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Evaluation of Osteopathic Protocol on Rachialgia (PO2)

6. oktober 2022 oppdatert av: Cabinet d'ostéopathie Michel Boeuf

Effect of Osteopathic Protocol in 2 Sessions (PO2) for Patients With Non-specific Spine: a Randomized Cross-over Clinical Trial

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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

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).

Studietype

Intervensjonell

Registrering (Forventet)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PO2 - Control

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.
Annen: PO2 osteopathic protocol

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.
Eksperimentell: Control - PO2

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.
Annen: PO2 osteopathic protocol

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline of pain level after 2 sessions
Tidsramme: 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).
Baseline and 2 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of pain improvement since previous visit
Tidsramme: 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.
Week 1 and week 2
Patient satisfaction
Tidsramme: 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.
Week 2

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cabinet d'ostéopathie Michel Boeuf

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

15. oktober 2022

Primær fullføring (Forventet)

15. juni 2023

Studiet fullført (Forventet)

15. juli 2023

Datoer for studieregistrering

Først innsendt

4. oktober 2022

Først innsendt som oppfylte QC-kriteriene

6. oktober 2022

Først lagt ut (Faktiske)

10. oktober 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. oktober 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. oktober 2022

Sist bekreftet

1. oktober 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PO2

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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