Ahmad Jamal, Ahmad Stacy H, Jones Kennis
1 Orthopaedic Foot and Ankle Surgery, Rothman Institute Orthopaedics, Philadelphia, PA, USA.
2 Department of Anatomy, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA.
Foot Ankle Int. 2017 Jan;38(1):1-7. doi: 10.1177/1071100716666364. Epub 2016 Oct 1.
This study examined the effect of botulinum toxin upon plantar fasciitis through a randomized, controlled, and blinded trial.
Between 2012 and 2015, 50 patients presented with plantar fasciitis. Twenty-five patients each randomly received an IncobotulinumtoxinA (IBTA) or saline injection of their affected foot. Pre- and postinjection function and pain were graded with the Foot and Ankle Ability Measures (FAAM) and visual analog scale (VAS), respectively. All 50 study patients who randomly received either placebo or IBTA presented at 6 and 12 months after injection.
At 6 months, the mean FAAM increased from 35.9 to 40.9 of 100, and the mean pain score decreased from 8.4 to 7.9 of 10 within the placebo group. At 6 months, the mean FAAM increased from 36.3 to 73.8 of 100, and mean pain score decreased from 7.2 to 3.6 of 10 within the IBTA group. These postinjection scores were significantly better than the placebo group ( P = .01). At 12 months after injection, the IBTA group maintained significantly better function and pain than the placebo group ( P < .05). By that time, 0 (0%) and 3 (12%) patients who received IBTA and saline, respectively, underwent surgery for recalcitrant plantar fasciitis ( P < .005).
Compared with placebo saline injection, using IBTA to treat plantar fasciitis resulted in significantly better improvement in foot function and pain. IBTA also lessened the need for operative treatment of plantar fasciitis.
I, Randomized, double-blinded, placebo-controlled study.
本研究通过一项随机、对照、双盲试验,研究了肉毒杆菌毒素对足底筋膜炎的影响。
2012年至2015年期间,50例患者被诊断为足底筋膜炎。将25例患者随机分为两组,分别接受因卡肉毒杆菌毒素A(IBTA)或生理盐水注射到患足。注射前后的功能和疼痛分别采用足踝能力测量量表(FAAM)和视觉模拟量表(VAS)进行评分。所有50例随机接受安慰剂或IBTA治疗的研究患者在注射后6个月和12个月进行随访。
在6个月时,安慰剂组的FAAM平均得分从100分中的35.9分提高到40.9分,平均疼痛评分从10分中的8.4分降至7.9分。在6个月时,IBTA组的FAAM平均得分从100分中的36.3分提高到73.8分,平均疼痛评分从10分中的7.2分降至3.6分。这些注射后的评分显著优于安慰剂组(P = 0.01)。注射后12个月,IBTA组的功能和疼痛状况仍显著优于安慰剂组(P < 0.05)。此时,接受IBTA和生理盐水治疗的患者中,分别有0例(0%)和3例(12%)因顽固性足底筋膜炎接受了手术治疗(P < 0.005)。
与安慰剂生理盐水注射相比,使用IBTA治疗足底筋膜炎可显著改善足部功能和疼痛状况。IBTA还减少了足底筋膜炎手术治疗的需求。
I级,随机、双盲、安慰剂对照研究。