■慢性背痛是最普遍的疾病之一,具有很大的社会经济影响。缺乏常规使用非药物选择和与药物治疗相关的问题强调了背痛治疗中未满足的高度需求。尽管蓝光光疗已在皮肤病学中证明了疗效,关于其在背痛中使用的信息有限。
■在这个概念证明中,随机对照试验,疼痛缓解贴片(PRP)在五个疗程中在背痛部位发出蓝光30分钟。比较器装置发出绿灯5s,但佩戴30分钟。最后一次治疗后进行了随访。主要目的是证明PRP治疗的优越性,与控制装置相比,在治疗期结束时降低疼痛强度。在五个疗程中计算每组的治疗后视觉模拟量表(VAS)疼痛强度评分,并与基线进行比较。次要目标包括残疾评分(Roland-Morris残疾问卷)和安全性。
■整个分析集包括171名患者。使用PRP后疼痛强度显著降低(p<0.02),但该研究未达到其主要目标,即旨在证明在VAS量表上支持PRP有0.6cm差异的优势试验.残疾评分没有显著变化。进行亚组分析以通过患者特征如基线疼痛强度和皮肤类型来鉴定治疗反应。不出所料,安全性数据显示PRP组出现红斑和皮肤变色,而对照组未出现.
■该试验有多个局限性,需要在未来的研究中解决。尽管主要目标没有实现,这项概念验证研究提供了与在慢性背痛治疗中使用蓝光相关的重要疗效和安全性数据,以及可能支持类似器械进一步研究的关键见解.
■ClinicalTrials.gov,标识符NCT01528332。
UNASSIGNED: Chronic back pain is one of the most prevalent conditions and has a large socio-economic impact. The lack of routine use of non-pharmacological options and issues associated with pharmacological treatments underscore high unmet needs in the treatment of back pain. Although blue light phototherapy has proven efficacy in dermatology, limited information is available about its use in back pain.
UNASSIGNED: In this proof-of-concept, randomized controlled trial, a pain relief patch (PRP) delivered blue light at the site of back pain for 30 min during five treatment sessions. The comparator device delivered green light for 5 s but was worn for 30 min. A follow-up visit took place after the last treatment. The primary objective was to demonstrate the superiority of treatment by PRP, compared to the control device, in reducing pain intensity at the end of the treatment period. The post-treatment visual analog scale (VAS) pain intensity score for each group was calculated across the five treatment sessions and compared to the baseline. Secondary objectives included the disability score (Roland-Morris Disability Questionnaire) and safety.
UNASSIGNED: The full analysis set included 171 patients. A statistically significant reduction in pain intensity occurred after the use of PRP (p < 0.02), but the study did not meet its primary objective of a superiority trial aimed at demonstrating a 0.6 cm difference in favor of PRP on the VAS scale. There was no significant change in the disability scores. Subgroup analyses were performed to identify the treatment response by patient characteristics such as pain intensity at baseline and skin type. As expected, safety data showed erythema and skin discoloration in the PRP group but not in the control group.
UNASSIGNED: This trial had multiple limitations that need to be addressed in future research. Although the primary objective was not achieved, this proof-of-concept study provides important efficacy and safety data in relation to the use of blue light in the treatment of chronic back pain and key insights that may support further research on similar devices.
UNASSIGNED: ClinicalTrials.gov, identifier NCT01528332.