Faculty of Physical Education and Sport Sciences, Department of Biomechanics and Sport Injuries, Kharazmi University, Tehran, Iran.
School of Physiotherapy, University of Verona, Verona, Italy.
PLoS One. 2024 Nov 4;19(11):e0309679. doi: 10.1371/journal.pone.0309679. eCollection 2024.
Chronic low back pain (CLBP) is a prevalent health condition worldwide. Several therapeutic interventions aim to improve CLBP. Pain Neuroscience Education (PNE) helps patients better understand their pain from biological and physiological perspectives, which clinicians use to reduce pain and disability in patients with chronic musculoskeletal conditions. Neuromuscular exercises (NMS) are also treatments adopted in CLBP. This study will investigate whether PNE combined with an NMS program improves pain, functional and psychological outcomes more than NMS alone in patients with CLBP.
In this single-blind randomized controlled trial, 60 patients (male and female; age range, 30-60 years) diagnosed with CLBP will be randomly assigned to one of the following groups: (1) PNE plus NMS (n = 30; 24 sessions of PNE plus NMS in a total of 8 weeks, 3 each week), and (2) NMS alone (n = 30; 24 sessions of NMS sessions in a total of 8 weeks, 3 each week). Outcome assessors will be blinded to the group allocation. The primary outcome will be pain. Secondary outcomes will be disability, fear-avoidance beliefs about work and physical activity, self-efficacy, exercise anxiety, and kinesiophobia. Outcomes will be assessed at baseline, after 8 weeks of intervention, and 6 months post-intervention.
The findings of this RCT will help shed light on new treatment strategies to address the biopsychosocial dimensions of CLBP. The study protocol will be conducted in a clinical setting, offering the opportunity for future implementation in healthcare systems. Moreover, it will help clarify whether a combined treatment (PNE with NMS) is more effective than NMS alone for improving pain, functional and psychological outcomes in CLBP.
Study registration: The study was prospectively registered in the Iranian Registry of Clinical Trials-IRCT20190427043384N2 (https://www.irct.ir/trial/69146). Registered on March 17, 2023.
慢性下背痛（CLBP）是一种全球普遍存在的健康问题。有几种治疗干预措施旨在改善 CLBP。疼痛神经科学教育（PNE）帮助患者从生物学和生理学角度更好地理解他们的疼痛，临床医生使用这种方法来减轻慢性肌肉骨骼疾病患者的疼痛和残疾。神经肌肉运动（NMS）也是 CLBP 的治疗方法。本研究将调查 PNE 与 NMS 方案相结合是否比单独使用 NMS 更能改善 CLBP 患者的疼痛、功能和心理结果。
在这项单盲随机对照试验中，将 60 名（男性和女性；年龄 30-60 岁）诊断为 CLBP 的患者随机分为以下两组之一：（1）PNE 加 NMS（n = 30；PNE 加 NMS 共 24 次，每周 3 次，共 8 周），和（2）NMS 单独组（n = 30；NMS 共 24 次，每周 3 次，共 8 周）。结果评估者将对分组情况不知情。主要结果将是疼痛。次要结果将是残疾、对工作和体育活动的恐惧回避信念、自我效能、运动焦虑和运动恐惧症。结果将在基线、干预 8 周后和干预后 6 个月进行评估。
这项 RCT 的结果将有助于阐明新的治疗策略，以解决 CLBP 的生物心理社会维度。该研究方案将在临床环境中进行，为未来在医疗保健系统中实施提供机会。此外，它将有助于澄清联合治疗（PNE 与 NMS）是否比单独使用 NMS 更能改善 CLBP 的疼痛、功能和心理结果。
该研究在伊朗临床试验注册中心进行了前瞻性注册-IRCT20190427043384N2（https://www.irct.ir/trial/69146）。于 2023 年 3 月 17 日注册。
