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Completed

NCT Number: NCT03939377

Osteopathic Procedure on Pain in Palliative Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHI Creteil

Créteil, 94000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire and treatment

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Dose of analgesic (g)

    Time frame: day 6

    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.

  2. QLQ (Quality of life questionnaire) C15 Pal score

    Time frame: days 6

    Variation of the quality of life questionnaire (QLQ) C15 Pal score between D0 and D6

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study 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

Acronym: OSTEOPAL

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 6, 2019
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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