Effect of a Standard Treatment for Non-specific Low Back Pain Combined With Multimodal Osteopathy Treatment on Pain Intensity and Functional Capacity: A Randomized, Controlled, Blinded Trial"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
Background: Low back pain is one of the most common musculoskeletal health problem with the highest prevalence in the adult population; globally, it represents a relevant cause of medical, social and economic burden. The aim of the proposed study is to determine the effect of a standard treatment for non-specific low back (CNSLBP) combined with multimodal osteopathy treatment on pain intensity and functional capacity.
Methods: This will be a blind randomized clinical trial, with 44 patients with CNSLBP, randomly assigned into two groups: Experimental group (EG) treated with therapeutic exercises and multimodal osteopathy treatment (n=22) and Control group (CG) treated with therapeutic exercises (n=22). Participants will receive treatment twice a week (total of 16 sessions). The primary outcome is pain, measured by numeric rating scale (NRS: score 0-11 points). Secondary outcomes are: Patient-specific functional scale (scored from 0 to 30), Oswestry Disability Questionnaire (ODQ), finger-to-floor distance test (FFD). Participants will be evaluated pre- and post-treatment and after 1 and 3 months (follow-up).
Results: Analysis will be by intention to treat using linear mixed models. Comparisons between groups before and after treatment will demonstrate whether osteopathy treatment exerts a supplementary effect on pain and functional capacity in patients with CNSLBP. The data will be published after the study is completed. The study will support the practice of evidence-based physical therapy for individuals with CNSLBP.
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)
盲法说明
Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals within the age range of 18-70 years;
- •Chronic low back pain in the region between the 12th rib and the gluteal fold, with a minimum duration of 6 weeks with or without referral of pain in the lower limbs;
- •no specific cause detectable, such as infection, neoplasia, metastasis, osteoporosis, rheumatoid arthritis, fracture, inflammatory process or radicular syndrome.
- •baseline pain: minimum intensity score of 3 out of 10 (0 = no pain, 10 = most intense pain) considered and verified by the Numerical Pain Rating Scale (NPRS).
排除标准
- •Previous history of spinal disorders (local trauma, cauda equina syndrome, spinal canal stenosis, congenital abnormalities tumor);
- •Inflammatory or infectious diseases (rheumatoid arthritis, fibromyalgia and vertebral osteomyelitis);
- •Previous lumbar spine surgery;
- •Pregnant women;
- •Regular opioid analgesics (≥2 times per week) or opioid patches;
- •Receiving disability benefits for back pain or even for another health reason;
- •Previous injections for back pain, such as facet joint blocks, nerve root or epidural steroid injection in the previous year;
- •Having undergone physical therapy, massage, acupuncture or any other therapeutic intervention for back pain in the previous two weeks;
- •Osteopathy techniques that are not used as a treatment for low back pain;
- •Neuropathic pain tested with Laségue and Valsalva clinical tests.
结局指标
主要结局
Pain intensity
时间窗: Baseline and one week and 3 months (follow-up).
Changes in pain intensity, will be assessed using the NPRS (Numerical Pain Rating Scale). This is an 11-point scale where 0 means "no pain" and 10 means "worst possible pain". NPRS outcome measures will be evaluated pre- and post-treatment.
次要结局
- Lumbar mobility(Baseline and one week)
- Disability caused by low back pain(Baseline and one week)
- Patient-Specific Functional Scale(Baseline and one week)
- Prognostic Risk Assessment(Baseline and one week)
研究者
Fabiano Politti
Prof. Fabiano Politti, FT
University of Nove de Julho