Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed (OSTEO)

July 13, 2022 updated by: Hospices Civils de Lyon

Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pierre-Bénite, France
        • Hôpital Lyon Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Osteopathy treatment
Other: Osteopathic treatment
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decreased pain intensity of 2 points measured by Analog Visual Scale (AVS) before and after the session
Time Frame: 15 days
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Decrease in analgesic consumption for pain related to immobilization
Time Frame: 15 days
15 days
Decreased 2 points of intensity of other symptoms associated before and after session measured with Edmonton Symptom Assessment System (ESAS).
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Marilène FILBET, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2018

Primary Completion (Actual)

February 2, 2020

Study Completion (Actual)

February 2, 2020

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

July 14, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL17_0723

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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