Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater Trochanteric Pain Syndrome

NCT ID: NCT02031367

Last Updated: 2014-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-12-31

Brief Summary

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The object of this study is to compare the effect of PRP versus Corticosteroid injection on pain in patients with Greater Trochanteric Pain Syndrome up to 12 months after treatment. It is believed that PRP will be as good as corticosteroids for short term pain relief, and will produce longer lasting pain reduction.

Detailed Description

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The purpose of this study is to compare the efficacy of Platelet Rich Plasma (PRP) injections versus Corticosteroid injections in treating patients that have failed noninvasive management for Greater Trochanteric Pain Syndrome (GTPS). We will be comparing in both the short term (0-6 months) and in the long term (6-12 months). It will be a Double-Blinded Randomized Clinical Trial. Patients with GTPS will be randomly assigned to either the Corticosteroid group or PRP group. There will be a total of 50 participants enrolled with 25 in each group. The PRP group will receive 3 mL of autologous plasma injection into the area of tendinopathy utilizing ultrasound guidance. One (1) injection per month will be administered for a total of three (3) injections. The Corticosteroid Group will receive 2.0 mL's injection of lidocaine and 40mg of Triamcinolone into the area of tendinopathy utilizing ultrasound guidance on their first injection. They will then receive 2.0 mL's of 1% lidocaine and 3.0 mL's of 0.9% Sodium Chloride per month for a total of three (3) injections. Both groups will be referred to physical therapy. Participant's pain will be assessed using a Visual Analog Scale (VAS) and the Nonarthritic Hip Score (NHS) for function at the beginning of the treatment and then again at 1, 3, 6, 9, and 12 months after the initial injection.

Conditions

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Greater Trochanteric Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Corticosteroid

Group Type ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type DRUG

Corticosteroid arm

Platelet Rich Plasma

Group Type EXPERIMENTAL

Platelet Rich Plasma

Intervention Type OTHER

Platelet Rich Plasma

Interventions

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Triamcinolone Acetonide

Corticosteroid arm

Intervention Type DRUG

Platelet Rich Plasma

Platelet Rich Plasma

Intervention Type OTHER

Other Intervention Names

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PRP

Eligibility Criteria

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Inclusion Criteria

* Males or females ages 18 and older.
* Active duty soldiers and military health care beneficiaries.
* Have lateral hip pain in the region of the greater trochanter for at least 6 weeks and have done physical therapy.
* Reproducible pain on palpation of the greater trochanteric region.
* Tendinopathy diagnosed with ultrasound. The criteria is as follows: a well-defined hypoechoic area with partial tear or complete tendon rupture that is suggestive of a tendon tear. A hyperechoic intratendinous area with posterior acoustic shadowing suggestive of a calcification, or both

Exclusion Criteria

* Received corticosteroid for the condition in last 6 months.
* History of surgery in affected hip.
* Allergy to Lidocaine.
* Allergy to Corticosteroid.
* Unavailable for follow up by telephone for 12 months after initial injection.
* Patients with broken skin or skin infections immediately overlying the area to be injected.
* Patients with complete tears of the gluteal tendons with retraction of the muscle and or tendon, as determined by ultrasound.
* If they are pregnant or planning on becoming pregnant during the study time. Because of the physiologic changes during pregnancy we cannot predict how Corticosteroids will affect the mother and the infant. Also, this will increase stress to an already immunocompromised state.
* Have not attended formal physical therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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C.R.Darnall Army Medical Center

FED

Sponsor Role lead

Responsible Party

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MAJ Aaron Williams

Family/Sports Medicine Staff, Family Medicine Residency Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Carl R. Darnall Army Medical Center

Fort Hood, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Aaron D Williams, DO

Role: CONTACT

2542867143

References

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Williams BS, Cohen SP. Greater trochanteric pain syndrome: a review of anatomy, diagnosis and treatment. Anesth Analg. 2009 May;108(5):1662-70. doi: 10.1213/ane.0b013e31819d6562.

Reference Type BACKGROUND
PMID: 19372352 (View on PubMed)

Bird PA, Oakley SP, Shnier R, Kirkham BW. Prospective evaluation of magnetic resonance imaging and physical examination findings in patients with greater trochanteric pain syndrome. Arthritis Rheum. 2001 Sep;44(9):2138-45. doi: 10.1002/1529-0131(200109)44:93.0.CO;2-M.

Reference Type BACKGROUND
PMID: 11592379 (View on PubMed)

Strauss EJ, Nho SJ, Kelly BT. Greater trochanteric pain syndrome. Sports Med Arthrosc Rev. 2010 Jun;18(2):113-9. doi: 10.1097/JSA.0b013e3181e0b2ff.

