Efficacy of Platelet-Rich Plasma Versus Placebo for the Treatment of Greater Trochanteric Pain Syndrome: A Double-Blinded Randomized Controlled Trial.

IF 4.4 1区医学 Q1 ORTHOPEDICS Journal of Bone and Joint Surgery, American Volume Pub Date : 2025-01-13 DOI:10.2106/JBJS.24.00763

Ismael Atchia, Mohammed Ali, Eshan Oderuth, Richard Holleyman, Ajay Malviya

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Abstract

Background: Greater trochanteric pain syndrome (GTPS) is a painful condition that can impair a patient's quality of life. If nonoperative measures fail, progressively more invasive treatment options may be required. This clinical trial aimed to evaluate the effectiveness of ultrasound-guided leukocyte-rich platelet-rich plasma (LR-PRP) injections in the treatment of refractory GTPS caused by bursitis and/or gluteal tendinopathy.

Methods: An ethically approved, adequately powered, double-blinded randomized controlled trial (RCT) was conducted to evaluate the clinical outcomes in randomized LR-PRP and placebo groups using the International Hip Outcome Tool-12 (iHOT-12), a visual analogue scale (VAS) for pain, the modified Harris hip score (mHHS), the EuroQol 5-Dimensions (EQ-5D) questionnaire, and the presence or absence of complications. All injections were performed under ultrasound guidance into the trochanteric bursa and gluteus medius tendon.

Results: The final analysis included 79 patients (39 in the LR-PRP and 40 in the placebo group; 73 female and 6 male; all Caucasian). Both the LR-PRP and the placebo group generally had improvement from baseline that was maintained to 12 months. The only deterioration in scores compared to baseline was seen in the LR-PRP group for the iHOT-12 at 12 months, the EQ-5D index at 3 and 6 months, and the EQ-5D VAS at all follow-up time points. However, there was no significant difference between the 2 groups at any follow-up point (p > 0.05). A multivariable linear regression model, with adjustment for age, sex, body mass index, and preoperative baseline score, did not reveal any significant associations between iHOT-12 and EQ-5D score gains at 12 months and treatment.

Conclusions: This randomized trial found no significant difference in outcomes between LR-PRP and placebo for the treatment of greater trochanteric pain up to 6 months following the intervention. As a result, we do not support the routine use of PRP for the treatment of this condition.

Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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富血小板血浆与安慰剂治疗大转子疼痛综合征的疗效：一项双盲随机对照试验

背景：大转子疼痛综合征（GTPS）是一种会影响患者生活质量的疼痛症状。如果非手术治疗失败，可能需要逐步增加侵入性治疗。本临床试验旨在评估超声引导下富白细胞富血小板血浆（LR-PRP）注射治疗由滑囊炎和/或臀腱病引起的难治性GTPS的有效性。方法：采用国际髋关节结局工具-12 （iHOT-12）、疼痛视觉模拟量表（VAS）、改良Harris髋关节评分（mHHS）、EuroQol 5-Dimensions （EQ-5D）问卷以及是否存在并发症，进行一项经伦理批准、充分支持的双盲随机对照试验（RCT），评估随机LR-PRP组和安慰剂组的临床结果。所有注射均在超声引导下进行，注射部位为粗隆囊和臀中肌腱。结果：最终分析纳入79例患者(LR-PRP组39例，安慰剂组40例；女性73人，男性6人；所有的白人)。LR-PRP组和安慰剂组一般都有改善，从基线维持到12个月。与基线相比，LR-PRP组在12个月时的iHOT-12、3个月和6个月时的EQ-5D指数以及所有随访时间点的EQ-5D VAS评分均出现了唯一的恶化。然而，两组在任何随访点之间均无显著差异（p < 0.05）。对年龄、性别、体重指数和术前基线评分进行调整的多变量线性回归模型显示，iHOT-12和EQ-5D评分在12个月和治疗时的增加之间没有任何显著关联。结论：这项随机试验发现，干预后6个月，LR-PRP和安慰剂治疗大转子疼痛的结果无显著差异。因此，我们不支持常规使用PRP治疗这种情况。证据水平：治疗性i级。参见《作者说明》获得证据水平的完整描述。

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来源期刊

Journal of Bone and Joint Surgery, American Volume 医学-外科

CiteScore

8.90

自引率

7.50%

发文量

660

审稿时长

1 months

期刊介绍： The Journal of Bone & Joint Surgery (JBJS) has been the most valued source of information for orthopaedic surgeons and researchers for over 125 years and is the gold standard in peer-reviewed scientific information in the field. A core journal and essential reading for general as well as specialist orthopaedic surgeons worldwide, The Journal publishes evidence-based research to enhance the quality of care for orthopaedic patients. Standards of excellence and high quality are maintained in everything we do, from the science of the content published to the customer service we provide. JBJS is an independent, non-profit journal.