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NCT03774251 Clinical 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

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

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03774251
Other study ID # 47910
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date October 1, 2019
Est. completion date January 1, 2021

Study information
Verified date September 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 1, 2021
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Platelet-Rich Plasma Injection
The patient will undergo a single platelet-rich plasma peritendinous injection
Device:
• Extracorporeal Shock Wave Therapy
The patient will undergo a series of three extracorporeal shock wave therapy treatments to the lateral hip

Locations
Country Name City State
United States Stanford Medicine Outpatient Center Redwood City California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. Epub 2016 Sep 23. — View 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. Review. — View 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. Review. — View Citation

Ribeiro AG, Ricioli W Junior, Silva AR, Polesello GC, Guimarães 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. — View 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. — View 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. — View 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. Review. — View Citation

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