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临床试验/NCT00325312
NCT00325312已完成2 期

Evaluation of the Efficacy of Subcutaneous Carbon Dioxide Insufflations for Treating Acute Non Specific Neck Pain in General Practice

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2001年1月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
114
试验地点
1
主要终点
time to neck pain relief

研究概览

简要总结

The purpose of the trial is to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound.

详细描述

Subcutaneous carbon dioxide insufflations popular in Central und Eastern Europe are a safe and inexpensive treatment modality in complementary medicine and are used mainly in musculoskeletal pain and vascular conditions. However, no rigorous trial exists on their efficacy.

The study is designed as a double blind sham controlled randomized trial to evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound.Since acute non specific neck pain is often self limiting, speed of recovery rather than outcome at fixed points in time is evaluated.

Participants receive either a maximum number of 9 subcutaneous carbon dioxide insufflations or a maximum number of 9 sham ultrasound administered by 4 therapists in a randomized order, thrice weekly. Carbon dioxide gas is insufflated subcutaneously at the locations of neck muscle tenderness. Per tender location 25 ml carbon dioxide gas is administered.

Primary outcome measure is recorded daily by means of a diary. Analysis is done by intention to treat. Differences in time curves are tested using the logrank test. Time curves are graphically displayed by a 1 minus survival Kaplan-Meier plot.

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

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •participants must report neck pain lasting for less than 7 days
  • •participants must report a current pain intensity of ≥ 40 mm on a 100 mm visual analogue scale.
  • •participants must state local neck muscles tenderness during clinical examination at one or more locations

排除标准

  • •neck pain of specific etiology (e.g., radiculopathy, infection, inflammation, primary tumor, or metastases)
  • •whiplash injury
  • •former neck surgery
  • •pregnancy
  • •breast feeding.

结局指标

主要结局

time to neck pain relief

次要结局

  • time to a 50% reduction in pain intensity
  • affective pain
  • sensory pain
  • pain intensity
  • treatment failure
  • recurrence of neck pain

研究者

发起方
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
申办方类型
Other Gov

研究点 (1)

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