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临床试验/NCT01984021
NCT01984021已完成1 期

Evaluation of the Immediate Effect of Acupuncture on Pain, Cervical Range of Motion and Electromyographic Activity of the Upper Trapezius Muscle in Patients With Nonspecific Neck Pain: Randomized, Single-blinded, Sham-controlled Study.

University of Nove de Julho1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
24
试验地点
1
主要终点
electromyographic activity

研究概览

简要总结

The aim of the proposed study is to evaluate the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain.Twelve patients with nonspecific neck pain and 12 healthy subjects will be enrolled in a randomized, single-blind, crossover study. Each patient will receive two forms of treatment in random order: a single session of traditional acupuncture and sham acupuncture. To eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine motor control in the upper trapezius muscle before and after treatment. The outcome measures in the group with neck pain will be a numerical pain rating scale (range: 0 [no pain] to 10 [maximum pain]), documentation of the pain area on a body chart and cervical range of motion. Linear regression analysis will be applied for each individual to investigate associations between the sEMG variables and force (excluding the sixth step). The slopes of the regression lines will be used to measure the sensitivity of the sEMG variables regarding changes in force. The Shapiro-Wilk test will be used to test the normality of the data distribution regarding RMS and MDF values in the third and sixth step of the step contraction. Paired samples (Student's t-test or Wilcoxon test) will be used to test differences between third and sixth contraction step. A mixed linear model will be used to analyze and compare the sEMG data during sustained contraction (five steps) between pre-acupuncture (EMG-1) and post-acupuncture (EMG-2) evaluations. These comparisons will demonstrate whether acupoints TE-5 and LI-11 affect the activity of the upper trapezius muscle, as hypothesized. The pain (NRS, PPT and area) and cervical ROM data collected during the four evaluations will also be compared using a mixed linear model. The Statistical Package for Social Sciences (SPSS, version 19.0 for Windows) will be employed for the statistical analysis, with the level of significance set to 5% (p < 0.05).

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 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18 to 40 years
  • •male and female volunteers

排除标准

  • •history of neurological disorders
  • •neck surgery
  • •chronic neck pain resulting from a traumatic incident
  • •chronic musculoskeletal condition
  • •medical diagnosis of fibromyalgia; systemic disease
  • •connective tissue disorder
  • •non-tolerance of needles; current pregnancy
  • •having undergone physical therapy use of analgesic, muscle relaxant.

研究组 & 干预措施

traditional acupuncture (tACP)

Experimental

In the upper trapezius muscle with the greatest area pain and lowest PPT score will be chosen for acupuncture. Sterile acupuncture needles measuring 0.25 x 13 mm (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd.®) will be inserted in TE-5 (located on the dorsal face of the forearm between the radius and ulna 3 cm above the joint line of the wrist) and LI-11 (located at the outermost point of the skinfold of elbow flexion in the direction of the lateral epicondyle of the elbow).

干预措施: Acupuncture (Device)

sham acupuncture (sACP)

Placebo Comparator

The needles will be inserted 1 cm to the side of TE-5 (located on the dorsal face of the forearm between the radius and ulna 3 cm above the joint line of the wrist) and 1 cm to the side of LI-11 (in the direction of the styloid process of the radius).The acupuncture needles are positioned at different acupoints.

干预措施: Sham acupuncture (Device)

结局指标

主要结局

electromyographic activity

时间窗: 1 Year

The EMG signal will be recorded in the dominant upper trapezius muscle in patients with nonspecific neck pain, will be evaluated before and after treatment.

次要结局

  • cervical range of motion(1 Year)

研究者

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

Cid André Fidelis de Paula Gomes

MSc

University of Nove de Julho

研究点 (1)

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