Department of Physiotherapy, Faculty of Allied Health Sciences, College of Health Sciences, Bayero University, Kano, Kano State, P.M.B 3011, Nigeria.
Department of Physiotherapy, National Orthopedic Hospital, Dala, Kano, Kano State, P.M.B 3087, Nigeria.
Trials. 2022 Jan 6;23(1):20. doi: 10.1186/s13063-021-05952-9.
Structural impairment of the lumbar multifidus muscle, such as reduced cross-sectional area, is evident among individuals with chronic low back pain. Real-time ultrasound imaging (RUSI) biofeedback has been reported to improve preferential activation of as well as retention in the ability to activate the lumbar multifidus muscle during lumbar stabilization exercises (LSE). However, evidence of the effectiveness of this treatment approach in individuals with non-specific chronic low back pain (NCLBP) is still limited. The purpose of this study is, therefore, to determine the effectiveness of LSE with RUSI biofeedback on lumbar multifidus muscle cross-sectional area in individuals with NCLBP.
METHODS/DESIGN: This study is a prospective, single-center, assessor-blind, three-arm, parallel randomized controlled trial to be conducted at National Orthopedic Hospital, Kano State, Nigeria. Ninety individuals with NCLBP will be randomized in a 1:1:1: ratio to receive LSE, LSE with RUSI biofeedback, or minimal intervention. All participants will receive treatment twice weekly for 8 weeks. The primary outcome will be the lumbar multifidus muscle cross-sectional area. The secondary outcomes will include pain (Numerical Pain Rating Scale), functional disability (Roland-Morris Disability Questionnaire), and quality of life (12-Item Short-Form Health Survey). All outcomes will be assessed at baseline, 8 weeks post-intervention, and 3 months follow-up.
To our knowledge, this study will be the first powered randomized controlled trial to compare the effectiveness of LSE training with and without RUSI biofeedback in individuals with NCLBP. The outcome of the study may provide evidence for the effectiveness of LSE with RUSI biofeedback on enhancing the recovery of the lumbar multifidus muscle in individuals with NCLBP.
Pan African Clinical Trials Registry ( PACTR201801002980602) . Registered on January 16, 2018.
慢性下腰痛患者的腰椎多裂肌结构损伤，如横截面积减少，较为明显。实时超声成像（RUSI）生物反馈已被报道可改善腰椎稳定运动（LSE）中腰椎多裂肌的优先激活和保持激活能力。然而，在非特异性慢性下腰痛（NCLBP）患者中，这种治疗方法的有效性证据仍然有限。因此，本研究旨在确定 RUSI 生物反馈下的 LSE 对 NCLBP 患者腰椎多裂肌横截面积的有效性。
方法/设计：这是一项在尼日利亚卡诺州国家骨科医院进行的前瞻性、单中心、评估者盲法、三臂、平行随机对照试验。90 名 NCLBP 患者将以 1:1:1 的比例随机分为 LSE 组、LSE+RUSI 生物反馈组和最小干预组。所有参与者将每周接受 2 次治疗，共 8 周。主要结局将是腰椎多裂肌横截面积。次要结局包括疼痛（数字疼痛评分量表）、功能障碍（Roland-Morris 残疾问卷）和生活质量（12 项简明健康调查）。所有结局将在基线、干预后 8 周和 3 个月随访时进行评估。
据我们所知，这将是第一项比较 RUSI 生物反馈下的 LSE 与无 RUSI 生物反馈下的 LSE 在 NCLBP 患者中的有效性的有力度的随机对照试验。该研究的结果可能为 RUSI 生物反馈下的 LSE 增强 NCLBP 患者腰椎多裂肌恢复提供有效性证据。
泛非临床试验注册中心（PACTR201801002980602）。于 2018 年 1 月 16 日注册。
