Evaluation of Osteopathic Protocol on Rachialgia

NCT05574348 | Completed

• 1 other identifier: PO2S
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Spine Injuries and Disorders

Keywords

Osteopathic; Pain; Spine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of pain improvement since previous visit

  Week 1 and week 2

• Patient satisfaction

  Week 2

Study Arms (2)

PO2S - Control

EXPERIMENTAL

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.

Other: Osteopathic Protocol in 2 Sessions (PO2S)

Control - PO2

EXPERIMENTAL

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.

Other: Osteopathic Protocol in 2 Sessions (PO2S)

Interventions

Osteopathic Protocol in 2 Sessions (PO2S) 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; PO2S - Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cabinet d'ostéopathie Michel Boeuf: lead

Study Sites (1)

Michel Boeuf

Noumea, Sud, 98800, New Caledonia

Location

MeSH Terms

Conditions

Disease; Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 10, 2022
• Study Start: October 15, 2022
• Primary Completion: June 15, 2023
• Study Completion: July 15, 2023
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)