Spine Injuries and Disorders
Conditions
Keywords
Osteopathic Pain PO2S
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 objective of this bicentric study is to reevaluate the effectiveness of the two-session osteopathic protocol (PO2S), this time by another osteopath, as part of a multicenter validation program.
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. 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.
Interventions
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.
Sponsors
Cabinet d'ostéopathie Michel Boeuf
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of pain level after 2 sessions | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of pain improvement since previous visit | 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. |
| Patient satisfaction | 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 |
Countries
New Caledonia
Outcome results
None listed