Department of Medicine, Veterans Affairs Northern California Health Care System, Martinez, California, USA.
J Pain Symptom Manage. 2010 Jan;39(1):88-99. doi: 10.1016/j.jpainsymman.2009.05.021. Epub 2009 Nov 5.
Peripheral neuropathy is one of the most common complications of diabetes.
The purpose of this study was to evaluate the effects of photon stimulation on pain intensity, pain relief, pain qualities, sensation and quality of life (QOL) in patients with painful diabetic peripheral neuropathy.
In this randomized, placebo-controlled trial, patients were assigned to receive either four photon stimulations (n=63) or four placebo (n=58) treatments. Pain intensity, pain relief, and pain qualities were assessed using self-report questionnaires. Sensation was evaluated using monofilament testing. QOL was measured using the Medical Outcomes Study Short Form-36 (SF-36). Multilevel regression model analyses were used to evaluate between-group differences in study outcomes.
No differences, over time, in any pain intensity scores (i.e., pain intensity immediately post-treatment, average pain, worst pain) or pain relief scores were found between the placebo and treatment groups. However, significant decreases, over time, were found in some pain quality scores, and significant improvements in sensation were found in patients who received the photon stimulation compared with placebo. In addition, patients in the treatment group reported significant improvements in SF-36 social functioning and mental health scores. Findings from a responder analysis demonstrated that no differences were found in the percentages of patients in the placebo and treatment groups who received 30% or more or 50% or more reduction in pain scores immediately post-treatment. However, significant differences were found in the distribution of the changes in pain relief scores, with most of the patients in the photon stimulation group reporting a slight (28.6%) to moderate (34.9%) improvement in pain relief from the beginning to the end of the study compared with no change in pain relief (43.1%) in the placebo group.
Four treatments with photon stimulation resulted in significant improvements in some pain qualities, sensation, and QOL outcomes in a sample of patients with a significant amount of pain and disability from their diabetes. A longer duration study is needed to further refine the photon stimulation treatment protocol in these chronically ill patients and to evaluate the sustainability of its effects.
周围神经病变是糖尿病最常见的并发症之一。
本研究旨在评估光刺激对伴有疼痛的糖尿病周围神经病变患者疼痛强度、疼痛缓解、疼痛性质、感觉和生活质量（QOL）的影响。
在这项随机、安慰剂对照试验中，患者被分配接受 4 次光刺激（n=63）或 4 次安慰剂（n=58）治疗。使用自我报告问卷评估疼痛强度、疼痛缓解和疼痛性质。使用单丝测试评估感觉。使用医疗结局研究短式 36 项健康调查量表（SF-36）评估 QOL。使用多层次回归模型分析评估组间研究结果的差异。
在任何疼痛强度评分（即治疗后即刻疼痛强度、平均疼痛、最剧烈疼痛）或疼痛缓解评分方面，治疗组和安慰剂组之间在任何时间点均无差异。然而，与安慰剂组相比，接受光刺激的患者的一些疼痛性质评分随时间显著下降，感觉明显改善。此外，治疗组患者的 SF-36 社会功能和心理健康评分也显著提高。应答分析的结果表明，治疗组和安慰剂组中接受疼痛评分减少 30%或更多或 50%或更多的患者比例无差异。然而，在疼痛缓解评分的变化分布上存在显著差异，与安慰剂组中疼痛缓解无变化（43.1%）相比，大多数光刺激组患者报告从研究开始到结束时疼痛缓解略有（28.6%）到中度（34.9%）改善。
在一组有大量疼痛和残疾的糖尿病患者中，4 次光刺激治疗可显著改善某些疼痛性质、感觉和 QOL 结局。需要进行更长时间的研究来进一步优化慢性疾病患者的光刺激治疗方案，并评估其效果的可持续性。
