About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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,
Trial design
Parallel
Treatments tested in this trial
Transarterial Musculoskeletal Embolization
Procedure/SurgeryTransarterial 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.
Platelet-Rich Plasma Injection
Biological/VaccinePlatelet-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.
Treatment groups
Trial outcomes
Primary outcomes
Pain reduction assessed by Visual Analog Scale (VAS)
Change in pain intensity from baseline measured using the Visual Analog Scale (VAS), comparing participants treated with transarterial musculoskeletal embolization (TAME) versus platelet-rich plasma (PRP) injection.
Secondary outcomes
Functional improvement assessed by WOMAC score
Change in functional status from baseline measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), comparing participants treated with transarterial musculoskeletal embolization (TAME) versus platelet-rich plasma (PRP) injection.
Quality of life assessed by EQ-5D-5L questionnaire
Change in health-related quality of life from baseline measured using the EQ-5D-5L questionnaire, comparing participants treated with transarterial musculoskeletal embolization (TAME) versus platelet-rich plasma (PRP) injection.
Incidence of adverse events related to TAME or PRP
Number and severity of procedure-related adverse events associated with transarterial musculoskeletal embolization (TAME) or platelet-rich plasma (PRP) injection, graded according to the CIRSE adverse event classification system.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Unidade Local de Saúde do Alto Ave, EPE
Lead sponsor
Serviço de Ortopedia da ULS Alto Ave
Collaborator
Serviço de Imagiologia da ULS Alto Ave
Collaborator