Evaluation of Osteopathic Protocol on Rachialgia, Bis (PO2S (2))
Second Study on the Osteopathic Protocol in 2 Sessions (PO2S) for Patients Suffering From Acute or Subacute Non-specific Back Pain: a Randomized Crossover Clinical Trial
研究概览
详细说明
Rachialgia, whether it is cervicalgia, chest pain or low back pain, are among the most common reasons for consultation with the general practitioner in Europe.
In 2018, the therapeutic strategies for non-specific acute and subacute spine are diverse based on country clinical practice guidelines. Recommendations are rest or maintenance of normal activity, medications, surgery, psychological support, physiotherapy, acupuncture and manipulations.
Most of the guidelines, notably from Germany, Belgium, France, England and the United States, recommend spinal manipulation. In general, it can be recommended alone, or accompanied by usual care, or integrated into a multimodal treatment program. May be recommended in acute, chronic or not recommended.
The strength of osteopathy is that it tries to understand the musculoskeletal balance as a whole.
However, the differences in recommendations can be explained by the weaknesses of osteopathy, which are related to a technical and methodological problem.
The first technical problem is at the level of osteopathic clinical examination. While much of this clinical examination is based on palpatory tests, there is evidence that these range of motion palpatory tests have low sensitivity regardless of the examiner's experience.
The second methodological problem is the use of protocols. study addresses two major challenges: first, by proposing clinical examination tests based on induced pain, which demonstrate greater sensitivity than traditional palpatory movement tests; and second, by applying a structured and reproducible musculoskeletal treatment protocol. This approach is designed to ensure both reliability and validity, in line with core osteopathic principles, while meeting the standards of Evidence-Based Medicine (EBM).
The objective of this bicentric study is to reassess the effectiveness of the Osteopathic Protocol in 2 Sessions (PO2S), as part of a broader multicenter validation process, this time applied by a different osteopath.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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South
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Noumea、South、新喀里多尼亚、98800
- Cabinet d'ostéopathie 23 quai Jules Ferry 98800 Nouméa
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients with acute or subacute cervico-dorsalgia or lumbo-dorsalgia (less than 3 months)
- Patients who gave their informed consent to participate in this study.
Exclusion Criteria:
- Patients whose specific spine is caused by inflammatory, tumor, infectious disease or back trauma in the past 3 months
- Patients with a history of back surgery and/or vertebral fracture in the past 6 months
- Patients with a motor disability related to the reason for consultation
- Pregnant women over six months.
- Patients not communicating or unable to understand the course of the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：PO2S - Control
This arm will start with PO2S, followed by Control.
The PO2S consists of two sessions of 30 minutes each, one week apart, composed of normalizations of joint, muscular, ligament and visceral dysfunctions .
Control is a treatment in 2 sessions that is like PO2S but is not an active osteopathic treatment.
A light touch will be made for fictitious normalizations.
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PO2S 的工作原理是作者的优先扭转模式 (PTP) 与骨病功能障碍的旋转方向之间存在一致性。 PO2S 包括两节课，每节课 30 分钟，间隔一周。 第一次检查时会进行 13 项临床检查。 它侧重于引起的疼痛测试，并对患者进行左 PTP 或右 PTP 分类。 在第一次治疗期间，系统地对关节、肌肉、韧带和内脏功能障碍进行了 14 次正常化治疗。 在第二次治疗期间，将进行 10 次关节、肌肉、韧带和内脏功能障碍的正常化。 PO2S 是一种治疗背痛的创新整骨疗法。 |
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实验性的：Control - PO2S
This arm will start with Control, followed by the PO2S.
PO2S consists of two sessions of 30 minutes each, one week apart, composed of normalizations of joint, muscular, ligament and visceral dysfunctions .
Control is a treatment in 2 sessions that is like PO2S but is not an active osteopathic treatment.
A light touch will be made for fictitious normalizations.
|
PO2S 的工作原理是作者的优先扭转模式 (PTP) 与骨病功能障碍的旋转方向之间存在一致性。 PO2S 包括两节课，每节课 30 分钟，间隔一周。 第一次检查时会进行 13 项临床检查。 它侧重于引起的疼痛测试，并对患者进行左 PTP 或右 PTP 分类。 在第一次治疗期间，系统地对关节、肌肉、韧带和内脏功能障碍进行了 14 次正常化治疗。 在第二次治疗期间，将进行 10 次关节、肌肉、韧带和内脏功能障碍的正常化。 PO2S 是一种治疗背痛的创新整骨疗法。 |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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2 次疗程后疼痛水平相对基线的变化
大体时间：基线和 2 周
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将在每个方案的第一次疗程之前和第二次疗程后一周（14 天）使用视觉模拟量表（VAS）（从 0 到 10，其中 10 表示最大强度）收集疼痛水平。
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基线和 2 周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Percentage of pain improvement since previous visit
大体时间：Week 1 and week 2
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The percent improvement will be used to assess the degree of improvement in pain experienced since the first visit.
It will be expressed in %, the caregiver asking the patient to quantify the percentage of pain improvement on a virtual scale ranging from 0 for no improvement to 100 for complete pain disappearance.
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Week 1 and week 2
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Patient satisfaction
大体时间：Week 2
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The satisfaction score will be used to assess patient satisfaction with treatment and management.
It will be calculated on a virtual scale ranging from 0 for zero satisfaction to 10 for a total satisfaction
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Week 2
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合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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