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临床试验/NCT03979287
NCT03979287已完成不适用

Efficacy of a Interferential Current and Therapeutic Exercise Program in Subjects With Chronic Neck Pain

University of Seville1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年7月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Disability

研究概览

简要总结

Objectives: To analyze the number of sessions needed to achieve a positive impact after combining interferential current therapy and therapeutic exercise, compared with therapeutic exercise alone, on self-reported pain, disability and range of motion in subjects with chronic neck pain.

Design: A randomized, single-blind, controlled trial. Subjects: Patients between 18 and 65 years old, with idiopathic chronic neck pain.

Methods: The experimental group who will perform a combined treatment using Interferential current therapy and therapeutic exercise for two weeks. The control group will receive the same program of therapeutic exercise during the same period of time.

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 (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
否

入选标准

  • •Nonspecific mechanical neck pain (chronic neck pain diagnosed by a physician)
  • •Age between 18 and 65 years old
  • •Both males and females
  • •Non apprehension to electrotherapy (determined by the Personal Psychological Apprehension scale- EAPP)
  • •Self-reported pain higher than 2 in the 11-point Numeric Pain Rating Scale

排除标准

  • •Metallic implants in the vertebral column
  • •Apprehension to electrotherapy (a score >45 points in EAPP)
  • •Cervicogenic headache
  • •Cervicogenic Dizziness
  • •Neck pain associated with neurological deficits
  • •Unexplained fever
  • •Cervical surgery associated to persistent pain
  • •Specific diagnostics (cervical myelopathy, cervical stenosis, osteomyopathy)
  • •Other diagnostics such as visceral pain referred to the neck or non-cervical cause.
  • •Involvement in litigation
  • •Manual treatment for the neck-shoulder area in the last month before data collection

研究组 & 干预措施

IFC and Therapeutic Exercise Program

Experimental

Patients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour. Participants will receive treatment with Interferential current therapy plus a program of therapeutic exercise focused on the neck region

干预措施: Interferential Current and Therapeutic Exercise Program (Other)

Therapeutic Exercise Program

Active Comparator

Patients will receive 10 sessions for two weeks. The duration of each session will be of approximately one hour.This group will only receive the same therapeutic exercise program.

干预措施: Therapeutic Exercise Program (Other)

结局指标

主要结局

Disability

时间窗: From baseline to immediately after treatment

The Neck Disability Index (NDI) will be used in the Spanish version to measure level of disability of the neck area during the daily life activities. where under 9 denotes No Disability; from 10 to 29 denotes Slight Disability; from 30 to 49 denotes Moderate Disability; from 50 to 69 denotes Severe Disability and more tan 70 denote Complete Disability.

Neck pain intensity

时间窗: From baseline to immediately after treatment

Participants will rate the intensity of their neck pain at rest on an 11-point numeric pain rating scale, where 0 is no pain and 11 maximum pain. The subjects will be ask to indicate the pain levels that they experienced before treatment and after treatment.

次要结局

  • Range of movement (ROM)(From baseline to immediately after treatment)

研究者

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

Alberto Marcos Heredia-Rizo

Assistant Professor

University of Seville

研究点 (1)

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