Leucosteo: Efficacy of Osteopathic Treatment on the Side Effects of Curative Treatments of Lymphoblastic Leukemia in Pediatrics
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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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).
Study Design
Outcome Measures
Primary Outcome Measures
- Evaluate the effectiveness of 5 weekly osteopathy sessions at regular intervals from week 1 to week 5 on the characteristics of the pain felt in patients aged 1 to 10 years treated for acute lymphoblastic leukemia using the HEDEN scale. [5 weeks]
HEDEN (Hetero-Evaluation Pain Child) score before and after each intervention
Secondary Outcome Measures
- Evaluate the effectiveness of 5 weekly osteopathy sessions at regular intervals from week 1 to week 5 on the intensity of the pain felt in patients aged 4 to 10 years treated for acute lymphoblastic leukemia using the face scale: FPS -R. [5 weeks]
FPS-R (Face Pain Scale-Revised) score before and after each osteopathy session
- To study the variations in quality of life at inclusion and at the end of the study using the PedsQL™ (questionnaire quality of life in paediatrics). [5 weeks]
PedsQL™ Questionnaire quality of life in paediatrics
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient managed and treated with a diagnosis of acute lymphoblastic leukemia
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Patient between 1 and 10 years of age
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Patient with pain at inclusion, or pain at diagnosis related to leukemia
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Social security affiliation or entitlement
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Signature of informed consent by both parents
Exclusion Criteria:
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No pain reported at the time of management or diagnosis
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Surgery less than 30 days old
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Patient with another contraindication to osteopathic treatment (worsening of the condition, bleeding syndrome), or a psychiatric pathology that prevents the scales from being used.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Robert Debré Hospital | Paris | France | 75019 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Benoit BRETHON, MD, Assistant Publique Hopitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP220699
- IDRCB: 2022-A01261-42