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Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People

NCT ID: NCT03382236

Last Updated: 2017-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-03

Study Completion Date

2018-12-31

Brief Summary

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This type of study can have an impact on public health policy and help improve the management of pain in people with EHPAD; Propose better use of drug treatments and non-pharmacological methods such as osteopathy; Help structuring the healthcare sector.

Detailed Description

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* "Osteopathy" group: 3 osteopathy sessions of 45 min with one session every 3 weeks at S2, S5 and S8. Fascial osteopathic techniques performed will consist of gentle and non-impulsive manipulation
* "Simulated" group: 3 simulated osteopathy sessions lasting 45 minutes, one session every 3 weeks at S2, S5 and S8. The techniques performed will consist of an application of the hands to different anatomical regions than the group "osteopathy" without therapeutic intention, that is to say without tissue tensioning.

The pain will be assessed at inclusion (S0) and at the end of the procedure (S12) by the head physician, the coordinating physician or the psychomotor therapist, ignoring the assignment group of the subject and before each session. osteopathy (at S2, S5 and S8) by a nurse or psychomotor also ignoring the patient's assignment group.

Both groups will continue to benefit from their usual allopathic management and recommendations.

Patients will not be aware of the treatment received (osteopathy or simulated) and will be randomized by a computer server.

Conditions

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Osteopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Real osteopathy

Group Type EXPERIMENTAL

osteopathy

Intervention Type OTHER

osteopathic techniques

Sham osteopathy

Group Type PLACEBO_COMPARATOR

osteopathy

Intervention Type OTHER

osteopathic techniques

Interventions

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osteopathy

osteopathic techniques

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients older than 75 years
* Patients Residing in Accommodation Facilities for Dependent Old People
* A score measured by the DOLOPLUS 2 Scale at least 7/30 at the start of the study
* For patients in capacity and autonomous: Patients informed and having signed a free and informed consent.

For non-capable patients with a trusted person and / or guardian: Informed patients whose confidant or guardian has been informed and has signed free and informed consent.

\- Affiliated to a social security scheme (beneficiary or beneficiary)

Exclusion Criteria

* Absence of pain
* Medical contraindication known to the practice of osteopathy with fascial aim (advanced degenerative bone disease, metastatic cancer)
* Osteopathic treatment in the last six months
* Patients under curators
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BTP RMS

UNKNOWN

Sponsor Role collaborator

ESO Paris Recherche

OTHER

Sponsor Role collaborator

Léa Gouaux

OTHER

Sponsor Role lead

Responsible Party

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Léa Gouaux

Attachée de recherche clinique

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Lea Gouaux

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Gouaux Lea

Role: primary

Other Identifiers

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BTP RMS

Identifier Type: -

Identifier Source: org_study_id