Efficacy of Mobilization With Movement on Conditioned Pain Modulation in Chronic Low Back Pain Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Conditioned pain modulation
研究概览
简要总结
Patients with chronic low back pain may have altered endogenous mechanisms, which can be evaluated with conditioned modulation paradigms. Mobilization with movement has demonstrated improvements in endogenous analgesic mechanisms in conditions such as knee osteoarthritis or lateral epicondylalgia. However, its effects have not yet been studied in patients with chronic low back pain. The objective of this randomized clinical trial is to evaluate the efficacy of mobilization with movement compared to placebo on endogenous mechanisms in patients with chronic low back pain.
详细描述
Low back pain is the leading cause of disability worldwide, and chronic low back pain (CLBP) has a prevalence of 2-25%, 80% of which are classified as non-specific low back pain because the causal factors have not yet been determined. Although different mechanisms can be attributed to the chronification of pain, a frequent denominator is the amplification of nociceptive transmission or decreased inhibition of nociceptive stimuli in the peripheral and/or central nervous system.
To assess inhibitory pathways, conditioned pain modulation (CPM) paradigms are commonly used in humans. They are based on the idea that a noxious stimulus applied to one part of the body can inhibit pain elsewhere by activating the descending inhibitory system.
When CPM is evaluated in patients with chronic low back pain, contradictory results are found, with studies reporting an alteration of pain modulation mechanisms and others not.
Different studies found that manual therapy can improve CPM compared to sham in patients with chronic musculoskeletal pain, such as lateral epicondylalgia or knee osteoarthritis. However, its effects in patients with chronic low back pain have not yet been studied.
Therefore, the aim of this study was to investigate the effect of mobilization with motion on CPM in patients with chronic musculoskeletal 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
Randomization was conducted by single randomization. Allocation of the selected patients to different groups (A, intervention; B, placebo) was implemented by opaque envelopes. The randomization was performed by personnel not involved in the trial, such as clinics receptionist. The personnel placed the random characters into sealed opaque envelopes and provided the group allocation to patients. The envelopes were opened only by the manual therapist, without letting the patient know to which group they were assigned to. Additionally, outcomes assessor was blinded to which group patients were assigned to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with chronic low back pain (>3 months of pain duration)
- •2 or more on a scale of 0 to 10.
排除标准
- •Radiculopathy
- •Neurological signs, symptoms, or deficit
- •Rheumatic or autoimmune disease
- •Cutaneous disease
- •History of fracture or spinal surgery
- •Pregnancy
- •Neuropathic pain
- •Active cancer
- •Spondylolysis/Spondylolisthesis
- •Mild/Severe cognitive impairment which interferes with outcomes measurement
结局指标
主要结局
Conditioned pain modulation
时间窗: 30 minutes
Conditioned pain modulation of low back, measured on interspace between L5 and S1. Pressure pain threshold (PPT) was used as test stimulus while ischemic pain (using cuff) was used as conditioning stimulus. CPM effect were calculated as the differences between the PPT values with and without the conditioning stimulus.
次要结局
- Body Chart(Baseline)
- Anxiety(Baseline)
- Depression(Baseline)
- Pressure pain threshold(30 minutes)
- Kinesiophobia(Baseline)
- Disability(Baseline)
- Quality of life (QoL)(Baseline)
研究者
Eleuterio Atanasio Sánchez Romero
PhD, Clinical Professor
Universidad Europea de Madrid