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临床试验/NCT01153737
NCT01153737已完成不适用

Primary Care Randomized Clinical Trial: Manual Therapy Effectiveness in Comparison With TENS in Patients With Neck Pain

Gerencia Atencion Primaria Area 32 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2005年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Pain intensity measured in millimeters (Visual Visual Analogue Scale, VAS)

研究概览

简要总结

This study investigated effectiveness of manual therapy (MT) with Electric Nerve Stimulation (TENS) to reduce pain intensity in patients with mechanical neck disorder (MND). A randomized multi-centered controlled clinical trial was performed in 12 Primary Care Physiotherapy Units in Madrid Region.

详细描述

The purpose of tis study is to evaluate the effectiveness of manual therapy (MT) with Electric Nerve Stimulation (TENS) to reduce pain intensity in patients with mechanical neck disorder (MND). Design: randomized multi-centered controlled clinical trial. Location: 12 Primary Care Physiotherapy Units in Madrid Region. Ninety patients were included with diagnoses of subacute or chronic MND without neurological damage, 47 patients received MT and 43 TENS. The primary outcome was pain intensity measured in millimeters using the Visual Analogue Scale. Also disability, quality of life, adverse effects and sociodemographic and prognosis variables were measured. Three evaluations were performed (before, when the procedure finished and six months after). Seventy one patients (79%) completed the follow-up measurement at six months. In more than half of the treated patients the procedure had a clinically relevant "short term" result after having ended the intervention, when either MT or TENS was used. The success rate decreased to one third of the patients 6 months after the intervention. No differences can be found in the reduction of pain, in the decrease of disability nor in the quality of life between both therapies. Both analyzed physiotherapy techniques produce a short term pain reduction that is clinically relevant.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • diagnoses of subacute or chronic MND without neurological damage, according to the Classification of the Quebec Task Force on Spinal Disorders (Spitzer 1987);
  • full physical and psychological capacity to follow the clinical trial's requirements;
  • consent to participate

排除标准

  • Signs of neurological damage according to the Neurologic Screening Checklist (Hoving et al. 2002),
  • pregnant women,
  • previous neck rachis surgery,
  • patients who received physical therapy or an alternative treatment of the neck or shoulder 6 months prior to the beginning of the study,
  • patients who intended to receive other treatments during the study
  • patients with important psychiatric disorders or other health problems that would contraindicate the techniques to be used (i.e. pacemaker).
  • Patients with neck pain caused by an inflammatory, neurological or rheumatic disease, severe osteoporosis, fracture, luxation or vertebrobasilar insufficiency

结局指标

主要结局

Pain intensity measured in millimeters (Visual Visual Analogue Scale, VAS)

次要结局

未报告次要终点

研究者

发起方
Gerencia Atencion Primaria Area 3
申办方类型
Other Gov

研究点 (2)

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