Kato Tsuyoshi, Inose Hiroyuki, Ichimura Shoichi, Tokuhashi Yasuaki, Nakamura Hiroaki, Hoshino Masatoshi, Togawa Daisuke, Hirano Toru, Haro Hirotaka, Ohba Tetsuro, Tsuji Takashi, Sato Kimiaki, Sasao Yutaka, Takahata Masahiko, Otani Koji, Momoshima Suketaka, Tateishi Ukihide, Tomita Makoto, Takemasa Ryuichi, Yuasa Masato, Hirai Takashi, Yoshii Toshitaka, Okawa Atsushi
Department of Orthopaedics, Graduate School, Tokyo Medical and Dental University, Tokyo 108-0075, Japan.
Department of Orthopaedics, Ome Municipal General Hospital, Tokyo 198-0042, Japan.
J Clin Med. 2019 Feb 6;8(2):198. doi: 10.3390/jcm8020198.
While bracing is the standard conservative treatment for acute osteoporotic compression fracture, the efficacy of different brace treatments has not been extensively studied. We aimed to clarify and compare the preventive effect of the different brace treatments on the deformity of the vertebral body and other clinical results in this patient cohort. This multicenter nationwide prospective randomized study included female patients aged 65⁻85 years with acute one-level osteoporotic compression fractures. We assigned patients within four weeks of injury to either a rigid-brace treatment or a soft-brace treatment. The main outcome measure was the anterior vertebral body compression percentage at 48 weeks. Secondary outcome measures included scores on the European Quality of Life-5 Dimensions (EQ-5D), visual analog scale (VAS) for lower back pain, and the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ). A total of 141 patients were assigned to the rigid-brace group, whereas 143 patients were assigned to the soft-brace group. There were no statistically significant differences in the primary outcome and secondary outcome measures between groups. In conclusion, among patients with fresh vertebral compression fractures, the 12-week rigid-brace treatment did not result in a statistically greater prevention of spinal deformity, better quality of life, or lesser back pain than soft-brace.
虽然支具治疗是急性骨质疏松性压缩骨折的标准保守治疗方法,但不同支具治疗的疗效尚未得到广泛研究。我们旨在阐明并比较不同支具治疗对该患者队列中椎体畸形及其他临床结果的预防效果。这项多中心全国性前瞻性随机研究纳入了年龄在65至85岁之间、患有急性单节段骨质疏松性压缩骨折的女性患者。我们将受伤后四周内的患者分配至刚性支具治疗组或软性支具治疗组。主要结局指标为48周时椎体前缘压缩百分比。次要结局指标包括欧洲五维健康量表(EQ-5D)评分、下背痛视觉模拟量表(VAS)评分以及日本骨科协会下背痛评估问卷(JOABPEQ)评分。共有141例患者被分配至刚性支具组,143例患者被分配至软性支具组。两组之间的主要结局指标和次要结局指标均无统计学显著差异。总之,在新鲜椎体压缩骨折患者中,与软性支具相比,为期12周的刚性支具治疗在预防脊柱畸形、改善生活质量或减轻背痛方面并无统计学上的显著优势。