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

NCT03774251 | Withdrawn Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 47910
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Improvement in Pain: VAS

  Visual Analog Scale (VAS)

  4 weeks, 3 months, 6 months, 12 months

• 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

Study Arms (2)

Greater Trochanter Pain Syndrome - PRP Arm

ACTIVE COMPARATOR

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

Greater Trochanter Pain Syndrome - ESWT Arm

ACTIVE COMPARATOR

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

Interventions

Platelet-Rich Plasma Injection BIOLOGICAL

The patient will undergo a single platelet-rich plasma peritendinous injection

Greater Trochanter Pain Syndrome - PRP Arm

Extracorporeal Shock Wave Therapy DEVICE

The patient will undergo a series of three extracorporeal shock wave therapy treatments to the lateral hip

Greater Trochanter Pain Syndrome - ESWT Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Medicine Outpatient Center

Redwood City, California, 94063, United States

Location

Related Publications (9)

• 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.

  PMID: 27610386 BACKGROUND

• 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.

  PMID: 19439758 BACKGROUND

• 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.

  PMID: 28243176 BACKGROUND

• 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.

  PMID: 26990713 BACKGROUND

• 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.

  PMID: 24817008 BACKGROUND

• 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.

  PMID: 27663654 BACKGROUND

• 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.

  PMID: 30016333 BACKGROUND

• 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.

  PMID: 19439756 BACKGROUND

• 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.

  PMID: 29293361 BACKGROUND

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Michael Fredericson, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized prospective study

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 12, 2018
• Study Start: October 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)