跳至主要内容
临床试验/NCT06669858
NCT06669858已完成2 期

Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis, a Pilot Study

Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Analogic Visual Scale of pain

研究概览

简要总结

Introduction : Low back pain represents a major public health issue. In some cases, surgery may be necessary, but it is not without consequences. Among these, we find pain that may require management in specialized centers as well as functional disability, particularly in cases of arthrodesis, thereby affecting the quality of life of patients. Objectives : To study the effectiveness of osteopathy in the post-surgical management of lumbo-sacral arthrodesis. Methods : A pilot study including 35 patients who underwent lumbo-sacral arthrodesis divided into 2 groups: standardized osteopathic treatment and sham. The protocol consists of 2 post-operative sessions (D2 3 and D90). The evaluated criteria were pain intensity using the VAS, functional disability with the Oswestry questionnaire, anxiety and depression with the HAD questionnaire, and analgesic consumption. Result : Compared to the sham group, the osteopathic treatment group exhibited a lack of significance in the VAS (p= NS), Oswestry (p= NS) and HAD (p= NS) scores. Analgesic consumption also demonstrated a lack of statistical significance (p= NS). Discussion : In this study, osteopathy did not show an impact on HAD, Oswestry, VAS scores, or analgesic consumption. Based on other articles, there seems to be a link between the effectiveness of osteopathy and the frequency of sessions. Thus, it might be interesting to repeat the study with a larger sample size, the use of other measurement tools, and an increase in session frequency to validate these results.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • having surgery in Institut de la Colonne Vertébrale
  • surgery of lumbosacral arthrodesis

排除标准

  • spine deformation
  • inflammatory rhumatim
  • neurodegenerative pathology
  • cognitive trouble
  • neoplasic pathology
  • surgery complication
  • second surgery
  • out of the study

结局指标

主要结局

Analogic Visual Scale of pain

时间窗: at day 0 pre surgery, day 2 post surgery, day 90 post surgery (pre and post intervention) and day 105 post surgery

Pain scale from 0 (no pain) to 10 (maximal pain).

次要结局

  • OSWESTRY(day 0 pre surgery - day 90 post surgery - day 105 post surgery)
  • Hospital Anxiety and Depression(day 0 pre surgery, day 90 post surgery)
  • Antalgic consumption(from day 0 to day 105)

研究者

发起方
Centre Européen d'Enseignement Supérieur de l'Ostéopathie de Lyon
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验