Clinical trial NCT02031367: Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater Trochanteric Pain Syndrome
Official title: Efficacy of Platelet Rich Plasma vs. Corticosteroid Injections for Treating Greater
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Greater Trochanteric Pain Syndrome
Lead sponsor: C.R.Darnall Army Medical Center
Sponsor class: FED
First posted: 2014-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: 1 year
Secondary outcomes:
measure: Functional outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Ft. Hood
country: United States
facility: Carl R. Darnall Army Medical Center
state: Texas
Study officials:
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