Visceral Manipulation in Patients With Chronic Low Back Pain: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Low Back Pain After 6 Weeks of Intervention
研究概览
简要总结
Non-specific chronic low back pain is a common multifactorial condition common to the world population. It is defined as a pain and discomfort located below the ribs and above the gluteal folds that may or may not have referred pain in the leg for more than 12 weeks. Visceral manipulation is a manual therapy technique that aims to normalize mechanical, vascular and neurological dysfunctions of the viscera with the objective of improving its functioning. Visceral dysfunction may potentially activate or exacerbate the symptoms of low back pain in the presence of compromised movements between the internal organs and its connective tissues. There are two ways in which a change in visceral mobility could interfere with low back pain, referred visceral pain and central hypersensitivity. The first occurs due to neural convergence, since there is no spinocortical tract that only sends visceral or somatic afferences, its afferences are crossed in the dorsal horn of the spinal cord. The second is that the prolonged and continuous activation of nociceptors, due to the alteration in the mobility of the gastrointestinal and urinary system, can generate central hypersensitivity. Therefore, the investigators hypothesized that through the visceral manipulation the fascial adherences would lyse and the visceral spasms would demise, reducing the peripheral input, thus, lessening pain in the low back.
详细描述
Ethical aspects: All volunteers will be informed about the experimental procedures that will be submitted, as well as the fact that these do not affect the participant's health. The participants will also be clarified as to the secrecy of the information collected during the study performance, protecting the identities of the participants. After agreeing to participate in the research, each volunteer will sign the Informed Consent Term, according to resolution 196/96 and update in resolution 466 in 2012 of the National Health Council.
Risks:The interventions offer no harm to the participant's health. There is the possibility of the participant feeling pain and / or tickling during abdominal palpation. If these sensations occur, the procedure will be stopped and tried again. If sensations persist and the participant can not support them the session will be rescheduled or the participant will be disconnected from the study as there is no other way to carry out the proposed therapy.
Benefits:There may be no direct or immediate benefits, however, it is expected that the proposed treatment will improve lumbar pain.
This study does not offer any type of health insurance, and also, it is the responsibility of the participant to get around and bear the costs of transportation to the place of collection of data.
Confidentiality and privacy of research participants will be guaranteed during all phases of the research. At any time the participant can withdraw consent to participate in the research without any kind of penalty.
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 (Outcomes Assessor)
盲法说明
The evaluator will be blind as he will not be present during the intervention. As well as the care provider will not be present during the assessor activities.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary complaint of chronic non-specific low back pain (more than 12 weeks);
- •pain symptoms in the low back with a score ≥ 2/10 on the 0-10 Numerical Pain Rating Scale (12);
- •aged 18-80;
- •history of surgery in the abdominopelvic region for more than 6 months;
- •history of visceral dysfunction (e.g., constipation and reflux); and
- •no known or suspected serious spinal pathology (e.g., metastasis, inflammatory or infective diseases of the spine, causa equine syndrome, canal stenosis, spinal fracture).
排除标准
- •no nerve root compromise evidenced by at least two of the following: (1) myotomal weakness, (2) dermatomal or widespread sensory loss, (3) hyporeflexia or hyperreflexia of the lower limb reflexes;
- •no spinal surgery within the preceding 6 months;
- •no vascular abnormality such as abdominal aortic aneurysms;
- •not currently receiving chiropractic, osteopathic or other physical therapy;
- •not pregnant or suspect being pregnant;
- •not currently in an acute inflammatory phase of known gastrointestinal or urinary diseases (such as cholecystitis, renal calculi, peritonitis, appendicitis);
- •not currently taking medications that significantly alter gut motility;
- •not currently taking medications (such as oral corticosteroids) which are known to increase the risk of intestinal perforation);
- •no known gastrointestinal disease that associates with a risk of intestinal perforation (e.g. Chron's disease, diverticular disease, peptic ulcer disease);
- •not taking anti-platelet medications such as warfarin.
结局指标
主要结局
Low Back Pain After 6 Weeks of Intervention
时间窗: 6 weeks
An 11-point Numeric Pain Rating Scale (NPRS) will be used, where 0 is equivalent to "no pain" and 10 to "unbearable pain"
次要结局
- Functional Activity After 6 Weeks of Intervention(6 weeks)
- Low Back Mobility Using the Schober Test After 6 Weeks of Intervention(6 weeks)
- Disability Due to Low Back Pain After 6 Weeks of Intervention(6 weeks)
研究者
Luciane Cruz Lopes
Director, Clinical Research
University of Sorocaba