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Trial Title:
Efficacy of Osteopathic Treatment on the Side Effects of Curative Treatments of Lymphoblastic Leukemia in Pediatrics
NCT ID:
NCT05664230
Condition:
Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Conditions: Keywords:
osteopathy
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
osteopathy
Description:
five osteopathy sessions
Other name:
osteopathy session
Summary:
During the curative treatment of cancer, pain often remains the dominant symptom
affecting the physical and psychological state of the patient.
Osteopathy is an exclusively manual practice whose goal is to compensate for mobility
dysfunctions of the tissues of the human body. It can be used as a complementary
treatment for cancer pain when pain medications are not enough.
The aim of this study is to examine the effectiveness of osteopathy in reducing pain
intensity and improving quality of life in patients treated for pediatric acute
lymphoblastic leukemia.
Detailed description:
During the curative treatment of cancer, pain often remains the dominant symptom
affecting the physical and psychological state of the patient.
Osteopathy is an exclusively manual practice whose goal is to compensate for mobility
dysfunctions of the tissues of the human body. It can be used as a complementary
treatment for cancer pain when pain medications are not enough.
The aim of this study is to examine the effectiveness of osteopathy in reducing pain
intensity and improving quality of life in patients treated for pediatric acute
lymphoblastic leukemia.
Primary objective :
To evaluate the effectiveness of five osteopathy sessions at regular intervals on the
characteristics of the pain felt in patients aged 1 to 10 years treated for acute
lymphoblastic leukemia using the HEDEN scale (Hetero-Evaluation Pain Child).
Criteria for eligibility:
Study pop:
Patients with acute lymphoblastic leukemia
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patient managed and treated with a diagnosis of acute lymphoblastic leukemia
- Patient between 1 and 10 years of age
- Patient with pain at inclusion, or pain at diagnosis related to leukemia
- Social security affiliation or entitlement
- Signature of informed consent by both parents
Exclusion Criteria:
- No pain reported at the time of management or diagnosis
- Surgery less than 30 days old
- Patient with another contraindication to osteopathic treatment (worsening of the
condition, bleeding syndrome), or a psychiatric pathology that prevents the scales
from being used.
Gender:
All
Minimum age:
1 Year
Maximum age:
10 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Robert Debré Hospital
Address:
City:
Paris
Zip:
75019
Country:
France
Contact:
Last name:
Benoit BRETHON, MD
Phone:
+33171282536
Email:
benoit.brethon@aphp.fr
Start date:
January 1, 2023
Completion date:
August 1, 2023
Lead sponsor:
Agency:
Assistance Publique - Hôpitaux de Paris
Agency class:
Other
Source:
Assistance Publique - Hôpitaux de Paris
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05664230
