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Greater Trochanteric Pain SyndromeEarly Phase 1NCT02031367

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

A Early Phase 1 study testing Triamcinolone Acetonide and Platelet Rich Plasma in people with Greater Trochanteric Pain Syndrome, run by C.R.Darnall Army Medical Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Greater Trochanteric Pain Syndrome
What is being tested?
Triamcinolone Acetonide and Platelet Rich Plasma
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Mar 2014to Dec 2016
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Aaron D Williams, DO contact

2542867143

aaron.d.williams7.mil@mail.mil

United States1 site

  • Carl R. Darnall Army Medical Center

    Fort Hood, Texas, 76544

    Aaron D Williams, DO

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
Triamcinolone Acetonide, Platelet Rich Plasma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triamcinolone AcetonideDrug

    Corticosteroid arm

  • Platelet Rich PlasmaOther

    Also called PRP

    Platelet Rich Plasma

Study groups in NCT02031367
Study groupRoleWhat they receive
CorticosteroidActive comparatorNot described
Receives: Drug: Triamcinolone Acetonide
Platelet Rich PlasmaExperimentalNot described
Receives: Other: Platelet Rich Plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (1)

  1. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2014 (estimated)
  2. Study startMar 2014
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02031367
Sponsor's protocol ID
GTPS PRP VS Steroid
Status last verified
Jan 2014
First submitted
8 Jan 2014
Last updated
9 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19372352

  • 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.

    PubMed 11592379

  • 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.

    PubMed 20473130

  • 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.

    PubMed 21555750

  • 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.

    PubMed 21240111

  • 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.

    PubMed 21724917

  • 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.

    PubMed 21893483

  • 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.

    PubMed 21814140

  • 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.

    PubMed 20028924

  • 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.

    PubMed 23399297

  • 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.

    PubMed 21543346

  • 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.

    PubMed 12764651

  • 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.

    PubMed 19941093

  • 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.

    PubMed 11733293

  • 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.

    PubMed 12579003

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Triamcinolone Acetonide and Platelet Rich Plasma in people with Greater Trochanteric Pain Syndrome, run by C.R.Darnall Army Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Aaron D Williams, DO (2542867143, aaron.d.williams7.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02031367, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.

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