NCT07667426

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 objective of this bicentric study is to reevaluate the effectiveness of the two-session osteopathic protocol (PO2S), this time by another osteopath, as part of a multicenter validation program.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
May 2025Oct 2026

Study Start

First participant enrolled

May 15, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

June 25, 2026

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

June 18, 2026

Last Update Submit

June 18, 2026

Conditions

Keywords

Osteopathic Pain PO2S

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 - PO2S

EXPERIMENTAL

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.

Other: Osteopathic Protocol in 2 Sessions (PO2S)

Interventions

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 - PO2SPO2S - Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cabinet d'ostéopathie 23 quai Jules Ferry 98800 Nouméa

Noumea, South, 98800, New Caledonia

Location

Related Links

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, 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

June 18, 2026

First Posted

June 25, 2026

Study Start

May 15, 2025

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

June 25, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations