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临床试验/NCT05391568
NCT05391568已完成不适用

Effects of Dry Needling on Autonomic Nervous System and Nociceptive Pain Processing in Neck Pain. A Randomized Clinical Trial.

Universidad Complutense de Madrid2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月31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
60
试验地点
2
主要终点
Skin Conductance

研究概览

简要总结

Pain in the neck is a musculoskeletal disorder that affects many individuals. Dry needling has shown an effective technique for the treatment of shoulder and neck disorders. The mechanisms of action of the dry needling are not well-known. This study aims to evaluate the effects of dry needling in the upper trapezius on the autonomic nervous system and nociceptive pain processing in patients with non-specific neck pain.

Hypothesis: Dry needling applied in the upper trapezius in patients with non-specific neck pain produced greater activation of the autonomic nervous system and nociceptive pain processing than sham dry needling.

详细描述

A randomized, double-blind, placebo-controlled clinical trial, using Dry Needling (DN). DN is a technique to treat musculoskeletal pain and physical impairment that consists of introducing needling filaments in the muscle trigger points.

Study Aims:

Aim #1: The primary aim of the study is to compare the effect (during the technique and five minutes after intervention) of a single session of DN on autonomic nervous system as measured by skin conductance in patients with non-specific neck pain with random assignment to two treatments: DN or Sham DN

Aim #2: The secondary aim of the study is to compare the immediate effect on pain sensitivity as measured by pressure pain threshold, activation of descending inhibition pain pathways as measured by temporal summation and conditioned pain modulation in patients with non-specific neck pain with random assignment to two treatments: DN and Sham DN.

Aim #3: The secondary aim of the study is to compare the immediate effect on intensity of pain as numeric pain rating scale (NPRS), relating pain disability (Northwick Park Neck Pain Questionnaire), fear-avoidance of movement (Tampa Scale for Kinesiophobia) and Catastrophizing (Pain Catastrophizing Scale)

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Pain in the neck area, including the upper trapezius muscle;
  • At least one active TrP (i.e., TrP which referred pain is able to reproduce the patient symptoms in the upper trapezius)
  • Ability to read and understand Spanish
  • Self-reported Intensity of pain rating on the 0-10 NPRS for the neck-shoulder region is 3 or greater
  • Ability to understand, write, and speak Spanish fluently

排除标准

  • Neurological symptoms or signs compatible with cervical radiculopathy or myelopathy
  • Cervical trauma
  • Systemic diseases
  • Psychiatric problems
  • Fear of needles.

结局指标

主要结局

Skin Conductance

时间窗: Through study completion, an average of 20 minutes

Measured in the hand of the needled upper trapezius. Measured in microsiemens.

次要结局

  • Pressure Pain Sensitivity(Baseline; Immediate (10 minutes after intervention))
  • Conditioned Pain Modulation (CPM)(Baseline; Immediate (10 minutes after intervention))
  • Pain Intensity (Numeric Pain Rating Scale)(Baseline; one week after intervention)
  • Temporal Summation during conditioned stimuli.(Baseline; Immediate (10 minutes after intervention))
  • Kinesiophobia(Baseline; one week after intervention)
  • Pain Catastrophizing(Baseline; one week after intervention)
  • Pain Intensity during Intervention (Numeric Pain Rating Scale)(Baseline; immediate (ten minutes after intervention))
  • Pressure Pain Stimuli for Temporal Summation(Baseline; Immediate (10 minutes after intervention))
  • Neck Pain-related Disability(Baseline; one week after intervention)
  • Temporal Summation(Baseline; Immediate (10 minutes after intervention))
  • Global Rating of Change Scale (GRoC)(One week after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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