跳至主要内容
临床试验/NCT05952167
NCT05952167
招募中
不适用

Evaluation of the Impact of Tractions vs. Placebo Tractions in Patients With Cervical Radiculopathy, Randomised Controlled Trial in a Single-blind Study

Centre Hospitalier Departemental Vendee15 个研究点 分布在 1 个国家目标入组 206 人2024年3月25日

概览

阶段
不适用
干预措施
Intensive cervical traction protocol - placebo
疾病 / 适应症
Radiculopathy
发起方
Centre Hospitalier Departemental Vendee
入组人数
206
试验地点
15
主要终点
Patients with a Neck Disability Index (NDI) score reduction of at least 7 points at M3.
状态
招募中
最后更新
17天前

概览

简要总结

Cervical radiculopathy is a common disease related to compression of the nerve roots of the spine (prevalence: 3.5/1000). Dysfunction and pain are the main repercussions and can lead to time off work and high costs in terms of treatment.

Second-line surgical treatments appear to be less effective and present risks of side effects. In the first instance, treatments are conservative and include medication but above all physiotherapy with manual therapy, muscle exercises and cervical traction. These cervical tractions performed by a physiotherapist require little equipment and are inexpensive compared with the surgical alternative. They involve stretching the cervical spine and soft tissues to open the intervertebral foramen and mobilise the facet joints.

Several authors have written summaries of their interest. Thoomes reports two studies and describes an absence of effect. In a meta-analysis, Romeo et al. added three more recent studies to the previous review and concluded that traction is effective, highlighting an "effect-dose" relationship. These recent results therefore seem to reverse the recommendations made barely two years later. Nevertheless, almost all the studies compared "manual therapy + exercises" with "manual therapy + exercises + cervical traction". Only Young et al. tested "manual therapy + exercises + cervical traction at an effective weight" compared to "manual therapy + exercises + cervical traction placebo at an ineffective weight". The study did not reveal any difference between the groups. However, several limitations appear in this study when comparing the protocol to studies that have shown efficacy. The main limitation is the low intensity (i.e. protocol with fewer sessions and longer duration). These clinical limitations may explain the lack of evidence of a positive outcome. Following on from a preliminary study evaluating an intensive cervical traction protocol over five days, and in order to discern the effect specific to the treatment (specific effect) and the effect independent of the nature of the treatment (contextual effect), the investigators wish to evaluate the impact of this intensive protocol by comparing it with placebo traction.

In current practice, treatment varies between establishments. The paucity of studies on cervical traction in radiculopathy has resulted in routine use being guided by habit rather than evidence. It remains a clinical question which raises a major issue requiring a robust experimental design. Ultimately, this study follows on from a preliminary study and is part of a comprehensive research project aimed at proposing new recommendations for the use of traction in patients suffering from cervical radiculopathy. The investigators are investigating the impact of an intensive traction vs. placebo traction protocol in patients with cervical radiculopathy.

注册库
clinicaltrials.gov
开始日期
2024年3月25日
结束日期
2031年9月25日
最后更新
17天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

入选标准

  • Patient over 18
  • Neck Disability Index ≥ 15/50
  • Presence of at least three of the four signs clinically validating the presence of cervical radiculopathy (Wainner et al. 2003)
  • a) upper limb nerve tension test A (ULNT1a): positive,
  • b) amplitude of cervical rotation on the side concerned: \< 60°,
  • c) positive cervical distraction test: relief
  • d) positive Spurling test: reproduction of symptoms.
  • Cervical radiculopathy diagnosed 3 to 24 months previously
  • Absence of cervical traction in the 5 years prior to inclusion
  • MRI or CT scan performed prior to hospitalisation in relation to current pathology

排除标准

  • Patients with vertebral artery pathology at the time of inclusion
  • Patients with myelopathy, cervical cancer, cervical fracture, cervical dislocation, cervical spondylolisthesis, spinal infection, symptomatic cervical pain without radiculopathy and/or cervical surgery in the 2 years prior to inclusion.
  • Patient participating in another clinical research protocol with an impact on the objectives of the research.
  • Patient who is pregnant, breastfeeding or able to procreate without effective contraception\*.
  • Patient under guardianship, curatorship or deprived of liberty
  • Patient under activated future protection mandate
  • Patient under family habilitation
  • Patient under court protection.

研究组 & 干预措施

Placebo mechanical cervical traction

干预措施: Intensive cervical traction protocol - placebo

Mechanical cervical traction

干预措施: Intensive cervical traction protocol

结局指标

主要结局

Patients with a Neck Disability Index (NDI) score reduction of at least 7 points at M3.

时间窗: At 3 months post cervical traction protocol

The minimum clinically important difference (MCID) was established at 7 points out of 50 by (Cleland et al. 2006).

研究点 (15)

Loading locations...

相似试验