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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUnidade Local de Saúde do Alto Ave, EPE

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Transarterial Musculoskeletal Embolization

    Procedure/Surgery

    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.

  • Platelet-Rich Plasma Injection

    Biological/Vaccine

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Transarterial Musculoskeletal EmbolizationActive comparator 1 intervention
Group B: Platelet-Rich Plasma InjectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 1 month, 3 months, 6 months, and 12 months after treatment

Secondary outcomes

1

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.

Time frame
Baseline, 1 month, 3 months, 6 months, and 12 months after treatment
2

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.

Time frame
Baseline, 1 month, 3 months, 6 months, and 12 months after treatment
3

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.

Time frame
From treatment to 12 months after the procedure

Other outcomes

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