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临床试验/NCT04423445
NCT04423445已完成不适用

Laser Acupuncture Combined With Acupressure Improves Low Back Pain and Quality of Life: a Randomized Controlled Trial

En Chu Kong Hospital2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2019年1月15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
76
试验地点
2
主要终点
pain intensity and interference

研究概览

简要总结

Background: Low back pain (LBP) is a common, huge health and socioeconomic health problem that affects physiological functions and reduces work efficiency in nurses.

Objective: This study aimed to evaluate the effect of low-level laser acupuncture combined with acupressure (LAA) on pain intensity, pain interference and life dysfunction in hospital nurses with LBP.

Methods: This single-blinded randomized controlled trial enrolled a convenience sample of nurses from one teaching hospital. Seventy-six participants were randomly assigned to the LAA group (n=38) receiving low-level laser acupuncture and auricular acupressure for four weeks, and a control group (n=38) receiving a similar intervention but without laser energy and acupressure. Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) and Roland-Morris Disability Questionnaire (RDQ) at three time points: baseline before the intervention, and Week 2 and Week 4 during the intervention.

详细描述

The enrollment criteria were age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3, no regular treatment for low back pain within six weeks, and willing to participate in this study. Exclusion criteria were open wounds on lower back, tumor on the back, ankylosing spondylitis, previous lumbar surgery, coagulopathy or bleeding tendency, or pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

This single-blinded randomized controlled trial

入排标准

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

入选标准

  • age more than 20 years, low back pain with visual analogue scale (LBP_VAS) ≧3
  • no regular treatment for low back pain within six weeks
  • willing to participate in this study

排除标准

  • open wounds on lower back
  • tumor on the back
  • ankylosing spondylitis
  • previous lumbar surgery
  • coagulopathy or bleeding tendency
  • pregnancy

结局指标

主要结局

pain intensity and interference

时间窗: Data were collected using the Short Form of the Brief Pain Inventory (BPI-SF) : baseline before the intervention, and the change from pain intensity and interference at 1 month.

Primary pain outcomes were measured by the Chinese version of the Brief Pain Inventory-Short Form (BPI-SF), which consists of 11 items to measure pain intensity and interference with functionality. Regarding pain severity, 4 items allow patients to rate their pain experience in the past 24 hours or one week at its average, worst, and least levels, as well as their pain experience now, on an 11-point Likert-type scale (0 = no pain, 10 = most severe pain).

次要结局

  • life dysfunction(Data were collected using the Roland-Morris Disability Questionnaire (RDQ) : baseline before the intervention, and the change from life dysfunction at 1 month.)

研究者

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

Hsueh-Hua Yang

Principal Investigator

En Chu Kong Hospital

研究点 (2)

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