Sammons Travis, Gair Kirk, Silverman Robert G, Shanks Steve
Erchonia Corporation, Melbourne, FL, USA.
Clinical Study Site, Laser Chiropractic, West Covina, CA, USA.
Evid Based Complement Alternat Med. 2023 Oct 4;2023:6672019. doi: 10.1155/2023/6672019. eCollection 2023.
The effect of low-level laser therapy with high photon energy wavelengths, green and violet, for treating chronic musculoskeletal pain was examined in the first-ever clinical trial of its kind. Participants ( = 43) underwent a single 13-minute laser session. The primary measure of effectiveness was the change in initial visual analog pain (VAS) scores observed three minutes posttreatment. The success of a participant was defined in advance as a reduction of ≥30% in VAS scores, while the success of the study was predetermined as achieving a 65 ± 5% success rate among individual participants. Results demonstrated subjects' VAS pain scores decreased from 71.79 to 34.02 ( < 0.0001), while most participants in the study (81.4%) achieved a ≥30% decrease in pain scores. The findings from this clinical investigation provided substantial support for the first Food and Drug Administration clearance (K221987) for the combined application of green and violet lasers.
在同类首次临床试验中,研究了采用高光子能量波长的绿色和紫色低强度激光疗法治疗慢性肌肉骨骼疼痛的效果。参与者(n = 43)接受了一次13分钟的激光治疗。有效性的主要衡量指标是治疗后三分钟观察到的初始视觉模拟疼痛(VAS)评分的变化。预先将参与者疼痛评分降低≥30%定义为成功,而该研究的成功则预先设定为在个体参与者中达到65±5%的成功率。结果显示,受试者的VAS疼痛评分从71.79降至34.02(P < 0.0001),同时该研究中的大多数参与者(81.4%)疼痛评分降低≥30%。这项临床研究的结果为美国食品药品监督管理局首次批准(K221987)绿色和紫色激光联合应用提供了有力支持。