Fernandes Walkyria Vilas Boas, Blanco Cleofás Rodríguez, Politti Fabiano, de Cordoba Lanza Fernanda, Lucareli Paulo Roberto Garcia, Corrêa João Carlos Ferrari
Doctoral Program in Rehabilition Sciences, Nove de Julho University (UNINOVE), São Paulo, Brazil.
Federal University of Mato Grosso (UFMT), Rondonópolis, Brazil.
Trials. 2018 Mar 2;19(1):151. doi: 10.1186/s13063-018-2532-8.
The aim of the proposed study is to analyze the effect of a six-week osteopathic visceral manipulation (OVM) program on the flexion-relaxation phenomenon in individuals with non-specific chronic low back pain (LBP) and functional constipation.
METHODS/DESIGN: An assessor-blinded, two-arm, randomized, placebo-controlled trial will be conducted. The sample will comprise 76 individuals with non-specific chronic LBP who have functional intestinal constipation, aged 18-65 years. The participants will be randomly allocated to two groups: (1) OVM and (2) sham OVM (SOVM). Evaluations will involve an interview, the Oswestry Disability Index, Fear-Avoidance Beliefs Questionnaire, functional constipation according to Rome III criteria, Biering-Sorensen test to normalize electromyographic (EMG) data, T12-L1 paraspinal level of the EMG signal during the flexion-relaxation phenomenon, 11-point numeric pain rating scale and fingertip-to-floor test. OVM and SOVM will be performed once per week for six weeks. Group 1 will receive OVM for 15 min and Group 2 will receive a sham visceral technique. Evaluations will be performed before and after the first session, after six weeks of treatment, and three months after randomization (follow-up). The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05). The limitation of the study is that the therapist will not be blinded.
This will be the first trial to analyze the clinical response and electromyographic signals during the flexion-relaxation phenomenon after OVM.
Brazilian Clinical Trial Registry, RBR-7sx8j3 . Registered on 26 October 2017.
本研究的目的是分析为期六周的整骨内脏手法治疗（OVM）方案对非特异性慢性腰痛（LBP）和功能性便秘患者屈伸放松现象的影响。
方法/设计：将进行一项评估者盲法、双臂、随机、安慰剂对照试验。样本将包括76名年龄在18 - 65岁之间、患有功能性肠道便秘的非特异性慢性LBP患者。参与者将被随机分为两组：（1）OVM组和（2）假OVM组（SOVM）。评估将包括访谈、Oswestry功能障碍指数、恐惧回避信念问卷、根据罗马III标准评估的功能性便秘、用于标准化肌电图（EMG）数据的Biering-Sorensen试验、屈伸放松现象期间T12 - L1椎旁肌水平的EMG信号、11点数字疼痛评分量表和指尖触地试验。OVM和SOVM将每周进行一次，共六周。第一组将接受15分钟的OVM治疗，第二组将接受假内脏手法治疗。评估将在第一次治疗前和治疗后、治疗六周后以及随机分组后三个月（随访）进行。将在5%的显著性水平（p≤0.05）下对研究结果进行统计学分析。本研究的局限性在于治疗师不会被设盲。
这将是第一项分析OVM后屈伸放松现象期间临床反应和肌电信号的试验。
巴西临床试验注册中心，RBR - 7sx8j3。于2017年10月26日注册。
