富血小板血浆对足底筋膜炎疼痛的积极影响：一项双盲、多中心随机对照试验。

Positive Effect of Platelet-Rich Plasma on Pain in Plantar Fasciitis: A Double-Blind Multicenter Randomized Controlled Trial.

机构信息

Department of Orthopaedics, Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands.

Department of Methodology and Statistics, Tilburg University, Tilburg, the Netherlands.

出版信息

Am J Sports Med. 2019 Nov;47(13):3238-3246. doi: 10.1177/0363546519877181. Epub 2019 Oct 11.

DOI:10.1177/0363546519877181

PMID:31603721

Abstract

BACKGROUND

When nonoperative treatment for chronic plantar fasciitis fails, often a corticosteroid injection is given. Corticosteroid injection gives temporary pain reduction but no healing. Platelet-rich plasma (PRP) has proven to be a safe therapeutic option in the treatment of tendon, muscle, bone, and cartilage injuries.

PURPOSE

To determine the effectiveness of PRP as compared with corticosteroid injections for chronic plantar fasciitis.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

Patients with chronic plantar fasciitis were allocated to have steroid injection or PRP. The primary outcome measure was the Foot Function Index (FFI) Pain score. Secondary outcome measures were function, as scored by the FFI Activity, FFI Disability, and American Orthopaedic Foot & Ankle Society, and quality of life, as scored with the short version of the World Health Organization Quality of Life (WHOQOL-BREF). All outcomes were measured at baseline and at 4, 12, and 26 weeks and 1 year after the procedure.

RESULTS

Of the 115 patients, 63 were allocated to the PRP group, of which 46 (73%) completed the study, and 52 were allocated to the control group (corticosteroid injection), of which 36 (69%) completed the study. In the control group, FFI Pain scores decreased quickly and then remained stable during follow-up. In the PRP group, FFI Pain reduction was more modest but reached a lower point after 12 months than the control group. After adjusting for baseline differences, the PRP group showed significantly lower pain scores at the 1-year follow-up than the control group (mean difference, 14.4; 95% CI, 3.2-25.6). The number of patients with at least 25% improvement (FFI Pain score) between baseline and 12-month follow-up differed significantly between the groups. Of the 46 patients in the PRP group, 39 (84.4%) improved at least 25%, while only 20 (55.6%) of the 36 in the control group showed such an improvement ( = .003). The PRP group showed significantly lower FFI Disability scores than the control group (mean difference, 12.0; 95% CI, 2.3-21.6).

CONCLUSION

Treatment of patients with chronic plantar fasciitis with PRP seems to reduce pain and increase function more as compared with the effect of corticosteroid injection.

REGISTRATION

NCT00758641 (ClinicalTrials.gov identifier).

摘要

背景

当慢性足底筋膜炎的非手术治疗失败时，通常会给予皮质类固醇注射。皮质类固醇注射可暂时减轻疼痛，但不能治愈。富含血小板的血浆 (PRP) 已被证明是治疗肌腱、肌肉、骨骼和软骨损伤的安全治疗选择。

目的

确定 PRP 与皮质类固醇注射治疗慢性足底筋膜炎的效果比较。

研究设计

随机对照试验；证据水平，1 级。

方法

将患有慢性足底筋膜炎的患者分配接受皮质类固醇注射或 PRP。主要结局测量指标是足功能指数 (FFI) 疼痛评分。次要结局测量指标包括功能，由 FFI 活动、FFI 残疾和美国矫形足踝协会评分，以及生活质量，由世界卫生组织生活质量量表 (WHOQOL-BREF) 短版评分。所有结局均在基线以及治疗后 4、12 和 26 周和 1 年进行测量。

结果

在 115 名患者中，63 名被分配到 PRP 组，其中 46 名（73%）完成了研究，52 名被分配到对照组（皮质类固醇注射），其中 36 名（69%）完成了研究。在对照组中，FFI 疼痛评分迅速下降，随后在随访过程中保持稳定。在 PRP 组中，FFI 疼痛缓解程度较低，但在 12 个月后低于对照组。在调整基线差异后，PRP 组在 1 年随访时的疼痛评分明显低于对照组（平均差异，14.4；95%CI，3.2-25.6）。两组之间至少有 25%改善（FFI 疼痛评分）的患者数量存在显著差异。在 PRP 组的 46 名患者中，39 名（84.4%）至少改善了 25%，而对照组的 36 名患者中只有 20 名（55.6%）显示出这种改善（ =.003）。PRP 组的 FFI 残疾评分明显低于对照组（平均差异，12.0；95%CI，2.3-21.6）。