Efficacy of High-intensity Laser Acupuncture in Patients With Chronic Non-specific Low Back Pain: a Double-blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- peak torque
研究概览
简要总结
The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture on peak torque, power of trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic nonspecific low back pain (CNLBP).
详细描述
Chronic nonspecific low back pain (CNLBP) is a persistent back pain that affects people of all ages and contributes to the global disease burden. Treatment focuses on reducing pain and its consequences. High-intensity laser therapy is a non-invasive, painless modality that can be easily administered for various conditions. It has been proven to significantly reduce pain, with anti-inflammatory, anti-edematous, and analgesic effects. Laser photobiomodulation (PBM) therapy is a non-invasive and painless method that stimulates cells, pain receptors, and the immune system and can cause vasodilation and analgesic effects. Acupuncture is a common complementary therapy that has been proven to treat musculoskeletal pain and enhance muscle strength, and high-intensity laser acupuncture (HILA) has been promoted as an alternative to traditional needle acupuncture. HILA, as a non-invasive treatment, combines the efficacy of high-intensity laser and acupuncture in musculoskeletal pain management. Due to a lack of research, this study will examine the effects of HILA on peak torque and power of the trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic non-specific low back pain.
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
- Double (Participant, Outcomes Assessor)
盲法说明
random generator
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients had CNSLBP with age from 20 to 40 years from both genders.
- •Patients will be referred from an orthopedist with diagnosis of chronic low back pain without underlying pathological causes.
- •The patients with chronic nonspecific low back pain more than 3months. Minimum pain intensity of 30 mm on the visual analogue scale (VAS) for pain, which ranges from 0 to 100 mm.
- •Patients with normal BMI ranges between 18.5:24.9 kg/m
- •The study populations must be willing to participate in the study
排除标准
- •Neurological, infectious diseases and systemic illness such as rheumatologic diseases,systemic lupus erythematosus, diabetes mellitus type I or II.
- •Psychiatric/mental deficit.
- •Patients who had a previous surgical history (within 6 months) will also excluded.
- •participation in other treatment within the previous 3 month.
- •History of spinal fracture, tumor, osteoporosis
- •use of medication, such as corticosteroids, anticonvulsants, and anti-inflammatory drugs that may affect the outcome of the study.
- •prior history of adverse effects to physical stimulation therapy.
- •significant physical or mental deficiencies preventing a clear understanding of the study procedure.
- •spinal stenosis, thyroid dysfunctions, obesity, pace-maker.
研究组 & 干预措施
high-intensity laser acupuncture and an exercise therapy program.
The patients will receive high-intensity laser acupuncture and an exercise therapy program.three times a week for four weeks.
干预措施: high-intensity laser acupuncture and Exercise therapy program (Device)
sham laser acupuncture and an exercise therapy program.
The patients will receive a sham acupuncture laser and an exercise therapy program three times a week for four weeks.
干预措施: Sham laser acupuncture (Other)
结局指标
主要结局
peak torque
时间窗: follow up after 1 month
Isokinetic dynamometer will be used for measuring peak torque of back extensors and flexors..
Average Power
时间窗: follow up after 1 month
Isokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.
peak torque
时间窗: up to four weeks
Isokinetic dynamometer will be used for measuring peak torque of back extensors and flexors.
Average Power
时间窗: up to four weeks
Isokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.
次要结局
- lumbar flexion and extension ROM assessment(follow up after 1 month)
- Disability(follow up after 1 month)
- Pain Intensity(follow up after 1 month)
- patient Satisfaction(follow up after 1 month)
- lumbar flexion and extension ROM assessment(up to four weeks)
- Pain Intensity(up to four weeks)
- Disability(up to four weeks)
- patient Satisfaction(up to four weeks)
研究者
Doaa Ayoub Elimy Mohammed
Lecturer of physical therapy for basic science department., faculty of physical Therapy
Cairo University