Evaluation of Osteopathic Protocol on Rachialgia, Bis
PO2S (2)
Second Study on the Osteopathic Protocol in 2 Sessions (PO2S) for Patients Suffering From Acute or Subacute Non-specific Back Pain: a Randomized Crossover Clinical Trial
1 other identifier
interventional
50
1 country
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 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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2025
CompletedFirst Submitted
Initial submission to the registry
June 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 15, 2026
June 25, 2026
June 1, 2025
1.3 years
June 18, 2026
June 18, 2026
Conditions
Keywords
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
EXPERIMENTALThis 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.
Control - PO2S
EXPERIMENTALThis 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.
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.
Eligibility Criteria
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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