Back to resultsOsteopathy 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
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
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
NCT ID
NCT03440957
First Posted
February 15, 2018
Last Updated
July 13, 2022
Sponsor
Hospices Civils de Lyon
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
Learn more about this trial
Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed
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