Overview
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.
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.
Eligibility
Inclusion Criteria:
- Diagnosis of GTPS confirmed by clinical and imaging assessments
- Persistent symptoms despite at least 3 months of conservative treatment (e.g., physical therapy, NSAIDs)
- Willingness to participate and provide informed consent
- Availability for follow-up assessments at 1, 3, 6, and 12 months post-treatment
Exclusion Criteria:
- Prior hip surgery or other interventions (e.g., joint replacement, prior PRP injections or embolization)
- Severe osteoarthritis (Tonnis III)
- Active lumbar radiculopathy with pain, numbness, or weakness in a dermatomal distribution
- Contraindications for PRP injections (e.g., active infection, coagulopathy, antiplatelet or anticoagulation therapy,
- Pregnancy or breastfeeding
- Severe comorbidities that would interfere with participation
- Active cancer or other malignancies
