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Evaluation of Osteopathic Protocol on Rachialgia (PO2)

Primary Purpose

Spine Injuries and Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PO2 osteopathic protocol
Sponsored by
Cabinet d'ostéopathie Michel Boeuf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spine Injuries and Disorders focused on measuring Osteopathic, Pain, Spine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    PO2 - Control

    Control - PO2

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    October 4, 2022
    Last Updated
    October 6, 2022
    Sponsor
    Cabinet d'ostéopathie Michel Boeuf
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05574348
    Brief Title
    Evaluation of Osteopathic Protocol on Rachialgia
    Acronym
    PO2
    Official Title
    Effect of Osteopathic Protocol in 2 Sessions (PO2) for Patients With Non-specific Spine: a Randomized Cross-over Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2022 (Anticipated)
    Primary Completion Date
    June 15, 2023 (Anticipated)
    Study Completion Date
    July 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cabinet d'ostéopathie Michel Boeuf

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spine Injuries and Disorders
    Keywords
    Osteopathic, Pain, Spine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PO2 - Control
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control - PO2
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    PO2 osteopathic protocol
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from baseline of pain level after 2 sessions
    Description
    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).
    Time Frame
    Baseline and 2 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage of pain improvement since previous visit
    Description
    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.
    Time Frame
    Week 1 and week 2
    Title
    Patient satisfaction
    Description
    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.
    Time Frame
    Week 2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michel BOEUF
    Phone
    +687 28 98 18
    Email
    michelboeuf@canl.nc

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Evaluation of Osteopathic Protocol on Rachialgia

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