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临床试验/NCT00885859
NCT00885859Unknown不适用

Is Transcutaneous Electrical Nerve Stimulation (TENS) an Effective Method to Modulate Pain Transmission and Pain Perception in Patients Suffering From Chronic Non-Specific Pain Syndromes?

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
62
试验地点
1
主要终点
Contact heat evoked potentials (CHEPS)

研究概览

简要总结

  • Transcutaneous electrical nerve stimulation (TENS) is a frequently applied therapy in chronic pain. Although evidence regarding the effectiveness of TENS in chronic pain is inconclusive many patients continue using TENS on long term in daily practice. An important question is therefore why some patients respond well and others don't at all. In chronic pain evidence for abnormal pain processing (sensitization) has been found in several patients groups. The process of sensitization might influence effectiveness of TENS as the theoretical working mechanism of TENS is based on the modulation of the transmission of nociceptive impulses form peripheral receptors throughout spinal nerve system into the brain. In this study we want to study the effect of TENS on pain transmission, as measured by contact heat evoked potentials (CHEPS), between 'responders' and non-responders' after a two weeks TENS treatment. 'Responders' will be defined as patients with a pain reduction of ≥ 30% on a VAS after a two week treatment period with TENS. Non-responders are patients with a pain reduction < 15%.
  • Objective: a) Is pain reducing effect TENS in responders based on modulation of pain transmission and perception, as measured by CHEPS? b) Is the ability of TENS to modulate pain transmission and perception influenced by abnormal pain processing?
  • Prospective cohort study
  • Patients with chronic non specific pain (duration > 6 months), above 18 year, will be included. Patients are referred from the Pain Clinic of the University Hospital Maastricht (MUMC). Exclusion criteria are: a) pain due to cancer, b) the use of a cardiac pacemaker, c) pregnancy, d) neurological sensory deficits, e) language and/or cognitive inability to complete the health assessment questionnaires f) previous TENS for pain relief.
  • Patients receive a two week treatment period with TENS-treatment, as regular, at home after instruction. The frequency is set at 100 Hz and pulse duration at 250 μ sec. Patients have to use the TENS daily (minimal 4 times a day for 30 minutes).

Main study parameters/endpoints are decrease in amplitude of CHEPS in responders versus non-responders.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • referred for TENS treatment by a pain physician,
  • duration of pain > 6 months,
  • age above 18,
  • no current other treatment for pain besides pain medication. Patients are allowed to continue their regular pain medication (as described by physician) prior to the TENS treatment

排除标准

  • pain due to cancer,
  • the use of a cardiac pacemaker,
  • pregnancy,
  • neurological sensory deficits,
  • language and/or cognitive inability to complete the health assessment questionnaires
  • previous TENS for pain relief.

结局指标

主要结局

Contact heat evoked potentials (CHEPS)

时间窗: before and after two weeks treatment

次要结局

  • Severity of pijn on average past week(100mm VAS)(before and after two weeks treatment)

研究者

申办方类型
Other

研究点 (1)

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