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CompletedNCT03440957OSTEOUpdated Jul 14, 2022

Osteopathy Treatment for Cancer Pain Related to the Confinement to Bed

An interventional study of Osteopathic treatment in Cancer Patient Confined in the Bed, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-14.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Staying confined in the bed is frequent at the end of life. The cancer patients can also experiment this situation, and consequences are painful, with pain increasing with the time. This pain are related to the joints stiffing , muscles mass decreasing, and tendons retractions . The non pharmacological approach associated with the conventional treatments can be interesting to assess in this frails patients.

02

Conditions studied

  • Cancer Patient Confined in the Bed

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Keywords

  • advanced cancer
  • osteopathy
  • pain
  • bedridden
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Man or woman
  • Aged 18 years or older
  • Having signed informed consent to participate in the study
  • Patient affiliated to a social security scheme
  • Patient with pain affecting the musculoskeletal system following prolonged bed rest
  • Capable to understand French
  • Capable of completing self-assessment scales

Exclusion criteria

Exclusion Criteria:

  • Patients with bone metastases at risk for the use of osteopathy
  • Patients under legal protection measures
  • Patients with cognitive impairment preventing self-evaluation
  • Patient who is considered too fragile or with a clinical condition too unstable by the doctor refer to be included in the study
  • Patients in the pre-agonic or agonic phase
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Other
    Osteopathy treatment

    Other: Osteopathic treatment

Interventions

  • OtherOsteopathic treatment

    The patients meeting the inclusions criteria will be informed of the study and an osteopathic treatment holistic ,involving all the body will be applied, three time with 2 days between the treatments .Each meeting with the practitioner will last around 40 minutes. The pain and symptoms assessment will be done before and after the treatment .

05

What researchers measure

Primary outcomes

  1. Decreased pain intensity of 2 points measured by Analog Visual Scale (AVS) before and after the session

    Time frame: 15 days

Secondary outcomes

  1. Decrease in analgesic consumption for pain related to immobilization

    Time frame: 15 days

  2. Decreased 2 points of intensity of other symptoms associated before and after session measured with Edmonton Symptom Assessment System (ESAS).

    Time frame: 15 days

06

Study locations

1 site
  • Hôpital Lyon Sud
    Pierre-Bénite, France
07

Registry details

Key details

Study ID
NCT03440957
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Feb 21, 2018
Primary completion
Feb 2, 2020
Completion
Feb 2, 2020
Last update
Jul 14, 2022

Study contacts

Marilène FILBET, MD
principal investigator · Hospices Civils de Lyon

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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