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临床试验/NCT03610204
NCT03610204已完成不适用

The Effect of Pressure Intensity of a Chinese Massage With the "Buffalo Horn Technique" on Pain Relief for Mechanical Low Back Pain.

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年8月3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
56
试验地点
1
主要终点
Visual analogue scale (VAS) for pain severity

研究概览

简要总结

The Investigators conduct this study to compare two different massage methods with "buffalo horn technique": the deep massage and the superficial massage. To explore the effects of the two interventions on low back pain, the investigators evaluated the outcome measurements regarding pain severity and physical functions before and after 6 times of treatment through a 3-week period.

详细描述

Background: Nonspecific lower back pain is an important global health issue, with high prevalence over the world and causing huge economic loss.

This research is a double-blind randomized controlled trial. In this study the investigators introduce a technique derived from traditional Chinese massage using a special tool made from buffalo's horns to perform the massage, so called "buffalo horn technique". The tool is like a short rod in about 15-cm length with a cone-like end. During the massage, the therapist presses the cone-like end against the painful region of back. Because the cone-like end has a small contact area with the participant's body surface, it may release deep layer fascia with higher pressure produced by the therapist toward the treatment area. During the intervention of shallow massage, the therapist applies a lower force then that used in the deep massage. Thus it produces a lower pressure on the painful region due to a larger contact surface when pressing the rod end against the body of the participant.

Participants are randomly assigned to either deep-massage group (DM) or superficial-massage (SM) group. The participants received two sessions a week for a total six sessions. The outcome measures include the structured questionnaire to investigate the pain-related outcomes and back pain-related disabilities. The investigators also perform the clinical assessments such as range of motion of trunk. All the outcomes are assessed before-intervention (pretest) and after the end of intervention (posttest).

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

Since the patient are prone during the low back massage, the patient will not know what treatment they receive, as the two treatments are similar and only different in the pressure force.

The primary outcome is assessed by a self-reported questionnaire. The assessor who performs the clinical assessments will be blinded to the treatment assignment.

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Non-specific low back pain over 1 months
  • 20-65 years old
  • No experience of massage therapy within 2 months prior to the study inclusion.

排除标准

  • Back pain associated with systemic disease (autoimmune, infectious, vascular, endocrine, metabolic, or neoplastic disease)
  • Previous spine surgery.
  • Presentation with neurological signs such as radiating pain.
  • .Skin diseases (psoriasis, urticaria, wounds, etc.)

结局指标

主要结局

Visual analogue scale (VAS) for pain severity

时间窗: 7 weeks

0-100mm VAS where 0 represents no pain and 100 represents the strongest pain

次要结局

  • Roland-Morris Low Back Pain Disability Questionnaire(7 weeks)
  • Range of motion (ROM) of the trunk(3 weeks)
  • Oswestry Disability Index(7 weeks)
  • Short form of "World Health Organization Quality of Life Instrument" (WHOQOL-BREF)(7 weeks)
  • Pain pressure threshold(3 weeks)

研究者

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

Yen-Nung Lin

Director of Physical Medicine and Rehabilitation

Taipei Medical University WanFang Hospital

研究点 (1)

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