RCT: PRP versus CS injection in GTPS
Research type
Research Study
Full title
Randomised Controlled Trial: Platelet Rich Plasma Versus Corticosteroid Injection In Greater Trochanteric Pain Syndrome
IRAS ID
117782
Contact name
George McLauchlan
Contact email
Sponsor organisation
Lancashire Teaching Hospital NHS Foundation Trust
Research summary
Title
Randomized Controlled Trial: Platelet Rich Plasma Versus Corticosteroid Injection In Treatment Of Greater Trochanteric Pain Syndrome.Introduction
Greater trochanteric pain syndrome (GTPS) can be severely debilitating and is characterized by lateral hip pain. It is associated with inflammation of the trochanteric bursa and/or tendinosis of Gluteus medius and minimus tendons. Use of corticosteroid injections, is a well-established commonly used non-surgical treatment.
Platelets play an instrumental role in the normal healing response via the local secretion of growth factors and recruitment of reparative cells. Platelet-rich plasma (PRP) is defined as a sample of autologous blood with concentrations of platelets above baseline values.
There is growing evidence supporting the use of PRP injections for the treatment of tendinosis and inflammatory conditions. The use of PRP injections to treat GTPS, although biologically plausible, lacks clinical evidence.Aim
To test the hypothesis that injection of PRP is more effective than corticosteroid injection in treatment of GTPS.Patients & Methods
A prospective interventional study at Lancashire Teaching Hospitals NHS Trust, in which computer generated randomization would be used to recruit 60 patients in each treatment group of a total of 120 patients over a period of 10 -12 months, after obtaining an informed consent.Inclusion criteria:
•Spontaneous pain on the lateral aspect of the hip of at least three month duration.
•Tenderness overlying the greater trochanter, and one of the following three minor diagnostic criteria: increased pain with extremes of rotation, abduction, or adduction; and pain with forced hip abduction.
•Normal hip joint radiograph.
•The patient needs to have intact cognitive function so as to give a valid informed consent. This is also necessary to allow assessment of patient’s response on VAS (Visual analogue scale), satisfaction score (4 point Likert score), disability score and EQ-5D score.
•The patients who might not be able to adequately understand verbal or written information in English will require the use of interpreters.Exclusion Criteria:
•Age < 18 years.
•Previous ipsilateral hip surgery.
•Previous corticosteroid injection in the trochanteric bursa.
•Co-existing coagulopathy, fibromyalgia or previous allergic reaction to PRP or corticosteroid injection.
•Unstable medical or psychiatric condition that might preclude an optimal treatment response.Technique:
•80 mg (2mls) of Depomedrone with 4 mls of 0.5% of Marcaine will be used for the corticosteroid injection.
•The PRP injections will be produced using Exactech’s Accelerate® Concentrating System, which produces 6 mls of PRP from 54 mls of autologous venous blood.
•The injections will be performed under ultrasound guidance by a consultant musculoskeletal radiologist.Blinding:
The radiologist would probably be able to tell which substance is being injected. However the patient will be facing away from the injection and the radiologist would be under instruction not to divulge which substance has been injected. The radiologist would have no further contact with the participant. The participant should therefore remain blinded as would be the person recording the outcome scores.Evaluation:
The patient’s response will be assessed in the clinic follow up at 6 weeks, 6 months and 12 months using VAS (Visual analogue scale), satisfaction score (4 point Likert score), disability score and EQ-5D score.Analysis:
Appropriate statistical methods would be applied to analyse the data.REC name
North West - Preston Research Ethics Committee
REC reference
13/NW/0711
Date of REC Opinion
18 Nov 2013
REC opinion
Further Information Favourable Opinion