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