Baron Ralf, Morlion Bart, Dahan Albert, Überall Michael, von Basum Golo, Wild Imane
Division of Neurological Pain Research and Therapy, Department of Neurology, Christian-Albrechts-Universitaet Kiel, Kiel, Germany.
Leuven Centre for Algology & Pain Management, University Hospitals of Leuven, Leuven, Belgium.
Front Pain Res (Lausanne). 2024 Jul 23;5:1444401. doi: 10.3389/fpain.2024.1444401. eCollection 2024.
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.
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.
The full analysis set included 171 patients. A statistically significant reduction in pain intensity occurred after the use of PRP ( < 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.
DISCUSSION/CONCLUSION: 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.
ClinicalTrials.gov, identifier NCT01528332.
慢性背痛是最常见的病症之一，具有重大的社会经济影响。非药物治疗方法缺乏常规使用以及药物治疗相关问题凸显了背痛治疗中未满足的高需求。尽管蓝光光疗在皮肤科已被证明有效，但关于其在背痛治疗中的应用信息有限。
在这项概念验证性随机对照试验中，一种止痛贴片（PRP）在五个治疗疗程中于背痛部位照射蓝光30分钟。对照设备照射绿光5秒，但佩戴30分钟。在最后一次治疗后进行随访。主要目标是证明与对照设备相比，PRP治疗在治疗期结束时减轻疼痛强度方面的优越性。计算每组在五个治疗疗程中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（罗兰 - 莫里斯残疾问卷）和安全性。
完整分析集包括171名患者。使用PRP后疼痛强度有统计学意义的降低（<0.02），但该研究未达到其优越性试验的主要目标，即未能证明在VAS量表上PRP有0.6厘米的优势差异。残疾评分无显著变化。进行亚组分析以确定根据患者特征（如基线疼痛强度和皮肤类型）的治疗反应。正如预期的那样，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。
讨论/结论：该试验有多个局限性需要在未来研究中解决。尽管未实现主要目标，但这项概念验证性研究提供了关于蓝光治疗慢性背痛的重要疗效和安全性数据以及可能支持对类似设备进一步研究的关键见解。
ClinicalTrials.gov，标识符NCT01528332。
