NCT03440957

Brief Summary

Staying confined in the bed is frequent at the end of life. The cancer patients can also experiment this situation, and consequences are painful, with pain increasing with the time. This pain are related to the joints stiffing , muscles mass decreasing, and tendons retractions . The non pharmacological approach associated with the conventional treatments can be interesting to assess in this frails patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 15, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

February 21, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2020

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

1.9 years

First QC Date

February 15, 2018

Last Update Submit

July 13, 2022

Conditions

Keywords

advanced cancerosteopathypainbedridden

Outcome Measures

Primary Outcomes (1)

  • Decreased pain intensity of 2 points measured by Analog Visual Scale (AVS) before and after the session

    15 days

Secondary Outcomes (2)

  • Decrease in analgesic consumption for pain related to immobilization

    15 days

  • Decreased 2 points of intensity of other symptoms associated before and after session measured with Edmonton Symptom Assessment System (ESAS).

    15 days

Study Arms (1)

Osteopathy treatment

OTHER
Other: Osteopathic treatment

Interventions

The patients meeting the inclusions criteria will be informed of the study and an osteopathic treatment holistic ,involving all the body will be applied, three time with 2 days between the treatments .Each meeting with the practitioner will last around 40 minutes. The pain and symptoms assessment will be done before and after the treatment .

Osteopathy treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or woman
  • Aged 18 years or older
  • Having signed informed consent to participate in the study
  • Patient affiliated to a social security scheme
  • Patient with pain affecting the musculoskeletal system following prolonged bed rest
  • Capable to understand French
  • Capable of completing self-assessment scales

You may not qualify if:

  • Patients with bone metastases at risk for the use of osteopathy
  • Patients under legal protection measures
  • Patients with cognitive impairment preventing self-evaluation
  • Patient who is considered too fragile or with a clinical condition too unstable by the doctor refer to be included in the study
  • Patients in the pre-agonic or agonic phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lyon Sud

Pierre-Bénite, France

Location

MeSH Terms

Conditions

Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Marilène FILBET, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 22, 2018

Study Start

February 21, 2018

Primary Completion

February 2, 2020

Study Completion

February 2, 2020

Last Updated

July 14, 2022

Record last verified: 2022-07

Locations