PainOSTEOPALNCT03939377
Osteopathic Procedure on Pain in Palliative Care
A study testing Questionnaire and treatment in people with Pain, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
The culture of the palliative is anchored more and more in France. In 2009, nearly 9 out of 10 French people (89%) believe that palliative care can reduce the suffering of people at the end of their lives. Despite the rise of palliative care in France, their access is not homogeneous between regions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Questionnaire and treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 1 May 2021
- 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
- Major patient (age> 18) male or female
- Patient hospitalized or admitted to a day hospital that can be followed
- EVA between 40/100 and 60/100
- Signed informed consent
Who cannot join
- Patients requiring a modification of analgesic molecule during the study.
- Clinical stability of the patient estimated during the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Osteopathic Procedure in the Management of Pain in Palliative Care Patients in a Mobile Palliative Care Support Team (EMASP): Controlled, Randomized, Single-blind Study
The culture of the palliative is anchored more and more in France. In 2009, nearly 9 out of 10 French people (89%) believe that palliative care can reduce the suffering of people at the end of their lives. Despite the rise of palliative care in France, their access is not homogeneous between regions. In 2010, it is estimated that 2 French out of 3 likely to receive palliative care could not access it. Palliative care remains essential at the end of the patient's life, as well as for the family and caregivers.
The French government has put in place three national palliative care development programs: 2002-2005, 2008-2012, 2015-2018. The last program has unlocked a budget of 190 million euros for their development. It has been estimated from Social Security reimbursements, that the costs per patient over their last years of life are 26,000 euros, for a total of 13.5 million euros.
Read more
One of the most important aspects of palliative care is the comfort of the patients as well as their feelings in the care.
In order to best meet the expectations of cancer patients, some offer early palliative care that is effective in improving both the quality of life of the patient and its life expectancy.
Osteopathy is a manual alternative medicine whose goal is to restore the lack of mobility of tissues. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in the reduction of pain in adult patients in palliative care.
- Conditions
- Pain
- Being tested
- Questionnaire and treatment
- Keywords
- Palliative, Osteopathy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and treatmentOther
EVA questionnaire every day for 7 days. treatment (real or simulated) at J3 and J5
| Study group | Role | What they receive |
|---|---|---|
| Osteopathy | Experimental | Management will be centered on the skull, the sacrum, the cranio-sacral axis, the entire visceral abdominal and thoracic system. Receives: Other: Questionnaire and treatment |
| Simulate | Placebo comparator | The simulated treatment will be characterized by placing the practitioner's hands on the patient in the areas tested without any intention of treatment. Receives: Other: Questionnaire and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (Visual Analog Scale) evaluation (0 to 100)
Evolution of the score of the Visual Analogue Scale (VAAS) on 100 between D0 and D6 and D0 and D1, D0 and D2, D0 and D3, D0 and D4, D0 and D5
Measured: day 6
Secondary outcomes (2)
Dose of analgesic (g)
Variation of the analgesic intake between D0 and D6 and D0 and D1, J1 and D2, J2 and D3, D3 and D4, D4 and D5, D5 and D6.
Measured: day 6
QLQ (Quality of life questionnaire) C15 Pal score
Variation of the quality of life questionnaire (QLQ) C15 Pal score between D0 and D6
Measured: days 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Mar 2019
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939377
- Sponsor's protocol ID
- OSTEOPAL
- Other IDs
- 2018-A02655-50
- Acronym
- OSTEOPAL
- Status last verified
- Jun 2021
- First submitted
- 3 May 2019
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Osteopathic Procedure in the Management of Pain in Palliative Care Patients in a Mobile Palliative Care Support Team (EMASP): Controlled, Randomized, Single-blind Study
- ClinicalTrials.gov ID
- NCT03939377
- Acronym / sponsor ID
- OSTEOPAL / OSTEOPAL
- Conditions
- Pain
- Keywords
- Palliative, Osteopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 6 May 2019 (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.
The culture of the palliative is anchored more and more in France. In 2009, nearly 9 out of 10 French people (89%) believe that palliative care can reduce the suffering of people at the end of their lives. Despite the rise of palliative care in France, their access is not homogeneous between regions. In 2010, it is estimated that 2 French out of 3 likely to receive palliative care could not access it. Palliative care remains essential at the end of the patient's life, as well as for the family and caregivers.
The French government has put in place three national palliative care development programs: 2002-2005, 2008-2012, 2015-2018. The last program has unlocked a budget of 190 million euros for their development. It has been estimated from Social Security reimbursements, that the costs per patient over their last years of life are 26,000 euros, for a total of 13.5 million euros.
One of the most important aspects of palliative care is the comfort of the patients as well as their feelings in the care.
In order to best meet the expectations of cancer patients, some offer early palliative care that is effective in improving both the quality of life of the patient and its life expectancy.
Osteopathy is a manual alternative medicine whose goal is to restore the lack of mobility of tissues. It can be used as a complementary treatment when a specific support is put in place. The purpose of this study is to examine the effectiveness of osteopathy in the reduction of pain in adult patients in palliative care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathy | Experimental | Other: Questionnaire and treatmentManagement will be centered on the skull, the sacrum, the cranio-sacral axis, the entire visceral abdominal and thoracic system. |
| Simulate | Placebo comparator | Other: Questionnaire and treatmentThe simulated treatment will be characterized by placing the practitioner's hands on the patient in the areas tested without any intention of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patient (age> 18) male or female
- Patient hospitalized or admitted to a day hospital that can be followed
- EVA between 40/100 and 60/100
- Signed informed consent
Key exclusion criteria (2 listed)
- Patients requiring a modification of analgesic molecule during the study.
- Clinical stability of the patient estimated during the duration of the study.
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 |
|---|---|---|
| Questionnaire and treatmentEVA questionnaire every day for 7 days. treatment (real or simulated) at J3 and J5 | Other | Osteopathy, Simulate |
Primary outcome
VAS (Visual Analog Scale) evaluation (0 to 100)
Time frame: day 6
Evolution of the score of the Visual Analogue Scale (VAAS) on 100 between D0 and D6 and D0 and D1, D0 and D2, D0 and D3, D0 and D4, D0 and D5
2 secondary outcomes
Dose of analgesic (g)
Time frame: day 6
QLQ (Quality of life questionnaire) C15 Pal score
Time frame: days 6
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 23 Jun 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and treatment in people with Pain, run by Centre Hospitalier Intercommunal Creteil 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 4 inclusion and 2 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 23 Jun 2021. 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. Some participants in this study may receive a placebo. 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?
VAS (Visual Analog Scale) evaluation (0 to 100) (time frame: day 6). 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 23 Jun 2021.