Department of Orthopaedics and Rheumatology, University Hospital Giessen and Marburg, Marburg, Germany.
Clin J Pain. 2012 Jul;28(6):527-33. doi: 10.1097/AJP.0b013e31823ae65a.
Botulinum toxin A (BoNT-A) is used as an alternative treatment for chronic orthopedic conditions. This study was conducted to investigate the efficacy and safety of BoNT-A on pain and functional outcome in patients with chronic plantar fasciitis.
In this short-term, randomized, multicenter, double-blind, placebo-controlled study, patients (N=40) were randomized to receive 200 units of BoNT-A (Dysport) or saline placebo. The injection was administered in a fan-shaped manner directly at the calcaneal origin of the plantar fascia. The primary outcome measure was the proportion of responders at week 6 [≥50% decrease from baseline in pain score (visual analog scale) while moving during the previous 48 h). Global assessments were performed by the patient and physician at each visit up to week 18.
More patients in the BoNT-A group achieved a response at week 6 (25% vs. 5% for placebo; P=0.18). Differences between treatments were in favor of BoNT-A on secondary measures of pain, but did not reach statistical significance. In the BoNT-A group, 52.7% (vs. 40% for placebo) assessed their condition as slightly/significantly improved at week 6. At study endpoint (week 18), 63.1% of the BoNT-A group perceived an improvement versus 55% of the placebo group. There was no difference in global assessment between physician and patient. No adverse events related to treatment were noted.
There is a need for larger, prospective, long-term, placebo-controlled studies to fully establish the role of BoNT-A for the treatment of plantar fasciitis.
肉毒杆菌毒素 A(BoNT-A)可作为治疗慢性骨科疾病的替代方法。本研究旨在探讨 BoNT-A 治疗慢性足底筋膜炎患者疼痛和功能结局的疗效和安全性。
在这项短期、随机、多中心、双盲、安慰剂对照研究中,将 40 例患者随机分为接受 200 单位 BoNT-A(Dysport)或生理盐水安慰剂组。注射以扇形方式直接在足底筋膜跟骨起点进行。主要终点是第 6 周时的应答者比例[与基线相比疼痛评分(视觉模拟评分)在过去 48 小时内移动时下降≥50%]。在第 18 周之前的每次就诊时,患者和医生都进行了总体评估。
BoNT-A 组在第 6 周时有更多患者达到应答(25%对安慰剂组的 5%;P=0.18)。在次要疼痛测量方面,治疗之间的差异有利于 BoNT-A,但未达到统计学意义。在 BoNT-A 组中,52.7%(安慰剂组为 40%)在第 6 周时评估自己的病情略有/明显改善。在研究终点(第 18 周)时,BoNT-A 组有 63.1%的患者认为病情有所改善,而安慰剂组为 55%。医生和患者的总体评估无差异。未观察到与治疗相关的不良事件。
需要进行更大、前瞻性、长期、安慰剂对照研究,以充分确立 BoNT-A 在治疗足底筋膜炎中的作用。