Pasquini Guido, Cecchi Francesca, Bini Christian, Molino-Lova Raffaello, Vannetti Federica, Castagnoli Chiara, Paperini Anita, Boni Roberta, Macchi Claudio, Crusco Biase, Ceppatelli Simone, Corigliano Alvaro
Don Gnocchi Foundation, Florence, Italy -
Eur J Phys Rehabil Med. 2016 Oct;52(5):618-629. Epub 2016 May 4.
Bracing therapy for patients with adolescent idiopathic scoliosis (AIS) continues to be a controversial issue. As a consequence, to achieve an adequate level of evidence, there is a strong need for specific studies conducted according to standard outcome and management criteria.
To assess the outcomes of a modified version of the Cheneau brace, ("Cheneau-P") in patients with AIS, based on SRS and SOSORT criteria.
Retrospective study.
Scoliosis Unit of a Clinical Center.
Sixty-seven patients, 56 females and 11 males.
Inclusion criteria were: diagnosis of AIS, age ≥10 years, Risser Score 0-2, Cobb degrees 20-40, no previous treatment, beginning of brace treatment within 1 year after menarche and minimum 2-year follow-up. According to SRS criteria, bracing outcomes were classified, as follows: "improved" (reduction of the curve ≥6°), "unchanged" (5° curve progression or reduction), "worsened" (≥6° curve progression), and "over 45°" (curve exceeding 45° or undergone surgery during the follow-up). The outcomes "improved" and "unchanged" were considered as successful outcomes. Groups and related subgroups were created according to curve type (thoracic, thoraco-lumbar, lumbar and double major) and magnitude (20°-30°; 30°-40°) and to skeletal age (Risser score 0, 1, 2). A separate analysis was also performed on the 37 patients, 30 females and 7 males, who completely fulfilled the SRS eligibility criteria, showing spinal curves between 25 and 40 Cobb degrees.
In the whole group SRS outcome after bracing treatment was successful in 93% and in 81% of patients, at per protocol (PP) and intention to treat (ITT) analysis, respectively, the latter also including drop-outs as worst outcomes. Cobb angles significantly decreased in all subgroups except in patients showing double major curves, lower curve magnitude (20-30°) and Risser score 2. Rib humps and balance rate also significantly improved in the whole sample (12.78±4.54 at T0 vs. 6.83±4.33 at T1 P<0.001; 60% at T0 vs. 94% at T1 P<0.001, respectively). In the subgroup that completely fulfilled the SRS eligibility criteria, the outcome was successful in 92% and 83% of patients, at PP and ITT analysis, respectively, the latter also including, even in this case, drop-outs as worst outcomes.
This study shows that in patients with AIS the treatment with the "Cheneau-P" brace is associated with a remarkably high rate of successful outcomes, both in the whole sample and in the subgroup of patients completely fulfilling the SRS criteria.
The "Cheneau-P" brace proved effective as a conservative treatment for AIS by stabilizing curve progression and limiting the need for surgical treatment.
青少年特发性脊柱侧凸(AIS)患者的支具治疗一直是一个有争议的问题。因此,为了获得足够的证据水平,迫切需要根据标准的结果和管理标准进行具体研究。
根据SRS和SOSORT标准,评估改良版的施诺支具(“Cheneau-P”)对AIS患者的治疗效果。
回顾性研究。
一家临床中心的脊柱侧弯治疗单元。
67例患者,其中56例女性,11例男性。
纳入标准为:诊断为AIS,年龄≥10岁,Risser评分0-2,Cobb角20-40度,既往未接受过治疗,月经初潮后1年内开始支具治疗且随访至少2年。根据SRS标准,支具治疗结果分类如下:“改善”(侧弯减少≥6°)、“不变”(侧弯进展或减少5°)、“恶化”(侧弯进展≥6°)和“超过45°”(随访期间侧弯超过45°或接受手术)。“改善”和“不变”的结果被视为成功结果。根据侧弯类型(胸段、胸腰段、腰段和双主弯)、严重程度(20°-30°;30°-40°)和骨骼年龄(Risser评分0、1、2)创建组和相关亚组。还对37例完全符合SRS纳入标准的患者(30例女性和7例男性)进行了单独分析,这些患者的脊柱侧弯Cobb角在25至40度之间。
在整个研究组中,按照符合方案(PP)分析,支具治疗后SRS结果成功的患者占93%;按照意向性分析(ITT),成功的患者占81%,ITT分析将失访患者视为最差结果。除双主弯、侧弯程度较低(20-30°)且Risser评分为2的患者外,所有亚组的Cobb角均显著减小。整个样本的肋骨隆起和平衡率也显著改善(T0时为12.78±4.54,T1时为6.83±4.33,P<0.001;T0时为60%,T1时为94%,P<0.001)。在完全符合SRS纳入标准的亚组中,按照PP分析,结果成功的患者占92%;按照ITT分析,成功的患者占83%,ITT分析在该亚组中同样将失访患者视为最差结果。
本研究表明,对于AIS患者,“Cheneau-P”支具治疗在整个样本以及完全符合SRS标准的亚组中均具有非常高的成功治疗率。
“Cheneau-P”支具被证明是一种有效的AIS保守治疗方法,可稳定侧弯进展并减少手术治疗的需求。