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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain reduction assessed by Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Transarterial Musculoskeletal Embolization
Participants assigned to this arm will undergo transarterial musculoskeletal embolization (TAME) under local anesthesia. The procedure will be performed by an experienced interventional radiologist using selective catheterization of pathological peri-trochanteric vessels supplying the affected hip structures. Embolization will be carried out using a temporary, reabsorbable embolic microsphere (Nexsphere-F®, CE approved) to achieve transient vessel occlusion. The aim of the procedure is to reduce pathological neovascularization and inflammation associated with Greater Trochanteric Pain Syndrome.
干预措施: Transarterial Musculoskeletal Embolization (Procedure)
Platelet-Rich Plasma Injection
Participants assigned to this arm will receive a single ultrasound-guided intratendinous injection of autologous platelet-rich plasma (PRP) into the affected gluteal tendon. The procedure will be performed by an orthopedic hip specialist under sterile conditions. PRP will be prepared from the participant's own blood using a standardized centrifugation protocol. The objective of this intervention is to promote tendon healing and reduce pain and functional impairment associated with Greater Trochanteric Pain Syndrome.
干预措施: Platelet-Rich Plasma Injection (Biological)
结局指标
主要结局
Pain reduction assessed by Visual Analog Scale (VAS)
时间窗: Baseline, 1 month, 3 months, 6 months, and 12 months after treatment
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.
次要结局
- Functional improvement assessed by WOMAC score(Baseline, 1 month, 3 months, 6 months, and 12 months after treatment)
- Quality of life assessed by EQ-5D-5L questionnaire(Baseline, 1 month, 3 months, 6 months, and 12 months after treatment)
- Incidence of adverse events related to TAME or PRP(From treatment to 12 months after the procedure)
研究者
Pedro Lopes
Interventional Radiologist
Unidade Local de Saúde do Alto Ave, EPE