Clinical trial NCT05574348: Evaluation of Osteopathic Protocol on Rachialgia
Official title: Effect of Osteopathic Protocol in 2 Sessions (PO2S) for Patients With Non-specific Spine: a Randomized Cross-over Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Injuries and Disorders
Keywords: Osteopathic
Pain
Spine
Lead sponsor: Cabinet d'ostéopathie Michel Boeuf
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 aim of this study is to evaluate the Osteopathic Protocol in 2 sessions (PO2).

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of pain level after 2 sessions
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Percentage of pain improvement since previous visit
timeFrame: Week 1 and week 2
measure: Patient satisfaction
timeFrame: Week 2
Other outcomes:
Locations:
city: Nouméa
country: New Caledonia
facility: Michel Boeuf
state: Sud
Study officials:
References: