Carroll Aine, Barnes Mike, Comiskey Catherine
National Rehabilitation Hospital, Dublin, Ireland.
Clin Rehabil. 2008 Jun;22(6):513-9. doi: 10.1177/0269215507086778.
To investigate the effectiveness of botulinum toxin in preventing the development of chronic whiplash-associated disorder.
Prospective, randomized, placebo-controlled double-blind study.
Regional Neurological Rehabilitation Centre with participants being at home.
Thirty-seven patients with whiplash-associated disorder who remained symptomatic two months after injury.
Patients were randomized to receive either 250 units botulinum toxin type A (Dysport) or placebo (normal saline). Four trigger points were injected with 0.625 mL of injectant.
Tenderness to palpation scores, visual analogue pain scale, Vernon-Mior Neck Pain and Disability Index and cervical range of motion. Follow-up assessments were carried out at four weeks and three months after treatment.
Twenty participants received botulinum toxin and 17 received placebo. Both groups showed a tendency towards improvement in pain scores, Vernon-Mior Index and range of motion at four weeks and three months, with the changes being more pronounced in the toxin group. The change in Vernon-Mior Index in the toxin group was both statistically and clinically significant (i.e. a change of score of > or = 5 from baseline to follow-up). Group comparisons did not meet statistical significance.
The improvements in outcome measures suggest that botulinum toxin type A may have a role to play in the management of whiplash-associated disorder but larger studies are required to clarify the situation.
研究肉毒杆菌毒素在预防慢性挥鞭样损伤相关疾病发展中的有效性。
前瞻性、随机、安慰剂对照双盲研究。
地区神经康复中心,参与者在家中。
37例挥鞭样损伤相关疾病患者,受伤两个月后仍有症状。
患者被随机分为两组,分别接受250单位A型肉毒杆菌毒素(Dysport)或安慰剂(生理盐水)。四个触发点各注射0.625 mL注射剂。
触痛评分、视觉模拟疼痛量表、Vernon-Mior颈部疼痛和功能障碍指数以及颈椎活动范围。治疗后四周和三个月进行随访评估。
20名参与者接受肉毒杆菌毒素治疗,17名接受安慰剂治疗。两组在四周和三个月时疼痛评分、Vernon-Mior指数和活动范围均有改善趋势,毒素组变化更明显。毒素组Vernon-Mior指数的变化在统计学和临床上均有显著意义(即从基线到随访评分变化≥5分)。组间比较无统计学意义。
观察指标的改善表明,A型肉毒杆菌毒素可能在挥鞭样损伤相关疾病的治疗中发挥作用,但需要更大规模的研究来明确情况。