A double blind randomised control trial investigating the efficacy of platelet rich plasma versus placebo for the treatment of greater trochanteric pain syndrome (the HIPPO trial): a protocol for a randomised clinical trial

Abstract

Background: Greater trochanteric pain syndrome (GTPS) is a painful condition characterised by pain around the greater trochanter usually affecting middle-aged women. The majority of patients will improve with conservative management such as physiotherapy and non-steroidal anti-inflammatory drugs (NSAIDs); however, if this fails then more invasive treatments including corticosteroid injections and surgery may be required. Platelet-rich plasma (PRP) is an autologous blood product, which has a higher concentration of growth factors postulated to provide enhanced healing and anti-inflammatory properties. There have been numerous studies on PRP's efficacy in musculoskeletal soft tissue conditions with similar pathology to GTPS, with varying results, most promising being in plantar fasciopathy and patellar tendinopathy. Corticosteroids are the established second-line treatment, but do not always work long term. PRP may be a suitable alternative to corticosteroid in GTPS with longer-term effects; however, there are very limited reports. The Hip Injections PRP Vs Placebo (HIPPO) trial aims to assess the ability of PRP to improve symptoms and function in patients with GTPS.

Methods/design: HIPPO is a single-centre, double-blind randomized placebo-controlled study in patients with a radiologically confirmed diagnosis of gluteus medius or minimus tendinopathy with swelling within the tendon insertion with or without bursitis. We aim to randomise 102 patients with GTPS to either the PRP or placebo (normal saline injection) treatment arm. Participants will receive one ultrasound (US) guided PRP/placebo injection into the trochanteric bursa and surrounding gluteus medius/minimus tendons. The primary outcome measure is the International Hip Outcome Tool-12. Secondary outcome measures will include a visual analogue score for pain, the three-level version of the EuroQol five-dimensional questionnaire and the modified Harris Hip Score. Outcomes will be measured at baseline, 3, 6 and 12 months. Participants will have the option at 6 months to have a repeat blinded injection or cross over to PRP. Analyses of primary and secondary outcomes will be made according to the intention-to-treat principle. The trial reporting will comply with Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Discussion: The HIPPO study has been designed to test the hypothesis that PRP is effective in treating GTPS in patients who have failed conservative management and to assess the duration of effect of PRP.

Trial registration: ClinicalTrials.gov, NCT03479190 . Registered on 27 March 2018.

Keywords: Gluteus medius tendinopathy; Greater trochanteric pain syndrome; Platelet-rich plasma; Trochanteric bursitis.

Conflict of interest statement

Ethics approval and consent to participate

The trial received full ethical approval from Health Research Authority England on 23 October 2017, registration number 198415. The study was also approved by Northumbria Healthcare NHS Foundation Trust. Any modifications to the protocol will be submitted for further ethical approval and approved changes will be documented on the ClinicalTrials.gov registry. The trial will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, 1996; the principles of Good Clinical Practice, and the Department of Health Research Governance Framework for Health and Social Care, 2005. Written informed consent will be obtained from all participants in the trial. Copies of the consent forms will be kept in the trial site files and the patients’ medical notes. Participants will be free to withdraw from the study at any time without giving a reason. All the information collected during this trial will be confidential and held in accordance with NHS Data Protection guidelines and Good Clinical Practice guidelines. Confidentiality will only be breached if patients disclose to us information that may indicate that there is a risk of harm to themselves or others.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Figures

Fig. 1

Standard protocol items: recommendation for interventional trials (SPIRIT) flow diagram. A summary of the planned study interventions and assessments. MRI, magnetic resonance imaging; iHOT-12, International Hip Outcome Tool-12; VAS, visual analogue score; EQ-5D 3 L, Three-level version of the EuroQol five-dimensional questionnaire; MHHS, Modified Harris Hip Score; PRP, platelet-rich plasma

Fig. 2

Study flow chart. GTPS, greater trochanteric pain syndrome; R&D, Research and Development; PROM, patient-reported outcome measure; PRP, platelet-rich plasma; physio, physiotherapy