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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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South
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Noumea, South, Ny Kaledonien, 98800
- Cabinet d'ostéopathie 23 quai Jules Ferry 98800 Nouméa
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: PO2S - Control
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.
|
PO2S arbejder ud fra princippet om, at der er en overensstemmelse mellem forfatterens Preferential Torsion Pattern (PTP) og rotationsretningen af osteopatiske dysfunktioner. PO2S består af to sessioner á 30 minutter hver med en uges mellemrum. En klinisk undersøgelse på 13 punkter udføres ved første session. Den fokuserer på forårsagede smertetests og klassificerer patienter i venstre eller højre PTP. I løbet af den første session udføres der systematisk 14 normaliseringer af led-, muskel-, ledbånds- og viscerale dysfunktioner. Under den anden session udføres 10 normaliseringer af led-, muskel-, ledbånds- og viscerale dysfunktioner. PO2S er en innovativ osteopatisk protokol mod rygsmerter. |
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Eksperimentel: Control - PO2S
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.
|
PO2S arbejder ud fra princippet om, at der er en overensstemmelse mellem forfatterens Preferential Torsion Pattern (PTP) og rotationsretningen af osteopatiske dysfunktioner. PO2S består af to sessioner á 30 minutter hver med en uges mellemrum. En klinisk undersøgelse på 13 punkter udføres ved første session. Den fokuserer på forårsagede smertetests og klassificerer patienter i venstre eller højre PTP. I løbet af den første session udføres der systematisk 14 normaliseringer af led-, muskel-, ledbånds- og viscerale dysfunktioner. Under den anden session udføres 10 normaliseringer af led-, muskel-, ledbånds- og viscerale dysfunktioner. PO2S er en innovativ osteopatisk protokol mod rygsmerter. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ændring fra baseline af smerteniveau efter 2 sessioner
Tidsramme: Baseline og 2 uger
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Smerteniveauet vil blive indsamlet ved hjælp af Visual Analog Scale (VAS) (fra 0 til 10, hvor 10 betyder maksimal intensitet) før den første session af hver protokol og en uge efter den anden session (14 dage).
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Baseline og 2 uger
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of pain improvement since previous visit
Tidsramme: Week 1 and week 2
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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.
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Week 1 and week 2
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Patient satisfaction
Tidsramme: Week 2
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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
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Week 2
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Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PO2S (2)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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