Effect of Acupuncture and Laser Acupuncture on Pain and Functional Capacity in People With Chronic Nonspecific Low Back Pain: a Randomised Controlled, Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 主要终点
- Pain intensity
研究概览
简要总结
The aim of this randomized clinical trial will be to compare the efficacy between acupuncture and laser acupuncture on pain and disability in people with chronic nonspecific low back pain .
详细描述
Forty-four patients with chronic cnLBP of more than three months duration will be randomly allocated to two groups: acupuncture group (ACP) (n = 22) and laser acupuncture group (LACP) (n = 22).Interventions will last one hour, and will happen twice a week for 5 weeks. The primary clinical outcomes will be pain intensity (11-point numeric pain rating scale) as measured and functional disability (Oswestry Disability Index).The secondary outcomes will be the Pain Catastrophizing Scale, Patient-Specific Functional Scale and fingertip-to-floor test. Evaluations will be performed before and after the first session, after 5 weeks of treatment, and three months after randomization (follow-up). The findings will be analyzed statistically considering a 5% significance level (p ≤ 0.05).
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
- 否
入选标准
- •Age 18-65 years;
- •Non-specific LBP for at least three months
- •Pain intensity of at least 2 points measured using the Numeric Pain Rating Scale
排除标准
- •Pregnancy;
- •Any contraindication to ACP or having undergone treatment in the previous six months
- •Having undergone spinal surgery in the previous six months;
- •Serious spinal pathology (e.g. metastasis, spinal fracture, inflammatory, and infective diseases, caudal equine syndrome, canal stenosis, osteoporosis, rheumatoid arthritis and lumbar radiculopathy);
- •Currently in an acute inflammatory phase of known gastrointestinal or urinary diseases (such as cholecysticis, renal calculi, peritonitis, appendicitis);
结局指标
主要结局
Pain intensity
时间窗: 3 months
The Numeric Pain Rating Scale will be used to determine the level of pain intensity perceived by the patient using an 11-point scale on which 0 represents the absence of pain and 10 represents the worst pain imaginable.
Functional disability
时间窗: 3 months
The Oswestry Disability Index will be used to determine the functional disability of participants. Questionnaire examines perceived level of disability in 10 everyday activities of daily living. The 6 statements are scored from 0 to 5 with the first statement scoring 0 through to the last at 5. Interpretation of Scores 1. 0% to 20% - minimal disability 2. 21%-40% - moderate disability 3. 41%-60%- severe disability 4. 61%-80%- crippled 5. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
次要结局
- Pain Catastrophizing(3 months)
- Mobility of spine and pelvis(3 months)
- Functional independence.(3 months)
研究者
Fabiano Politti
Principal Investigator
University of Nove de Julho