Light -Emitting Diode Photobiomodulation Therapy for Non-specific Low Back Pain in Working Nurses: A Single-center, Double-blind, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 148
- 主要终点
- measure assessing change of Chair-rising time between baseline to every time points
研究概览
简要总结
Background: Low back pain (LBP) affects approximately 51-57% of hospital nurses and nurses' aides in Europe. New high-risk groups include home- and long-term-care nurses and physiotherapists. A number of European countries are experiencing a shortage of healthcare workers. Light therapy has been shown to be an effective treatment for various musculoskeletal disorders, including lateral epicondylitis, temporomandibular joint pain, carpal tunnel syndrome, and delayed-onset muscle soreness. A systematic review and meta-analysis demonstrated that low-level laser therapy is an effective method for relieving non-specific chronic low back pain (NSCLBP). However, the efficacy of light-emitting diode (LED) therapy for NSCLBP is disputed. This study aims to evaluate the effect of LED therapy on NSCLBP.
Methods and analysis: The investigators conducted a prospective, double-blind, randomized placebo-controlled trial of 148 patients with NSCLBP. The patients were randomly assigned to two groups: intervention group, where patients received LED photobiomodulation therapy three times a week for 2 weeks, and the control group, where patients had sham treatment only three times a week for 2 weeks. Primary outcome measures included the visual analog scale for pain, lumbar active range of motion assessments, and chair-rising times. Secondary outcome measures included a Multidimensional Fatigue Inventory, Fear-Avoidance Beliefs Questionnaire, and the Oswestry Disability Index. The outcome measures were assessed before therapy and 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months after the first interventions were completed.
Discussion: This study is a prospective, single-center, double-blind, randomized, controlled study. This study aims to research the efficacy of a 2-week LED program for NSCLBP working nurse. The results will be useful for patients, working nurses, nurses' aides, and other healthcare workers with chronic low back pain.
Trial registration number: This protocol was registered in ClinicalTrials.gov, under the number 108-088-F.
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
- Triple (Participant, 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
- 是
入选标准
- •male or female registered nurses aged 18-65 years with non-specific chronic LBP, which is defined as pain or discomfort between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs, and persistent LBP for at least 3 months
排除标准
- •severe skin diseases (e.g., skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis, and severe hives lupus)
- •LBP associated with nerve root compromise (measured by clinical examination of dermatomes, myotomes, and reflexes)
- •serious spinal pathologies, such as fractures, tumors, and inflammatory and infectious diseases
- •decompensated heart disease or metabolic disorders
- •previous spinal surgery
- •pregnancy.
结局指标
主要结局
measure assessing change of Chair-rising time between baseline to every time points
时间窗: 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
Chair-rising time, wherein the time required for participants to rise five times from a seated position in a standard chair to a standing position as quickly as possible, without using their arms for support, was measured. A longer chair-rising time represents greater physical function limitations.
measure assessing change of Lumbar active range of motion between baseline to every time points
时间窗: baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
Including forward flexion, extension, and right and left rotations and were measured in degrees using a back range of motion instrument.
measure assessing change of 100-mm visual analog scale (VAS) between baseline to every time points
时间窗: 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months
A 100-mm visual analog scale (VAS), which was used for low back pain assessment. The anchor terms of the VAS were 0 (no pain) and 10 (maximum pain imaginable). Higher VAS scores indicate greater pain intensity.
次要结局
未报告次要终点
研究者
Wei-Tso Chia MD PhD
Assistant Professor, Deputy Director of Orthopaedics Department
National Taiwan University Hospital Hsin-Chu Branch