Effects of Photobiomodulation Therapy on Inflammatory Mediators in Patients With Chronic Non-specific Low Back Pain: a Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Levels of prostaglandin E2 (PGE2)
研究概览
简要总结
Low back pain (LBP) is ranked as one of the most prevalent health conditions. It is likely that some inflammatory mediators could be associated with pain and disability in these patients. Photobiomodulation therapy (PBMT) is a non-pharmacological therapy often used in patients with LBP that decrease release of inflammatory mediators and accelerate muscle repair in different muscle skeletal conditions, as mechanisms of action. The present research project aims to evaluate the effects of PBMT on systemic levels of inflammatory markers and levels of pain intensity in patients with chronic non-specific low back pain.
详细描述
This is a randomized, triple-blinded (therapist, assessor and patient), placebo-controlled trial, with voluntary patients with non-specific chronic low back pain.
Eighteen patients will be randomly allocated to two treatment groups: Placebo or PBMT and one single session of treatment will be provided.
The data will be collected by a blinded assessor and the outcomes of interest it will be levels of inflammatory markers and pain intensity and it will be collected at baseline and 15 minutes after the single session of treatment.
The statistical analysis will follow the intention-to-treat principles. The findings will be tested for their normality using the Shapiro-Wilk test. Parametric data will be expressed as mean and standard deviation and non-parametric data as median and respective upper and lower limits. Parametric data will be analyzed by two-way repeated measures analysis of variance (ANOVA; time versus experimental group) with post-hoc Bonferroni correction. Non-parametric data will be analyzed using the Friedman test and, secondarily, the Wilcoxon signed-rank test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The mode of intervention (active or placebo PBMT) will be coded by an independent researcher. The randomization schedule will contain only codes (not the actual intervention). The output from the PBMT device is exactly the same from either the active or the placebo interventions. These features will guarantee that participants, therapists and outcomes assessor will be blinded to the treatment arms.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 month);
- •with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale;
- •aged between 18 and 65 years;
排除标准
- •evidence of nerve root compromise (i.e. one or more of motor, reflex or sensation deficit);
- •serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases);
- •serious cardiovascular and metabolic diseases;
- •previous back surgery;
- •pregnancy.
- •severe skin diseases (eg. skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
研究组 & 干预措施
Placebo PBMT
Application of PBMT (Photobiomodulation Therapy) without any dose (0 Joule).
干预措施: Placebo PBMT (Device)
Active PBMT
Application of PBMT (Photobiomodulation Therapy) active.
干预措施: Active PBMT (Device)
结局指标
主要结局
Levels of prostaglandin E2 (PGE2)
时间窗: 15 minutes after the treatment
Inflammation will be measured by blood samples
次要结局
- Levels of interleukin-6 (IL-6)(15 minutes after the treatment)
- Levels of tumor necrosis factor alpha (TNF-a)(15 minutes after the treatment.)
- Pain Intensity(15 minutes after the treatment.)
研究者
Shaiane da Silva Tomazoni
Postdoctoral fellow and visiting researcher
Universidade Cidade de Sao Paulo