Carlesso Lisa C, Modarresi Shirin, Pearson Neil, Madden Kim, Fahnestock Margaret, Bennell Kim L, Neogi Tuhina, Shafiee Erfan
Michael DeGroote Institute for Pain Research and Care (IPRC), McMaster University, Hamilton, ON, Canada.
School of Rehabilitation Science, Faculty of Health Science, McMaster University, Hamilton, ON, Canada.
Osteoarthr Cartil Open. 2025 Jul 9;7(3):100646. doi: 10.1016/j.ocarto.2025.100646. eCollection 2025 Sep.
To determine the feasibility of conducting a full-scale randomized controlled trial to test the effectiveness of pain informed movement (PIM) (includes mind-body techniques, neuromuscular strengthening exercises (NEMEX) and pain neuroscience education), compared to NEMEX and standard education in people with knee osteoarthritis (KOA).
Adults ≥40 years with KOA were randomized to a twice weekly in-person group program for 8 weeks. Education was delivered through weekly videos. Recruitment, follow-up, adherence (attendance), compliance to home exercises, burden of procedures as well as patient-reported clinical outcomes, quantitative sensory tests, the sit to stand test, and serum levels of brain derived neurotrophic factor and nerve growth factor were assessed before and immediately after treatment. Focus groups were conducted post intervention.
210 people were screened for eligibility. 69 (33 %) were randomized and 59 (28 PIM, 31 NEMEX; 86 %) completed the trial. The primary outcome of follow up rate was met along with all other a priori criteria. There was high acceptability of both interventions (≥86 %), and perceived low burden of procedures (≥80 %). Only minor adverse events were reported. Secondary outcomes improved across most clinical measures in both groups with the PIM group showing clinically important improvement in pain. Focus group feedback suggests the need to consider an alternative format to video delivery of the education content.
This pilot RCT indicates that a full trial is feasible and warranted to test the effectiveness of PIM versus NEMEX and standard education with the potential to provide mechanistic insights based on nervous system modulation.
确定开展一项全面随机对照试验的可行性，以测试疼痛知情运动（PIM）（包括身心技术、神经肌肉强化锻炼（NEMEX）和疼痛神经科学教育）与NEMEX及标准教育相比，对膝骨关节炎（KOA）患者的有效性。
年龄≥40岁的KOA成人被随机分配到一个每周两次的面对面小组项目中，为期8周。通过每周的视频进行教育。在治疗前和治疗后立即评估招募情况、随访情况、依从性（出勤情况）、家庭锻炼的依从性、程序负担以及患者报告的临床结局、定量感觉测试、坐立试验，以及脑源性神经营养因子和神经生长因子的血清水平。干预后进行焦点小组讨论。
对210人进行了资格筛查。69人（33%）被随机分组，59人（28人接受PIM，31人接受NEMEX；86%）完成了试验。随访率的主要结局以及所有其他先验标准均达到。两种干预措施的可接受性都很高（≥86%），且感觉程序负担较低（≥80%）。仅报告了轻微不良事件。两组在大多数临床指标上的次要结局均有所改善；PIM组在疼痛方面显示出具有临床意义的改善。焦点小组反馈表明，需要考虑采用视频以外的其他形式来提供教育内容。
这项初步随机对照试验表明，进行全面试验是可行且有必要的，以测试PIM与NEMEX及标准教育相比的有效性，并有可能基于神经系统调节提供机制性见解。
