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

Osteopathy Clinical Trial

— IPODE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03382236
• Other study ID #: BTP RMS
• Status: Recruiting
• Phase: N/A
• First received: December 11, 2017
• Last updated: December 18, 2017
• Start date: January 3, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: December 2017
• Source: Ecole Supérieur d'Ostéopathie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteopathy

Intervention

Other:
• osteopathy
osteopathic techniques

Locations

Country	Name	City	State
France	Lea Gouaux	Paris	Ile De France

Sponsors (3)

Lead Sponsor	Collaborator
Léa Gouaux	BTP RMS, ESO Paris Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DOLOPLUS 2 score	Assessment of pain assessed by the behavioral scale	Every week after inclusion during 4 weeks