Department of Global Health & Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, MA 02115, USA.
Department of Physical Therapy & Rehabilitation, Harvard Medical School, Spaulding Rehabilitation Hospital, 300 First Avenue, Charleston, MA 02129, USA ; Spine Center, Newton-Wellesley Hospital, 159 Wells Avenue, Newton, MA 02459, USA.
Evid Based Complement Alternat Med. 2015;2015:813418. doi: 10.1155/2015/813418. Epub 2015 Apr 7.
Structural Integration (SI) is an alternative method of manipulation and movement education. To obtain preliminary data on feasibility, effectiveness, and adverse events (AE), 46 outpatients from Boston area with chronic nonspecific low back pain (CNSLBP) were randomized to parallel treatment groups of SI plus outpatient rehabilitation (OR) versus OR alone. Feasibility data were acceptable except for low compliance with OR and lengthy recruitment time. Intent-to-treat data on effectiveness were analyzed by Wilcoxon rank sum, n = 23 per group. Median reductions in VAS Pain, the primary outcome, of -26 mm in SI + OR versus 0 in OR alone were not significantly different (P = 0.075). Median reductions in RMDQ, the secondary outcome, of -2 points in SI + OR versus 0 in OR alone were significantly different (P = 0.007). Neither the proportions of participants with nor the seriousness of AE were significantly different. SI as an adjunct to OR for CNSLBP is not likely to provide additional reductions in pain but is likely to augment short term improvements in disability with a low additional burden of AE. A more definitive trial is feasible, but OR compliance and recruitment might be challenging. This trial is registered with ClinicalTrials.gov (NCT01322399).
结构整合（SI）是一种替代的手法和运动教育方法。为了获得关于可行性、有效性和不良事件（AE）的初步数据，将来自波士顿地区的 46 名慢性非特异性下腰痛（CNSLBP）的门诊患者随机分为 SI 加门诊康复（OR）组与 OR 单独治疗组。可行性数据是可以接受的，只是 OR 的依从性低和招募时间长。通过 Wilcoxon 秩和检验对有效性的意向治疗数据进行分析，每组 n = 23。SI + OR 组的 VAS 疼痛主要结局的中位数降低 -26mm，而 OR 单独组为 0mm，两组间差异无统计学意义（P = 0.075）。SI + OR 组的 RMDQ 次要结局的中位数降低 2 分，而 OR 单独组为 0 分，两组间差异有统计学意义（P = 0.007）。AE 的参与者比例和严重程度均无显著差异。SI 作为 CNSLBP 的 OR 辅助治疗不太可能提供疼痛的额外缓解，但可能会增加短期残疾改善，而 AE 的额外负担较低。进行更明确的试验是可行的，但 OR 的依从性和招募可能具有挑战性。该试验在 ClinicalTrials.gov 注册（NCT01322399）。
