Evaluation of Osteopathic Protocol on Rachialgia

Study Overview
=================
Brief Summary
-----------------
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
-----------------
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).

Official Title
-----------------
Effect of Osteopathic Protocol in 2 Sessions (PO2) for Patients With Non-specific Spine: a Randomized Cross-over Clinical Trial

Conditions
-----------------
Spine Injuries and Disorders

Intervention / Treatment
-----------------
* Other: PO2 osteopathic protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PO2 - Control<br>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. | Other: PO2 osteopathic protocol<br>* 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.<br>|
| Experimental: Control - PO2<br>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. | Other: PO2 osteopathic protocol<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of pain level after 2 sessions | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of pain improvement since previous visit | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteopathic, Pain, Spine