Platelet Rich Plasma Versus Placebo for the Treatment of Greater Trochanteric Pain Syndrome (HiPPO Trial)

NCT03479190 | Completed

• 1 other identifier: IRAS 198415
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Greater Trochanteric Pain Syndrome (GTPS), also known as Trochanteric Bursitis, is a painful condition predominantly affecting middle aged women. It is characterised by pain in the lateral hip exacerbated by movement and lying on the affected side. GTPS encompasses different conditions including gluteus medius/minimus tendinopathy and bursal inflammation. The treatment for this condition begins with conservative treatments of analgesia and physiotherapy, which normally results in a resolution of symptoms. If this fails then steroid injections have been shown to be effective. If this is not successful patients are offered surgery. Steroid injections however may only be effective in the short term and sometimes patients require repeat injections. Platelet rich plasma (PRP) is plasma taken from the blood of the patient that has been treated so that it has a higher than usual concentration of platelets in it. It has been postulated to promote healing in damaged or inflamed tissues. Platelets contain a variety of growth factors, which are involved in healing. It has been used in a variety of orthopaedic conditions such as lateral elbow epicondylitis, patellar tendonitis, rotator cuff pathology and planter fasciitis. Studies have shown varying effects of PRP in these conditions with most promise in plantar fasciitis and patellar tendonitis. These conditions are similar to GTPS. A recent review of treatments for GTPS concluded that more research into PRP efficacy in GTPS is required. We hypothesise that PRP is effective in treating GTPS in patients who have not responded to conservative management (analgesia and physiotherapy). This is an area that lacks research and could be valuable to those suffering from GTPS. Further study is required as PRP could be used as instead of steroid injections or if steroid treatments have failed and this could prevent patients from suffering further or needing surgery. The investigators propose a randomised control trial comparing a normal saline injection with a PRP injection in patients with GTPS, diagnosed by MRI scan, who have not responded to conservative treatments. Patients will receive either PRP or normal saline under ultrasound guidance by a consultant rheumatologist. Sample size calculation has shown that the investigators will need to recruit a total of 100 patients who will be randomised into either arm (50 in each arm). The recruitment period will last 2 years with the whole trial aiming to finish in 4 years from the proposed start date. Neither patients or the study team members assessing the outcomes will know which treatment the patient received. Patients will be followed up at 3, 6 and 12 months. The primary outcome measure will be a patient reported outcome measure (PROM) i-HOT12 (international hip outcome tool) which is a valid and reliable scoring system that assesses patient's ability to return to an active lifestyle through obtaining subjective measures of symptoms, as well as determining emotional and social health status. This will be alongside secondary outcome measures Visual Analogue Pain Score, Modified Harris Hip Score and EQ-5D collected. The proposal was discussed with a group of patients who previously had treatment with Platelet Rich Plasma (PRP) injection for hip pain. A discussion was had with regards the setup of a study and they were enthusiastic about this. A patient information sheet was shown to them and modified as per their comments. Their advice was obtained with regards the setup of this study, the randomisation into placebo arm, followup frequency and the outcome measures. In particular, patients suggested that if placebo was not working then a switch over to treatment arm should be discussed sooner than the initially planned one year. This has been taken into account and six month has been agreed. The proposal was also discussed in the NRES committee who are satisfied with the proposal. Ethical approval has been granted and the study is registered with Health Research Authority England.

Conditions

Greater Trochanteric Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• International Hip Outcome Tool (i-HOT12)

  valid and reliable scoring system that assesses patient's ability to return to an active lifestyle through obtaining subjective measures of symptoms, as well as determining emotional and social health status.

  6 months

Secondary Outcomes (3)

• Visual analogue score (VAS)

  6 months

• Modified Harris Hip Score (mHHS)

  6 months

• The 3-level version of EQ-5D (EQ-5D 3L)

  6 months

Study Arms (2)

Platelet rich plasma

ACTIVE COMPARATOR

ultrasound guided injection of Platelet rich plasma

Procedure: ultrasound guided injection of Platelet rich plasma

Normal saline

PLACEBO COMPARATOR

ultrasound guided injection of Normal saline

Procedure: ultrasound guided injection of Normal Saline

Interventions

ultrasound guided injection of Platelet rich plasma PROCEDURE

Platelet rich plasma (PRP) injection into trochanteric area under ultrasound guidance

Platelet rich plasma

ultrasound guided injection of Normal Saline PROCEDURE

ultrasound guided injection of Normal Salineinto trochanteric area under ultrasound guidance

Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Symptoms consistent with GTPS present for at least 6 months
• Radiological diagnosis of GTPS using MRI, or ultrasound scan if MRI contraindicated
• Failed conservative management in any other care setting
• Patient is willing and able to provide written informed consent.

You may not qualify if:

• Lacks capacity to provide consent
• Has hip joint osteoarthritis requiring treatment on a plain radiograph
• Presence of confounding pathologies of the hip MRI
• Any extensive surgery or deformity of the hip on X-ray.
• Presence of systemic disorders -coagulopathy, active infection, immune system disorders, peripheral neuropathy, malignancy, unresolved fractures.
• Had any surgical treatment specifically targeted at GTPS e.g. bursectomy/Ilio-tibial band lengthening
• Pregnancy
• Anti-coagulant therapy eg warfarin, rivaroxaban, apixaban, dabigatran
• Haemaglobin \<10g/dL or platelets \< 150,000/ul
• Unable to safely stop anti-platelet/NSAID medications eg. Recent cardiac stenting
• Has lumbar-sacral spine pathology or a recent history of acute hip trauma
• Has a recent history of acute sciatica
• Is not able to attend or comply with treatment or follow-up scheduling
• Participates in any other clinical trial

Sponsors & Collaborators

• Northumbria Healthcare NHS Foundation Trust: lead

Study Sites (1)

Northumbria Healthcare NHS Trust

Newcastle upon Tyne, TYNE and WEAR, United Kingdom

Location

Related Publications (1)

• Oderuth E, Ali M, Atchia I, Malviya A. 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. Trials. 2018 Sep 21;19(1):517. doi: 10.1186/s13063-018-2907-x.

  PMID: 30241561 DERIVED

Study Officials

• Ajay Malviya

  Northumbria Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Model Details: The trial will be a two arm single centre double blind randomised control trial. The study will include a two-way comparison between PRP and placebo normal saline injections for treating GTPS. Participants will be reviewed at baseline, 3, 6 and 12 with patient reported outcome measures (PROM) completed at each of these reviews.

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 27, 2018
• Study Start: September 3, 2018
• Primary Completion: February 28, 2022
• Study Completion: April 3, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

GB (1)