Data_Sheet_1_Using a Robot to Treat Non-specific Low Back Pain: Results From a Two-Arm, Single-Blinded, Randomized Controlled Trial.docx

Non-specific low back pain (NSLBP) affects many people and represents a high cost for health care. Manual pressure release of myofascial trigger points is used to treat NSLBP and is very effective but difficult to standardize since it is provided by different therapists, which also suffer musculoskeletal complications from this highly repetitive activity. A robot designed for this purpose may help in reducing these problems. Here, we present data from a two-arm, single-blinded, randomized controlled clinical trial evaluating the efficiency of a therapeutic massage robot (ADAMO) in reducing NSLBP (clinicaltrials.gov, registration number: NCT04882748). Forty-four patients were randomly distributed into the two arms of the study (robot vs. control). A physician filled the Oswestry disability index (ODI) before starting the treatment and at the end of it, in a blind fashion. In addition, patients filled a visual analogue scale (VAS) after each of the 10 treatment sessions. The ODI and the VAS were analyzed as the primary and secondary outcome measures. Both treatments (robot and control) resulted in a significantly lower ODI (p < 0.05). On the other hand, robot-treated patients significantly reduced their VAS levels (p = 0.0001) whereas control treatment did not reach statistical significance. Patients of both sexes obtained similar benefits from either treatment. Overweight patients (body mass index ≥ 25kg/m2) in the robot arm benefited more from the treatment (p = 0.008) than patients with normal weight. In conclusion, the ADAMO robot is, at least, as efficient as regular treatment in reducing low back pain, and may be more beneficial for specific patients, such as those with excessive weight.

非特异性下腰痛（NSLBP）广泛影响众多人群，并给医疗保健带来高昂的经济负担。肌筋膜扳机点的手法释放被用于治疗NSLBP，尽管其疗效显著，但由于不同治疗师提供的方式各异，且治疗师自身亦因这种高度重复性的活动而遭受骨骼肌肉并发症，因此标准化难度较大。为此目的设计的机器人或许能够帮助减轻这些问题。在本研究中，我们呈现了一项双臂、单盲、随机对照的临床试验数据，旨在评估治疗按摩机器人（ADAMO）在降低NSLBP方面的效率（临床试验注册号：NCT04882748）。44名患者被随机分配到研究的两个组别（机器人组与对照组）。在治疗开始前及结束时，一位医生以盲法的方式填写了奥斯韦斯特里功能障碍指数（ODI）。此外，患者在每次治疗的10个治疗疗程后填写了视觉模拟评分（VAS）。ODI和VAS被用作主要和次要的结局指标。两种治疗方法（机器人治疗和对照组）均导致ODI显著降低（p < 0.05）。另一方面，接受机器人治疗的患者显著降低了他们的VAS评分（p = 0.0001），而对照组治疗则未达到统计学意义。无论是男性还是女性患者，从两种治疗中均获得了相似的好处。在机器人治疗组中，体重过重（体重指数≥25kg/m2）的患者比正常体重患者从治疗中获益更多（p = 0.008）。总之，ADAMO机器人至少与常规治疗在减轻腰痛方面同样有效，并且可能对某些特定患者（如体重过重者）更为有益。