Evaluation of Osteopathic Protocol on Rachialgia

NCT ID: NCT05574348

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2023-07-15

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Spine Injuries and Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Osteopathic Protocol in 2 Sessions (PO2S)

Intervention Type OTHER

PO2S works on the principle that there is a concordance between the author's Preferential Torsion Pattern (PTP) and the rotatory direction of osteopathic dysfunctions.

The PO2S 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 .

PO2S is an innovative osteopathic protocol for back pain.

Control - PO2

This arm will start with Control, followed by PO2S. 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.

Group Type EXPERIMENTAL

Osteopathic Protocol in 2 Sessions (PO2S)

Intervention Type OTHER

PO2S works on the principle that there is a concordance between the author's Preferential Torsion Pattern (PTP) and the rotatory direction of osteopathic dysfunctions.

The PO2S 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 .

PO2S is an innovative osteopathic protocol for back pain.

Interventions

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Osteopathic Protocol in 2 Sessions (PO2S)

PO2S works on the principle that there is a concordance between the author's Preferential Torsion Pattern (PTP) and the rotatory direction of osteopathic dysfunctions.

The PO2S 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 .

PO2S is an innovative osteopathic protocol for back pain.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cabinet d'ostéopathie Michel Boeuf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Michel Boeuf

Noumea, Sud, New Caledonia

Site Status

Countries

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New Caledonia

Other Identifiers

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PO2S

Identifier Type: -

Identifier Source: org_study_id

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