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Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People (IPODE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03382236
Recruitment Status : Unknown
Verified December 2017 by Léa Gouaux, Ecole Supérieur d'Ostéopathie.
Recruitment status was:  Recruiting
First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
BTP RMS
ESO Paris Recherche
Information provided by (Responsible Party):
Léa Gouaux, Ecole Supérieur d'Ostéopathie

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteopathy Other: osteopathy Not Applicable

Detailed Description:
  • "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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People in Residential Care Facilities for the Elderly (EHPAD)
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Real osteopathy Other: osteopathy
osteopathic techniques
Placebo Comparator: Sham osteopathy Other: osteopathy
osteopathic techniques


Outcome Measures
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Primary Outcome Measures :
  1. DOLOPLUS 2 score [ Time Frame: Every week after inclusion during 4 weeks ]
    Assessment of pain assessed by the behavioral scale


Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382236


Locations
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France
Lea Gouaux Recruiting
Paris, Ile De France, France, 77420
Contact: Gouaux Lea    0614315262    arc@eso-recher.fr   
Sponsors and Collaborators
Léa Gouaux
BTP RMS
ESO Paris Recherche
More Information
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Responsible Party: Léa Gouaux, Attachée de recherche clinique, Ecole Supérieur d'Ostéopathie
ClinicalTrials.gov Identifier: NCT03382236    
Other Study ID Numbers: BTP RMS
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No