NCT02031367

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2014

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 9, 2014

Status Verified

January 1, 2014

Enrollment Period

2.8 years

First QC Date

January 8, 2014

Last Update Submit

January 8, 2014

Conditions

Greater Trochanteric Pain Syndrome

Outcome Measures

Primary Outcomes (1)

  • Pain

    Will use Visual Analog scale to measure overalll pain at 0, 1, 3, 6, 9, and 12 months of both groups to compare efficacy of both treatments.

    1 year

Secondary Outcomes (1)

  • Functional outcomes

    1 year

Study Arms (2)

Corticosteroid

ACTIVE COMPARATOR
Drug: Triamcinolone Acetonide

Platelet Rich Plasma

EXPERIMENTAL
Other: Platelet Rich Plasma

Interventions

Triamcinolone AcetonideDRUG

Corticosteroid arm

Corticosteroid
Platelet Rich PlasmaOTHER

Platelet Rich Plasma

Also known as: PRP
Platelet Rich Plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carl R. Darnall Army Medical Center

Fort Hood, Texas, 76544, United States

Location

Related Publications (15)

  • 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.

    PMID: 19372352BACKGROUND

  • 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.

    PMID: 11592379BACKGROUND

  • 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.

    PMID: 20473130BACKGROUND

  • 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.

    PMID: 21555750BACKGROUND

  • 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.

    PMID: 21240111BACKGROUND

  • 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.

    PMID: 21724917BACKGROUND

  • 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.

    PMID: 21893483BACKGROUND

  • 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.

    PMID: 21814140BACKGROUND

  • 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.

    PMID: 20028924BACKGROUND

  • 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.

    PMID: 23399297BACKGROUND

  • 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.

    PMID: 21543346BACKGROUND

  • 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.

    PMID: 12764651BACKGROUND

  • 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.

    PMID: 19941093BACKGROUND

  • 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.

    PMID: 11733293BACKGROUND

  • 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.

    PMID: 12579003BACKGROUND

MeSH Terms

Interventions

Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Aaron D Williams, DO

CONTACT

2542867143aaron.d.williams7.mil@mail.mil

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Family/Sports Medicine Staff, Family Medicine Residency Center

Study Record Dates

First Submitted

January 8, 2014

First Posted

January 9, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 9, 2014

Record last verified: 2014-01

Locations

US(1)