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

Evaluating the Effectiveness of Osteopathy in the Management of Pain in Elderly People in Residential Care Facilities for the Elderly (EHPAD)

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.

Study Overview

• Status: Unknown
• Conditions: Osteopathy
• Intervention / Treatment: Other: osteopathy

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 Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 77420
      • Recruiting
      • Lea Gouaux
      • Contact: Gouaux Lea; Phone Number: 0614315262; Email: arc@eso-recher.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Real osteopathy	Other: osteopathy; osteopathic techniques
PLACEBO_COMPARATOR: Sham osteopathy	Other: osteopathy; osteopathic techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DOLOPLUS 2 score	Assessment of pain assessed by the behavioral scale	Every week after inclusion during 4 weeks

Collaborators and Investigators

• Sponsor: Léa Gouaux
• Collaborators: ESO Paris Recherche; BTP RMS

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2017
• Primary Completion (ANTICIPATED): December 31, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (ACTUAL): December 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: BTP RMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No