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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

Osteopathic Procedure on Pain in Palliative Care

Clinicaltrials.gov identifier NCT03939377

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted January 30, 2020

Study Description

Brief 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.

  • Condition or Disease:Pain
  • Intervention/Treatment: Other: Questionnaire and treatment
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 80 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Other
  • 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
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Osteopathy
Management will be centered on the skull, the sacrum, the cranio-sacral axis, the entire visceral abdominal and thoracic system.
Other: Questionnaire and treatment
EVA questionnaire every day for 7 days. treatment (real or simulated) at J3 and J5
Placebo Comparator: Simulate
The simulated treatment will be characterized by placing the practitioner's hands on the patient in the areas tested without any intention of treatment.
Other: Questionnaire and treatment
EVA questionnaire every day for 7 days. treatment (real or simulated) at J3 and J5
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 1. 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
  • 2. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: Camille JUNG, MD 0157022268 camille.jung@chicreteil.fr

Locations

France
CHI Creteil
Créteil

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil

More Information
  • Responsible Party: Centre Hospitalier Intercommunal Creteil
  • ClinicalTrials.gov Identifier: NCT03939377 History of Changes
  • Other Study ID Numbers: OSTEOPAL, 2018-A02655-50
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: January 30, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Centre Hospitalier Intercommunal Creteil: Palliative Osteopathy