Osteopathic Procedure on Pain in Palliative Care

NCT03939377 | Completed

• 2 other identifiers: OSTEOPAL2018-A02655-50
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Palliative; Osteopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dose of analgesic (g)

  day 6

• QLQ (Quality of life questionnaire) C15 Pal score

  days 6

Study Arms (2)

Osteopathy

EXPERIMENTAL

Management will be centered on the skull, the sacrum, the cranio-sacral axis, the entire visceral abdominal and thoracic system.

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.

Other: Questionnaire and treatment

Interventions

Questionnaire and treatment OTHER

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

Osteopathy; Simulate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients requiring a modification of analgesic molecule during the study.
• Clinical stability of the patient estimated during the duration of the study.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

CHI Creteil

Créteil, 94000, France

Location

MeSH Terms

Conditions

Pain

Interventions

Surveys and Questionnaires; Therapeutics

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 6, 2019
• Study Start: March 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)