Evaluation of Osteopathic Protocol on Rachialgia (PO2)
Effect of Osteopathic Protocol in 2 Sessions (PO2) for Patients With Non-specific Spine: a Randomized Cross-over Clinical Trial
Rachialgia are among the most common reasons for consultation with the general practitioner in Europe. Most of the guidelines recommend spinal manipulation.
This study attempts to propose a solution with 2 parts: tests of induced pain that have a greater sensitivity than palpatory tests of movements and a comprehensive musculoskeletal treatment protocol.
The aim of this study is to evaluate the Osteopathic Protocol in 2 sessions (PO2).
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.
This study attempts to propose a solution to these two problems: by proposing for the clinical examination tests of induced pain that have a greater sensitivity than palpatory tests of movements, and a comprehensive musculoskeletal treatment protocol that should allow the study to be both reliable and valid in order to be true to osteopathic values and to accept the Evidence Based Medicine methodological evaluation model.
The aim of this study is to evaluate the Osteopathic Protocol in 2 sessions (PO2).
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Michel BOEUF
- 电话号码：+687 28 98 18
- 邮箱：michelboeuf@canl.nc
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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 |
|---|---|
|
实验性的：PO2 - Control
This arm will start with PO2, followed by Control. The PO2 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 PO2 but is not an active osteopathic treatment. A light touch will be made for fictitious normalizations. |
PO2 works on the principle that there is a concordance between the author's Pre-existing Torsion Pattern (PTP) and the rotatory direction of osteopathic dysfunctions in osteopathic hinges and pivots. The PO2 consists of two sessions of 30 minutes each, one week apart. A 13-item clinical examination is performed at the first session. It focuses on caused pain tests, and classifies patients in left or right PTP. During the first session 14 normalizations of joint, muscular, ligament and visceral dysfunctions are performed systematically. During the second session 10 normalizations of joint, muscular, ligament and visceral dysfunctions are performed . PO2 is an innovative osteopathic protocol for back pain. |
|
实验性的：Control - PO2
This arm will start with Control, followed by PO2. The PO2 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 PO2 but is not an active osteopathic treatment. A light touch will be made for fictitious normalizations. |
PO2 works on the principle that there is a concordance between the author's Pre-existing Torsion Pattern (PTP) and the rotatory direction of osteopathic dysfunctions in osteopathic hinges and pivots. The PO2 consists of two sessions of 30 minutes each, one week apart. A 13-item clinical examination is performed at the first session. It focuses on caused pain tests, and classifies patients in left or right PTP. During the first session 14 normalizations of joint, muscular, ligament and visceral dysfunctions are performed systematically. During the second session 10 normalizations of joint, muscular, ligament and visceral dysfunctions are performed . PO2 is an innovative osteopathic protocol for back pain. |
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 |
|---|---|---|
|
Change from baseline of pain level after 2 sessions
大体时间：Baseline and 2 weeks
|
Pain level will be collected using Visual Analog Scale (VAS) (from 0 to 10, where 10 means maximal intensity) before the first session of each protocol and one week after the second session (14 days).
|
Baseline and 2 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of pain improvement since previous visit
大体时间：Week 1 and week 2
|
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. |
Week 1 and week 2
|
|
Patient satisfaction
大体时间：Week 2
|
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. |
Week 2
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
PO2 osteopathic protocol的临床试验
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HonorHealth Research InstituteCantex Pharmaceuticals终止