Cancer Patient Confined in the BedOSTEONCT03440957
Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed
A study testing Osteopathic treatment in people with Cancer Patient Confined in the Bed, run by Hospices Civils de Lyon at 1 site in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patient Confined in the Bed
- What is being tested?
- Osteopathic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2018to 2 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cancer Patient Confined in the Bed
- Being tested
- Osteopathic treatment
- Keywords
- advanced cancer, osteopathy, pain, bedridden
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic treatmentOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| Osteopathy treatment | Other | Not described Receives: Other: Osteopathic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased pain intensity of 2 points measured by Analog Visual Scale (AVS) before and after the session
Measured: 15 days
Secondary outcomes (2)
Decrease in analgesic consumption for pain related to immobilization
Measured: 15 days
Decreased 2 points of intensity of other symptoms associated before and after session measured with Edmonton Symptom Assessment System (ESAS).
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start21 Feb 2018
- Primary completion2 Feb 2020
- Study completion2 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patient Confined in the BedStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilène FILBET, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440957
- Sponsor's protocol ID
- 69HCL17_0723
- Acronym
- OSTEO
- Status last verified
- Jul 2022
- First submitted
- 15 Feb 2018
- Last updated
- 14 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed Pilot Study
- ClinicalTrials.gov ID
- NCT03440957
- Acronym / sponsor ID
- OSTEO / 69HCL17_0723
- Conditions
- Cancer Patient Confined in the Bed
- Keywords
- advanced cancer, osteopathy, pain, bedridden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 2 Feb 2020 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteopathy treatment | Other | Other: Osteopathic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic treatmentThe 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 . | Other | Osteopathy treatment |
Primary outcome
Decreased pain intensity of 2 points measured by Analog Visual Scale (AVS) before and after the session
Time frame: 15 days
2 secondary outcomes
Decrease in analgesic consumption for pain related to immobilization
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilène FILBET, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic treatment in people with Cancer Patient Confined in the Bed, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased pain intensity of 2 points measured by Analog Visual Scale (AVS) before and after the session (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.