Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-18 @ 1:35 AM
Study NCT ID:
NCT02031367
Status:
UNKNOWN
Last Update Posted:
2014-01-09
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater Trochanteric Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014222', 'term': 'Triamcinolone Acetonide'}], 'ancestors': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-08', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Functional outcomes', 'timeFrame': '1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Greater Trochanteric Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '19372352', 'type': 'BACKGROUND', '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.'}, {'pmid': '11592379', 'type': 'BACKGROUND', '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. doi: 10.1002/1529-0131(200109)44:93.0.CO;2-M.'}, {'pmid': '20473130', 'type': 'BACKGROUND', 'citation': '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': '21555750', 'type': 'BACKGROUND', '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.'}, {'pmid': '21240111', 'type': 'BACKGROUND', '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. doi: 10.12968/hmed.2011.72.1.12.'}, {'pmid': '21724917', 'type': 'BACKGROUND', 'citation': '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': '21893483', 'type': 'BACKGROUND', '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.'}, {'pmid': '21814140', 'type': 'BACKGROUND', '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.'}, {'pmid': '20028924', 'type': 'BACKGROUND', 'citation': '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': '23399297', 'type': 'BACKGROUND', '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.'}, {'pmid': '21543346', 'type': 'BACKGROUND', '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.'}, {'pmid': '12764651', 'type': 'BACKGROUND', '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. doi: 10.1007/s00330-002-1740-4. Epub 2002 Nov 23.'}, {'pmid': '19941093', 'type': 'BACKGROUND', '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.'}, {'pmid': '11733293', 'type': 'BACKGROUND', 'citation': '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': '12579003', 'type': 'BACKGROUND', '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. doi: 10.1097/01.blo.0000043047.84315.4b.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females ages 18 and older.\n* Active duty soldiers and military health care beneficiaries.\n* Have lateral hip pain in the region of the greater trochanter for at least 6 weeks and have done physical therapy.\n* Reproducible pain on palpation of the greater trochanteric region.\n* 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\n\nExclusion Criteria:\n\n* Received corticosteroid for the condition in last 6 months.\n* History of surgery in affected hip.\n* Allergy to Lidocaine.\n* Allergy to Corticosteroid.\n* Unavailable for follow up by telephone for 12 months after initial injection.\n* Patients with broken skin or skin infections immediately overlying the area to be injected.\n* Patients with complete tears of the gluteal tendons with retraction of the muscle and or tendon, as determined by ultrasound.\n* 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.\n* Have not attended formal physical therapy'}, 'identificationModule': {'nctId': 'NCT02031367', 'briefTitle': 'Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater Trochanteric Pain Syndrome', 'organization': {'class': 'FED', 'fullName': 'C.R.Darnall Army Medical Center'}, 'officialTitle': 'Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater', 'orgStudyIdInfo': {'id': 'GTPS PRP VS Steroid'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Corticosteroid', 'interventionNames': ['Drug: Triamcinolone Acetonide']}, {'type': 'EXPERIMENTAL', 'label': 'Platelet Rich Plasma', 'interventionNames': ['Other: Platelet Rich Plasma']}], 'interventions': [{'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'description': 'Corticosteroid arm', 'armGroupLabels': ['Corticosteroid']}, {'name': 'Platelet Rich Plasma', 'type': 'OTHER', 'otherNames': ['PRP'], 'description': 'Platelet Rich Plasma', 'armGroupLabels': ['Platelet Rich Plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76544', 'city': 'Fort Hood', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Aaron D Williams, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carl R. Darnall Army Medical Center', 'geoPoint': {'lat': 31.25483, 'lon': -97.70913}}], 'centralContacts': [{'name': 'Aaron D Williams, DO', 'role': 'CONTACT', 'email': 'aaron.d.williams7.mil@mail.mil', 'phone': '2542867143'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C.R.Darnall Army Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Family/Sports Medicine Staff, Family Medicine Residency Center', 'investigatorFullName': 'MAJ Aaron Williams', 'investigatorAffiliation': 'C.R.Darnall Army Medical Center'}}}}