An interventional study of Osteopathic Protocol in 2 Sessions (PO2S) in Spine Injuries and Disorders, sponsored by Cabinet d'ostéopathie Michel Boeuf. Completed at 1 site in New Caledonia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Cabinet d'ostéopathie Michel Boeuf · Not applicable, Interventional, and Treatment
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).
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).
Cabinet d'ostéopathie Michel Boeuf is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Osteopathic Protocol in 2 Sessions (PO2S)
This arm will start with Control, followed by PO2S. 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.
Other: Osteopathic Protocol in 2 Sessions (PO2S)
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.
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).
Time frame: Baseline and 2 weeks
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.
Time frame: Week 1 and week 2
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.
Time frame: Week 2
Plan to share: No
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Ran from Oct 2022 to primary completion in Jun 2023, 8 months.
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Cabinet d'ostéopathie Michel Boeuf