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临床试验/NCT02906540
NCT02906540已完成不适用

Transpubic Symphysis Reset for Treatment of Low Back Pain: a Stratified, Randomized, Controlled Clinical Trial

Shengjing Hospital0 个研究点目标入组 100 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
Visual Analog Scale pain scores

研究概览

简要总结

To verify the efficacy of transpubic symphysis reset therapy for low back pain, and provide support for the clinical application of this treatment.

详细描述

Low back pain is a common clinical affliction involving the back muscles, nerves, and bones. This condition mainly manifests as limited lumbar mobility, decreased back muscle strength and endurance, and disordered as well as asymmetrical movement of lower back muscles. Although these symptoms can severely impact quality of life and work, most patients report no precise origin of the condition. Low back pain may be associated with mechanical musculoskeletal damage, inflammation, cancer, and infection. More than 80% of adults experience low back pain at some point during their lifespan, although most patients are between 40-80 years old. As many countries have an aging population, the incidence of low back pain is increasing globally. Most patients suffer recurrent low back pain, which becomes more and more serious with each manifestation.

Patients with nonspecific low back pain often choose conservative treatments, such as physiotherapy. Compared with surgery and drug therapy, physiotherapy is advantageous as a treatment associated with low trauma, high comfort, few side effects, and low cost. Previous studies have confirmed that treatment with ultrashort waves can improve blood and lymph circulation in diseased areas and enhance the phagocytosis of macrophages and leukocytes, as well as having an anti-inflammatory effect, making it effective in the treatment of low back pain. Additionally, thermotherapy can directly expand the microvascular network of external annulus fibrosus, increase vascular permeability, promote venous return of partial metabolic waste, increase analgesic substance endorphin levels in vivo, suppress the generation of pathological excitatory foci in the brain, and accelerate the self-repair of injured cells, thus improving low back pain.

Chinese traditional massage is also a common clinical therapy. The application of pressure to the waist, hip, and lower limb on the affected side of the body can improve local blood circulation, promote the absorption of inflammatory exudates, reduce muscle tension, loosens abdominal adhesion, and mitigate muscle spasms to restore a normal anatomical position. Indeed, the efficacy of massage in the treatment of low back pain has been confirmed, according to five reports addressing manipulation for treating low back pain in Science Citation Index and four separate trials regarding such manipulation listed in ClinicalTrials.gov.

Transpubic symphysis reset is a massage therapy for treatment of low back pain. Although the efficacy of this treatment has been observed in the clinic, few studies have reported on the efficacy of transpubic symphysis reset in mitigating low back pain.

Data collection, management, analysis, and open access Data collection Two physicians, who will not participate in the experimental treatment or evaluation, will collect all patient data. The investigators will use the double data entry strategy. The data will be summarized and numbered by the research manager. A database will be established using Excel software. For questionable data, the data manager will present the data query table to the investigator for review and response. The researcher will answer the questions and return the table as soon as possible. The data manager will modify and check the data according to the researcher's answer. If necessary, the data manager can resubmit a question sheet.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No abnormalities of the lumbar spine and no intervertebral disc slipping or mild protrusion revealed via CT scans or MRI
  • Pain in the lumbosacral region
  • Pain in the unilateral lower back, including the buttocks, inguinal region, and perineal region
  • Patient is unable to sit for a long duration
  • Varying degrees of crooked hip and claudication
  • A history of chronic fatigue disease involving a lumbar sprain, a fall injury affecting the buttocks, or prolonged sitting
  • Tenderness of sacroiliac joint on the affected side
  • Course of disease between 1 day and 6 months
  • Age between 18 and 75 years old, any gender
  • Provision of informed consent regarding the trial procedure

排除标准

  • Sciatic nerve radiating pain caused by lumbar disc herniation
  • Lumbar spinal stenosis combined with intermittent claudication
  • Edema and necrosis produced by lumbar spinal cord compression revealed by MRI
  • Clear spinal deformity
  • Low back pain induced by cancer and associated inflammation
  • Hip malformation and bone disease
  • Coagulopathy
  • Ongoing participation in physiotherapy and massage therapy

结局指标

主要结局

Visual Analog Scale pain scores

时间窗: 14 days after treatment

To use the Visual Analog Scale for pain to evaluate the severity of low back pain. The scale consists of a 10-cm line with 0 on one end, representing no pain, and 10 on the other, representing the worst pain ever experienced. The patient indicates their level of pain by placing a mark somewhere on the scale, between 0 and 10

次要结局

  • Changes of Oswestry Disability Index(1, 7, and 14 days, and 1 month after treatment)
  • Changes of hip muscle strength(1 day before treatment, 1, 7, 14 days, and 1 month after treatment)
  • Changes of joint motion(1 day before treatment, 1, 7, 14 days, and 1 month after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hongliang Liu

Attending Physician

Shengjing Hospital

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