Reference Type BACKGROUND
PMID: 20473130 (View on PubMed)

Brinks A, van Rijn RM, Willemsen SP, Bohnen AM, Verhaar JA, Koes BW, Bierma-Zeinstra SM. Corticosteroid injections for greater trochanteric pain syndrome: a randomized controlled trial in primary care. Ann Fam Med. 2011 May-Jun;9(3):226-34. doi: 10.1370/afm.1232.

Reference Type BACKGROUND
PMID: 21555750 (View on PubMed)

El-Husseiny M, Patel S, Rayan F, Haddad F. Gluteus medius tears: an under-diagnosed pathology. Br J Hosp Med (Lond). 2011 Jan;72(1):12-6. doi: 10.12968/hmed.2011.72.1.12.

Reference Type BACKGROUND
PMID: 21240111 (View on PubMed)

Lachiewicz PF. Abductor tendon tears of the hip: evaluation and management. J Am Acad Orthop Surg. 2011 Jul;19(7):385-91. doi: 10.5435/00124635-201107000-00001.

Reference Type BACKGROUND
PMID: 21724917 (View on PubMed)

Del Buono A, Papalia R, Khanduja V, Denaro V, Maffulli N. Management of the greater trochanteric pain syndrome: a systematic review. Br Med Bull. 2012 Jun;102:115-31. doi: 10.1093/bmb/ldr038. Epub 2011 Sep 4.

Reference Type BACKGROUND
PMID: 21893483 (View on PubMed)

Lustenberger DP, Ng VY, Best TM, Ellis TJ. Efficacy of treatment of trochanteric bursitis: a systematic review. Clin J Sport Med. 2011 Sep;21(5):447-53. doi: 10.1097/JSM.0b013e318221299c.

Reference Type BACKGROUND
PMID: 21814140 (View on PubMed)

Labrosse JM, Cardinal E, Leduc BE, Duranceau J, Remillard J, Bureau NJ, Belblidia A, Brassard P. Effectiveness of ultrasound-guided corticosteroid injection for the treatment of gluteus medius tendinopathy. AJR Am J Roentgenol. 2010 Jan;194(1):202-6. doi: 10.2214/AJR.08.1215.

Reference Type BACKGROUND
PMID: 20028924 (View on PubMed)

Mautner K, Colberg RE, Malanga G, Borg-Stein JP, Harmon KG, Dharamsi AS, Chu S, Homer P. Outcomes after ultrasound-guided platelet-rich plasma injections for chronic tendinopathy: a multicenter, retrospective review. PM R. 2013 Mar;5(3):169-75. doi: 10.1016/j.pmrj.2012.12.010. Epub 2013 Feb 9.

Reference Type BACKGROUND
PMID: 23399297 (View on PubMed)

van Ark M, Zwerver J, van den Akker-Scheek I. Injection treatments for patellar tendinopathy. Br J Sports Med. 2011 Oct;45(13):1068-76. doi: 10.1136/bjsm.2010.078824. Epub 2011 May 3.

Reference Type BACKGROUND
PMID: 21543346 (View on PubMed)

Connell DA, Bass C, Sykes CA, Young D, Edwards E. Sonographic evaluation of gluteus medius and minimus tendinopathy. Eur Radiol. 2003 Jun;13(6):1339-47. doi: 10.1007/s00330-002-1740-4. Epub 2002 Nov 23.

Reference Type BACKGROUND
PMID: 12764651 (View on PubMed)

Fearon AM, Scarvell JM, Cook JL, Smith PN. Does ultrasound correlate with surgical or histologic findings in greater trochanteric pain syndrome? A pilot study. Clin Orthop Relat Res. 2010 Jul;468(7):1838-44. doi: 10.1007/s11999-009-1174-2. Epub 2009 Nov 26.

Reference Type BACKGROUND
PMID: 19941093 (View on PubMed)

Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

Reference Type BACKGROUND
PMID: 11733293 (View on PubMed)

Christensen CP, Althausen PL, Mittleman MA, Lee JA, McCarthy JC. The nonarthritic hip score: reliable and validated. Clin Orthop Relat Res. 2003 Jan;(406):75-83. doi: 10.1097/01.blo.0000043047.84315.4b.

Reference Type BACKGROUND
PMID: 12579003 (View on PubMed)

Other Identifiers

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GTPS PRP VS Steroid

Identifier Type: -

Identifier Source: org_study_id

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