Ibrahim Aminu A, Akindele Mukadas O, Ganiyu Sokunbi O
Department of Physiotherapy, Faculty of Allied Health Sciences, Bayero University Kano, Kano State, Nigeria.
J Exerc Rehabil. 2018 Oct 31;14(5):851-863. doi: 10.12965/jer.1836348.174. eCollection 2018 Oct.
This pilot randomized clinical trial assessed the feasibility of implementing motor control exercise (MCE) and patient education (PE) program for the management of chronic low back pain (CLBP) in a low resource rural Nigerian community. Thirty patients with CLBP were recruited and randomly assigned to MCE, PE, or MCE plus PE groups. The MCE program was provided twice a week while the PE program was provided once a week all for 6 weeks. Feasibility was assessed through recruitment rate, treatment compliance, retention/dropout rate, report of adverse events, perceived helpfulness, overall satisfaction, and clinical outcome of pain (numeric pain rating scale) and functional disability (Oswestry Disability Index). Many patients were willing to participate in the study and the recruitment rate was 77%. Treatment compliance in all the three groups were >65% for supervised treatment sessions and <50% for prescribed home program. Retention rate was high and greater overall satisfaction with the interventions was reported. Compared with the baseline, all the three groups improved significantly in pain and disability (<0.05) after 6 weeks. Pairwise comparison revealed that the MCE plus PE group was superior to the PE group for pain and to the MCE for disability (<0.05), with large effect size. It was concluded that the designed interventions are promising and conducting a full-scale randomized clinical trial in the future is feasible to confirm the effectiveness of the interventions for the management CLBP in rural Nigeria. (Trial registration: ClinicalTrials.gov, NCT03398174).
这项试点随机临床试验评估了在尼日利亚农村资源匮乏社区实施运动控制锻炼(MCE)和患者教育(PE)计划以管理慢性下腰痛(CLBP)的可行性。招募了30名CLBP患者,并将他们随机分配到MCE组、PE组或MCE加PE组。MCE计划每周提供两次,PE计划每周提供一次,均为期6周。通过招募率、治疗依从性、留存/退出率、不良事件报告、感知帮助程度、总体满意度以及疼痛(数字疼痛评分量表)和功能障碍(奥斯威斯利功能障碍指数)的临床结果来评估可行性。许多患者愿意参与研究,招募率为77%。三组中监督治疗课程的治疗依从性均>65%,规定的家庭计划的治疗依从性均<50%。留存率很高,并且报告称对干预措施的总体满意度更高。与基线相比,所有三组在6周后疼痛和功能障碍方面均有显著改善(<0.05)。两两比较显示,MCE加PE组在疼痛方面优于PE组,在功能障碍方面优于MCE组(<0.05),效应量较大。得出的结论是,所设计的干预措施很有前景,未来进行全面的随机临床试验以确认这些干预措施对尼日利亚农村CLBP管理的有效性是可行的。(试验注册:ClinicalTrials.gov,NCT03398174)