NCT03382236

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

December 11, 2017

Last Update Submit

December 18, 2017

Conditions

Osteopathy

Outcome Measures

Primary Outcomes (1)

  • DOLOPLUS 2 score

    Assessment of pain assessed by the behavioral scale

    Every week after inclusion during 4 weeks

Study Arms (2)

Real osteopathy

EXPERIMENTAL
Other: osteopathy

Sham osteopathy

PLACEBO COMPARATOR
Other: osteopathy

Interventions

osteopathyOTHER

osteopathic techniques

Real osteopathySham osteopathy

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lea Gouaux

Paris, Île-de-France Region, 77420, France

RECRUITING

MeSH Terms

Interventions

Osteopathic Physicians

Intervention Hierarchy (Ancestors)

PhysiciansHealth PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attachée de recherche clinique

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 22, 2017

Study Start

January 3, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

December 22, 2017

Record last verified: 2017-12

Locations

FR(1)