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NCT Number: NCT07667426

Evaluation of Osteopathic Protocol on Rachialgia, Bis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Spine Injuries and Disorders Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cabinet d'ostéopathie 23 quai Jules Ferry 98800 Nouméa

Noumea, South, 98800, New Caledonia

About this study

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. study addresses two major challenges: first, by proposing clinical examination tests based on induced pain, which demonstrate greater sensitivity than traditional palpatory movement tests; and second, by applying a structured and reproducible musculoskeletal treatment protocol. This approach is designed to ensure both reliability and validity, in line with core osteopathic principles, while meeting the standards of Evidence-Based Medicine (EBM).

The objective of this bicentric study is to reassess the effectiveness of the Osteopathic Protocol in 2 Sessions (PO2S), as part of a broader multicenter validation process, this time applied by a different osteopath.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline of pain level after 2 sessions

    Time frame: Baseline and 2 weeks

    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).

Secondary outcomes

  1. Percentage of pain improvement since previous visit

    Time frame: Week 1 and week 2

    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.

  2. Patient satisfaction

    Time frame: Week 2

    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

Sponsors and collaborators

Lead sponsor

Cabinet d'ostéopathie Michel Boeuf

Other

Registry information

Official study title

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

Acronym: PO2S (2)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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