity functional scale (LEFS)
Time Frame
4 weeks, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Age < 18 or > 65 years Pregnancy Full-thickness tear of the involved gluteal tendons, bursa, and intra-articular structures. Evidence of concomitant injury to the involved lower extremity, including radiculopathy or radiculitis, piriformis syndrome, ischial tuberosity avulsion 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Fredericson, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Medicine Outpatient Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27610386
Citation
Zhou Y, Wang JH. PRP Treatment Efficacy for Tendinopathy: A Review of Basic Science Studies. Biomed Res Int. 2016;2016:9103792. doi: 10.1155/2016/9103792. Epub 2016 Aug 16.
Results Reference
background
PubMed Identifier
19439758
Citation
Rompe JD, Segal NA, Cacchio A, Furia JP, Morral A, Maffulli N. Home training, local corticosteroid injection, or radial shock wave therapy for greater trochanter pain syndrome. Am J Sports Med. 2009 Oct;37(10):1981-90. doi: 10.1177/0363546509334374. Epub 2009 May 13.
Results Reference
background
PubMed Identifier
28243176
Citation
Ribeiro AG, Ricioli W Junior, Silva AR, Polesello GC, Guimaraes RP. PRP IN THE TREATMENT OF TROCHANTERIC SYNDROME: A PILOT STUDY. Acta Ortop Bras. 2016 Jul-Aug;24(4):208-212. doi: 10.1590/1413-785220162404159837.
Results Reference
background
PubMed Identifier
26990713
Citation
Redmond JM, Chen AW, Domb BG. Greater Trochanteric Pain Syndrome. J Am Acad Orthop Surg. 2016 Apr;24(4):231-40. doi: 10.5435/JAAOS-D-14-00406.
Results Reference
background
PubMed Identifier
24817008
Citation
Mani-Babu S, Morrissey D, Waugh C, Screen H, Barton C. The effectiveness of extracorporeal shock wave therapy in lower limb tendinopathy: a systematic review. Am J Sports Med. 2015 Mar;43(3):752-61. doi: 10.1177/0363546514531911. Epub 2014 May 9.
Results Reference
background
PubMed Identifier
27663654
Citation
Jacobson JA, Yablon CM, Henning PT, Kazmers IS, Urquhart A, Hallstrom B, Bedi A, Parameswaran A. Greater Trochanteric Pain Syndrome: Percutaneous Tendon Fenestration Versus Platelet-Rich Plasma Injection for Treatment of Gluteal Tendinosis. J Ultrasound Med. 2016 Nov;35(11):2413-2420. doi: 10.7863/ultra.15.11046. Epub 2016 Sep 23.
Results Reference
background
PubMed Identifier
30016333
Citation
Seo KH, Lee JY, Yoon K, Do JG, Park HJ, Lee SY, Park YS, Lee YT. Long-term outcome of low-energy extracorporeal shockwave therapy on gluteal tendinopathy documented by magnetic resonance imaging. PLoS One. 2018 Jul 17;13(7):e0197460. doi: 10.1371/journal.pone.0197460. eCollection 2018.
Results Reference
background
PubMed Identifier
19439756
Citation
Furia JP, Rompe JD, Maffulli N. Low-energy extracorporeal shock wave therapy as a treatment for greater trochanteric pain syndrome. Am J Sports Med. 2009 Sep;37(9):1806-13. doi: 10.1177/0363546509333014. Epub 2009 May 13.
Results Reference
background
PubMed Identifier
29293361
Citation
Fitzpatrick J, Bulsara MK, O'Donnell J, McCrory PR, Zheng MH. The Effectiveness of Platelet-Rich Plasma Injections in Gluteal Tendinopathy: A Randomized, Double-Blind Controlled Trial Comparing a Single Platelet-Rich Plasma Injection With a Single Corticosteroid Injection. Am J Sports Med. 2018 Mar;46(4):933-939. doi: 10.1177/0363546517745525. Epub 2018 Jan 2.
Results Reference
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Learn more about this trial

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

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