Translational Study of the Effects of Neural Mobilization in Patients With Lomboisquiatalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain: Visual Analog Scale
研究概览
简要总结
The spinal nerve injury in humans often results in neuropathic pain characterized by spontaneous burning pain accompanied by allodynia and hyperalgesia. In this sense, lomboisquiatalgia is a neuropathy that is characterized by narrowing the intervertebral foramen of the lumbar vertebrae, leading a lumbar chronic pain which irradiate to a lower limb, being a clinical condition of difficult treatment. Neural Mobilization is a noninvasive technique used by physiotherapists. The technique aims to restore mobility and elasticity of the peripheral nervous system by tenses which are imposed on the roots, nerves, spinal cord and their respective meninges. This technique has been standardized in basic research and has shown promising results. However, clinically, this technique lacks randomized, controlled and double blind studies. Therefore, the investigators have to evaluate the effects of Neural Mobilization technique in patients with lomboisquiatalgia. In this study the investigators will treat patients three times a week, with ten minute treatment time per session, with 25 oscillations per minute for ten sessions. Many tools will be used to assess the effects of the protocol applied, for example: evaluation sheet, visual analogue scale (VAS), quality of life assessment - WHOQOL-bref questionnaire of Roland Morris disability, oswestry index on disability (version 2.0), enzyme-linked immunosorbent assays for the measurement of cytokines in the blood tissue. In this way, the investigators can contribute and understand the mechanisms involved in the rehabilitation process.
详细描述
Translational study of the effects of Neural Mobilization in patients with lomboisquiatalgia
The spinal nerve injury in humans often results in neuropathic pain characterized by spontaneous burning pain accompanied by allodynia and hyperalgesia [1]. These signs and symptoms occur in the continuous presence of ectopic focus of the afferent peripheral nervous system (peripheral sensitization) to the central nervous system (CNS) (central sensitization). After the traumatic experience both peripheral sensitization and central sensitization contributes to the appearance of poorly adaptive responses in the spinal cord as well as in the brain, contributing to chronicity and maintenance of neuropathic pain [2, 3]. The pain-induced neuropathy is currently being associated with the involvement of glial cells located in the spinal cord [4, 5]. Glial cells synthesize several substances, many of which are also released by nociceptive neurons that modulate the pain response, among which we can mention prostaglandins, glutamate, arachidonic acid, nitric oxide and cytokines pro inflammatory [6-9]. Pro-inflammatory cytokines appear to be involved in hyperalgesia and mechanical allodynia arising from nerve injury due to compression. Many studies have demonstrated that in models of peripheral nerve trunks ischemia, in rats, occurs an increase in pro-inflammatory cytokines that may be related to myelin damage and edema [10, 11]. Furthermore, studies using nerve compression model, increased identified interleukins (IL-6 or TNF) in rats with allodynia [12]. In this sense, the interleukins (IL) are proteins produced by T groups and many of these cells are involved in IL activation of lymphocytes, each of which has its effect on IL specific groups of cells expressing specific receptors which are identified by numbers: IL-1, IL4, IL-6, IL-10 [13]. Kraychete et. al. (2009), analyzed by means of blood samples the levels of pro-inflammatory cytokines in the plasma of patients with and without neuropathic pain, and found that patients with neuropathies had higher levels of these cytokines [14]. Kukkar et. al. (2012), a model of neuropathic pain (CCI) observed an increase of TNF-α level in the sciatic nerve after treatment with aliskiren (an anti-hipertensive drug) and a decrease in TNF-α with consequent improvement in nociception [15].
In clinical practice, has been extensively reported that neuropathic pain is difficult to treat due to inadequate understanding of the cellular and molecular mechanisms involved in the development and maintenance of this kind of pain [16, 17]. The therapeutic options for the control of neuropathic pain have increased in recent years [18]. However, responses to treatments is still not satisfactory. The neurosurgical treatments include pharmacological treatments, such as antidepressants, anticonvulsants, gabapentin, carbamazepine, systemic administration of local anesthetics, topical agents, narcotic analgesics and non-narcotic antiarrhythmics [17, 18]. Still, as a complementary non-invasive and non-pharmacological treatment, we find in the literature, the use of therapeutic resources for rehabilitation, depending on the kinf of injury. In this context, Neural Mobilization techniques have shown excellent prognosis in patients with differents kind of pain, besides other advantages, such as low operating cost, easy to use and no adverse effects [19]. Neural Mobilization is a noninvasive technique used by physiotherapists, this technique aims is, to restore mobility and elasticity of the peripheral nervous system by strains imposed on nerve trunks, roots, nerves, spinal cord and their wraps, the meninges due to the imposition of movements and joint angles [20].
Currently, the technique has been used as a method of evaluation and treatment of several diseases that affect the central nervous system (such as Stroke) or peripheral (herniated discs or nerve impingement) and structures such as, the muscles due to the existing integration between the musculoskeletal system and the nervous system [19, 21-23]. The healthy relationship, away from injuries, between peripheral nerves and locomotor system with respect to their tissue interfaces allows individuals to move from free and without pain [24]. Research by Dworkin et al., (2007) points out that the Neural mobilization is effective in conditions of musculoskeletal injuries to functional and pathological diagnosis [21]. However, the authors mention that for each musculoskeletal condition a kind of neural mobilization should be performed. Also depending on the clinical condition of the patient other therapies may be included in treatment plan. Our group has been studying last six years, and standardizing the technique Neural Mobilization (MOB) in rats. Encouraging results were found using our treatment protocol. We demonstrated that the MOB reduced nociceptive frame, through the involvement of opioid receptors in the central nervous system (PAG) and peripheral (DRG), involvement of substance P, TRPV 1, NGF, PO (protein zero), intense regeneration process in sciatic nerve and, exponential increase in muscle strength [25-28,34]. Thus, we believe that Neural Mobilization technique, through basic research, appears to be effective in the antinociceptive process.
EXPECTED RESULTS:
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Selected will be subject to meeting the following criteria: chronic low back pain radiating to the leg for more than three months from the narrowing of the intervertebral foramen of the lumbar vertebrae (lomboisquiatalgia), ie for more than 12 weeks; age ≥ 20 years; score ≥ 4 on analog pain scale (VAS); DN4 ≥ 4 on scale; both genders; positive for the following special tests: Slump-Test, the straight leg raising test, Lasègue Test, Rise Of Opposite Leg and Sign of Arc or Bowstring-Sign rope; score ≥ 4 on the Roland Morris Disability Questionnaire (RMDQ); ≥ moderate dysfunction in Oswestry Low Back Pain Disability Questionnaire.
排除标准
- •Will be excluded from study subjects with the presence aged over 35 years, acute lumbar pain; recent history of violent trauma; spondylolisthesis or fibromyalgia; previous surgery column, any sequel that causes limitation in the lower limb range of motion (joint deformity), subjects suffering precaution for Neural Mobilization or cortical stimulation transmagnética as pacemaker, metal plates, screws, neurological disorders; systemic disease, immunosuppression, cancer patients, psychological disorders, cognitive disorders and failure, any kind of pain in other regions is not characteristic of lomboisquiatalgia and lack of cooperation or cognitive capacity to perform clinical procedures and pregnant women. The subjects will be kept blind to the treatment allocation. Researchers involved in the application of techniques will be kept blind throughout the development and analysis of the study.
结局指标
主要结局
Pain: Visual Analog Scale
时间窗: 1 month
VAS - Visual Analog Scale
次要结局
- Quality of life: Questionnaire WHOQOL-bref(1 month)
研究者
marucia chacur
PHD
University of Sao Paulo
