Effects of Photobiomodulation Therapy (LASER) Associated With Motor Control Exercises for Chronic Non-specific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 148
- 试验地点
- 3
- 主要终点
- Pain intensity
研究概览
简要总结
Non-specific low back pain (LBP) is a very prevalent health condition and is highly associated with disability worldwide. There is evidence that patients with non-specific LBP may have impairments in the control of postural muscles. In this way, motor control exercises (MCE) may be an interesting alternative in the treatment of patients with non-specific LBP. In addition, the association of MCE and photobiomodulation therapy (PBMT) may potentiate its benefits, since PBMT has ergogenic effects. Therefore, the aim of this study is to evaluate the ergogenic effects of PBMT, using low-level laser therapy, when associated with MCE in patients with chronic non-specific low back pain.
详细描述
This is a randomized, triple-blind (patients, therapists, outcome assessors), placebo-controlled trial, with voluntary patients with chronic non-specific low back pain. One hundred and forty-eight patients will be randomly allocated to two treatment groups: Placebo PBMT associated with MCE or Active PBMT associated with MCE. Treatment will be performed twice a week (on non-consecutive days), for 6 weeks, yielding 12 treatment sessions. Placebo PBMT or Active PBMT will be applied before the MCE protocol.
The clinical outcomes will be obtained at the end of treatment (6 weeks), one month after the end of treatment, 3, 6 and 12 months after randomization. The biochemical outcome will be obtained only after the end of treatment. The remaining outcomes will be obtained after the end of treatment, one month after the end of treatment, 3, 6 and 12 months after randomization.
The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated using two-way repeated measures ANOVA.
The project was also approved by the Research Ethics Committee from Universidade Nove de Julho, under the number 5.289.714.
Board Affiliation: Comissão Nacional de Ética em Pesquisa (CONEP) Phone: +55113385-9010 - Email: comitedeetica@uninove.br Address: Vergueiro nº 235/249. Liberdade, Sao Paulo, Sao Paulo, Brazil
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)
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 seeking care for 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;
- •able to read Portuguese.
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);
- •patients with severe skin diseases (eg, skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
- •decompensated severe cardiovascular and metabolic diseases;
- •previous back surgery;
- •patients with cancer;
- •body mass index (BMI) ≥
- •pregnancy.
结局指标
主要结局
Pain intensity
时间窗: At the end of treatment (6 weeks after randomization)
Pain intensity will be measured by Pain Numerical Rating Scale that evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'. Higher scores mean worse outcome.
Disability
时间窗: At the end of treatment (6 weeks after randomization)
Disability will be measured by the 24-item Roland Morris Disability Questionnaire. The questionnaire consists of 24 items that patient has to answer 'yes' or 'no'. The minimum value is 0 and the maximum value is 24. Higher scores mean worse outcome.
次要结局
- Co-interventions(At the end of treatment (6 weeks after randomization),1 month after the end of treatment, 3, 6 and 12 months after randomization)
- Disability(1 month after the end of the treatment, 3, 6 and 12 months after randomization)
- Pain intensity(1 month after the end of the treatment, 3, 6 and 12 months after randomization)
- Medication intake(At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization)
- Levels of prostaglandin E2 (PGE2)(At the end of treatment (6 weeks after randomization))
- Adverse events(At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization)
研究者
Ernesto Cesar Pinto Leal Junior
Full professor
University of Nove de Julho