A.E. Mann Institute for Biomedical Engineering, University of Southern California, Los Angeles, California; Queen's University, Kingston, Ontario, Canada; and Istituto Ortopedico Gaetano Pini, Milan, Italy.
Neuromodulation. 2004 Jan;7(1):38-47. doi: 10.1111/j.1525-1403.2004.04005.x.
The objective of this study was to assess the usability and safety of BION injectable neuromuscular microstimulators for therapeutic electrical stimulation (TES) to treat two conditions involving disuse atrophy: poststroke shoulder subluxation in hemiplegic subjects and knee osteoarthritis. Clinicians were provided with PC-based software to track implants and to design the exercise programs. Subjects self-administered TES (3 sessions/day, 10-30 min/session) for 6 or 12 weeks. Outcome measures included subluxation for the shoulder study and knee function and pain for the osteoarthritis study. All subjects were comfortable with the BION equipment and therapy; eight of 10 experimental subjects elected to continue treatment after the study period. Shoulder subluxation was reduced by 55% ± 54%; knee function was enhanced by 65% ± 24%; and knee pain decreased by 78% ± 18%. The devices did not migrate and did not cause inflammation or pain. Thresholds were stable over time. We conclude that the use of BION implants to exercise atrophic muscles was well-accepted and provided effective rehabilitation in these two clinical conditions.
本研究旨在评估 BION 可注射神经肌肉微刺激器用于治疗两种废用性萎缩相关疾病的治疗性电刺激 (TES) 的可用性和安全性：偏瘫患者的脑卒中后肩部半脱位和膝骨关节炎。临床医生提供了基于 PC 的软件来跟踪植入物并设计运动方案。受试者自行接受 TES（每天 3 次，每次 10-30 分钟）治疗 6 或 12 周。研究结果包括肩部研究的半脱位和膝关节功能以及骨关节炎研究的疼痛。所有受试者均对 BION 设备和治疗感到舒适；10 名实验受试者中有 8 名在研究期结束后选择继续治疗。肩部半脱位减少了 55%±54%；膝关节功能增强了 65%±24%；膝关节疼痛减轻了 78%±18%。设备没有移位，也没有引起炎症或疼痛。阈值随时间稳定。我们得出结论，BION 植入物用于锻炼萎缩肌肉的使用被广泛接受，并为这两种临床情况提供了有效的康复治疗。
