NCT02584049

Brief Summary

The purpose of this study is to evaluate effects of Osteopathic Treatment in the Management of Care-induced pain in Elderly care, in Follow-up care and Rehabilitation Geriatric. The investigators assume that the application of a procedure based on osteopathic fascial techniques in elderly care in Suite and Geriatric Rehabilitation ( SSRG ) suffering from pain of nursing care, could reduce the painful phenomenon having systemic action, and improve tissue engineering, trophicity viscera and the neurovascular supply .

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable pain

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

December 2, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

October 20, 2015

Last Update Submit

July 5, 2023

Conditions

Pain

Keywords

Osteopathic treatmentCare-induced PainPainElderly

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Care-induced Pain assessed by Behavioural Scale

    Behavioural Scale to Evaluate Pain in Non-communicating Adults (ECPA)

    Every week after inclusion during 4 weeks

Secondary Outcomes (2)

  • Evaluation of variation in the Consumption of Analgesics (frequency, dose, type)

    Every day from inclusion during 4 weeks

  • Evaluation of Pain

    4 weeks

Study Arms (2)

Osteopathy

ACTIVE COMPARATOR

3 sessions of Osteopathic treatment in addition to the usual follow

Other: Osteopathy

Sham osteopathy

SHAM COMPARATOR

3 sessions of Sham osteopathy treatment in addition to the usual follow

Other: Sham osteopathy

Interventions

OsteopathyOTHER

3 sessions of osteopathy during 60 minutes each

Osteopathy
Sham osteopathyOTHER

3 sessions of sham osteopathy during 60 minutes each

Sham osteopathy

Eligibility Criteria

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

You may qualify if:

  • Patients aged over 75 years ;
  • Patients residing in Suite Care service and Geriatric Rehabilitation with pain induced by the nursing care;
  • Pain intensity measured by the Behavioral Assessment Scale of pain in the Aged Person ( ECPA) at least 8/32 within five days before the start of the study;
  • Patients having informed and signed a free and informed consent ;
  • Affiliated to social security scheme (beneficiary or assignee ) .

You may not qualify if:

  • Medical contraindication to the practice of osteopathy ;
  • Osteopathic treatment during the past year ;
  • Patients under tutorship and curatorship .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Intercommunal Hospital Group of Vexin - Geriatric care and rehabilitation department

Marines, 95640, France

Location

René Dubos Hospital - Geriatric care and rehabilitation department

Pontoise, Île-de-France Region, 95303, France

Location

MeSH Terms

Conditions

Pain

Interventions

Osteopathic Physicians

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhysiciansHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Martine MERCERON, PH

    René Dubos Hospital (PONTOISE-FRANCE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 22, 2015

Study Start

December 2, 2015

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)