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

Primary Purpose

Cancer Patient Confined in the Bed

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteopathic treatment
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Patient Confined in the Bed focused on measuring advanced cancer, osteopathy, pain, bedridden

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Lyon Sud

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Osteopathy treatment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2018
Last Updated
July 13, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03440957
Brief Title
Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed
Acronym
OSTEO
Official Title
Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
February 2, 2020 (Actual)
Study Completion Date
February 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Patient Confined in the Bed
Keywords
advanced cancer, osteopathy, pain, bedridden

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathy treatment
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Osteopathic treatment
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Decreased pain intensity of 2 points measured by Analog Visual Scale (AVS) before and after the session
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Decrease in analgesic consumption for pain related to immobilization
Time Frame
15 days
Title
Decreased 2 points of intensity of other symptoms associated before and after session measured with Edmonton Symptom Assessment System (ESAS).
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilène FILBET, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Lyon Sud
City
Pierre-Bénite
Country
France

12. IPD Sharing Statement

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Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed

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