Evaluation of Osteopathic Protocol on Rachialgia (PO2)
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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Michel BOEUF
- Numero di telefono: +687 28 98 18
- Email: michelboeuf@canl.nc
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
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. |
|
Sperimentale: 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. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline of pain level after 2 sessions
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of pain improvement since previous visit
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PO2
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su PO2 osteopathic protocol
-
Hospital for Special Surgery, New YorkReclutamentoChirurgia dell'anca | Uso di oppioidi | AgopunturaStati Uniti
-
University Hospital, AngersCompletato
-
Insel Gruppe AG, University Hospital BernReclutamento
-
Erasme University HospitalTerminatoMalattia cardiovascolare | Fattore di rischio cardiovascolare | Disordine del sonno; Relativo alla respirazione | Complicanza cardiovascolareBelgio
-
Epitel, Inc.University of Colorado, Denver; National Institute of Neurological Disorders... e altri collaboratoriIscrizione su invito
-
M.D. Anderson Cancer CenterAttivo, non reclutanteNeoplasie a cellule emopoietiche e linfoidi | Tumori solidi maligni | Sindrome da lisi tumoraleStati Uniti