Osteopathic Procedure on Pain in Palliative Care

Pain Clinical Trial

— OSTEOPAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939377
• Other study ID #: OSTEOPAL
• Secondary ID: 2018-A02655-50
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: June 2021
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients requiring a modification of analgesic molecule during the study.

• Clinical stability of the patient estimated during the duration of the study.

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Questionnaire and treatment
EVA questionnaire every day for 7 days. treatment (real or simulated) at J3 and J5

Locations

Country	Name	City	State
France	CHI Creteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 6
Secondary	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.	day 6
Secondary	QLQ (Quality of life questionnaire) C15 Pal score	Variation of the quality of life questionnaire (QLQ) C15 Pal score between D0 and D6	days 6