NCT07396246

Comparison Between Transarterial Musculoskeletal Embolization and Platelet-Rich Plasma Injection for the Treatment of Greater Trochanteric Pain Syndrome

The HIPE RCT - Comparison Between Transarterial Musculoskeletal Embolization (TAME) and Platelet-Rich Plasma (PRP) Injection for the Treatment of Greater Trochanteric Pain Syndrome - A Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Unidade Local de Saúde do Alto Ave, EPE · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Greater Trochanteric Pain Syndrome (GTPS) is a common cause of lateral hip pain that can significantly affect daily activities and quality of life. Standard treatments include physical therapy, anti-inflammatory medications, and local injections, but many patients continue to experience persistent symptoms. This randomized controlled trial aims to compare two minimally invasive treatment options for GTPS: transarterial musculoskeletal embolization (TAME) and platelet-rich plasma (PRP) injection. Participants will be randomly assigned to receive either TAME or PRP. The main goal of the study is to evaluate which treatment is more effective in reducing pain. Secondary goals include comparing functional improvement, quality of life, and safety between the two treatments. Pain and functional outcomes will be assessed at baseline and during follow-up at 1, 3, 6, and 12 months after treatment. This study seeks to provide evidence on the effectiveness and safety of TAME compared with PRP injection for patients with Greater Trochanteric Pain Syndrome.

Detailed description

This is a prospective, single-center, parallel-group randomized controlled trial designed to compare the efficacy and safety of transarterial musculoskeletal embolization (TAME) versus platelet-rich plasma (PRP) injection in patients with Greater Trochanteric Pain Syndrome (GTPS). Eligible adult patients with clinically and radiologically confirmed GTPS and persistent symptoms despite at least three months of conservative treatment will be enrolled. Participants will be randomized in a 1:1 ratio to receive either TAME or PRP injection. TAME will be performed under local anesthesia by an experienced interventional radiologist, using selective catheterization and embolization of pathological vessels supplying the affected peri-trochanteric structures. A temporary, reabsorbable embolic agent (Nexsphere-F®, CE approved) will be used to achieve a transient embolization effect aimed at reducing pathological neovascularization and inflammation. PRP treatment will consist of a single ultrasound-guided intratendinous injection of autologous platelet-rich plasma into the affected gluteal tendon, performed by an orthopedic hip specialist under sterile conditions. This is a single-blind study. A trained nurse from the radiology department, blinded to treatment allocation, will conduct all follow-up assessments and collect outcome data to minimize assessment bias. The primary outcome measure is pain reduction assessed using the Visual Analog Scale (VAS) at baseline and at 1, 3, 6, and 12 months after treatment. Secondary outcome measures include functional improvement assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), quality of life evaluated with the EQ-5D-5L questionnaire, and the incidence of adverse events graded according to the CIRSE adverse event classification system. A total of 30 participants (15 per group) will be included. Patients who do not achieve at least a 50% reduction in pain at 12 months will be eligible to cross over to the alternative treatment arm. Statistical analysis will include descriptive statistics for baseline characteristics and outcomes. Group comparisons will be performed using independent t-tests or chi-square tests as appropriate. Longitudinal changes will be analyzed using repeated measures analysis of variance or mixed-effects models. Statistical significance will be set at p \< 0.05. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Ethics approval has been obtained from the Unidade Local de Saúde do Alto Ave ethics committee. Written informed consent will be obtained from all participants prior to enrollment.

Conditions

• Trochanteric Syndrome

Interventions

Type	Name	Description
PROCEDURE	Transarterial Musculoskeletal Embolization	Transarterial musculoskeletal embolization (TAME) is performed under local anesthesia by an experienced interventional radiologist. The procedure consists of selective catheterization and embolization of pathological peri-trochanteric vessels supplying the affected hip structures. A temporary, reabsorbable embolic microsphere (Nexsphere-F®, CE approved) is used to achieve transient vessel occlusion, with the objective of reducing pathological neovascularization and inflammation associated with Greater Trochanteric Pain Syndrome.
BIOLOGICAL	Platelet-Rich Plasma Injection	Platelet-rich plasma (PRP) injection consists of a single ultrasound-guided intratendinous administration of autologous PRP into the affected gluteal tendon. PRP is prepared from the participant's own blood using a standardized centrifugation protocol and injected under sterile conditions by an orthopedic hip specialist. The intervention aims to promote tendon healing and reduce pain and functional impairment associated with Greater Trochanteric Pain Syndrome.

Timeline

• Start date: 2026-01-05
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Portugal