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

Greater Trochanteric Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02031367
• Other study ID #: GTPS PRP VS Steroid
• Status: Not yet recruiting
• Phase: Phase 0
• First received: January 8, 2014
• Last updated: January 8, 2014
• Start date: March 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2014
• Source: C.R.Darnall Army Medical Center
• Contact: Aaron D Williams, DO
• Phone: 2542867143
• Email: aaron.d.williams7.mil[@]mail.mil
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Greater Trochanteric Pain Syndrome

Intervention

Drug:
• Triamcinolone Acetonide
Corticosteroid arm

Other:
• Platelet Rich Plasma
Platelet Rich Plasma

Locations

Country	Name	City	State
United States	Carl R. Darnall Army Medical Center	Ft. Hood	Texas

Sponsors (1)

Lead Sponsor	Collaborator
C.R.Darnall Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. Erratum in: Ann Fam Med. 2011 Jul-Aug;9(3):371. — View Citation

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. — View Citation

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. Epub 2002 Nov 23. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Labrosse JM, Cardinal E, Leduc BE, Duranceau J, Rémillard 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. — View Citation

Lachiewicz PF. Abductor tendon tears of the hip: evaluation and management. J Am Acad Orthop Surg. 2011 Jul;19(7):385-91. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Functional outcomes	Will use Nonarthritic Hip score at 0, 1, 3, 6, 9, and 12 months to evaluate overall function of the patients between the two groups.	1 year	No