Efficacy of Osteopathic Treatment on the Side Effects of Curative Treatments of Lymphoblastic Leukemia in Pediatrics

Lymphoblastic Leukemia Clinical Trial

— Leucosteo  

Official title:

Efficacy of Osteopathic Treatment on the Side Effects of Curative Treatments of Lymphoblastic Leukemia in Pediatrics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05664230
• Other study ID #: APHP220699
• Secondary ID: IDRCB: 2022-A012
• Status: Not yet recruiting
• Start date: January 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Benoit BRETHON, MD
• Phone: +33171282536
• Email: benoit.brethon[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: August 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• osteopathy
five osteopathy sessions

Locations

Country	Name	City	State
France	Robert Debré Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	HEDEN (Hetero-Evaluation Pain Child) score before and after each intervention	5 weeks
Secondary	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.	FPS-R (Face Pain Scale-Revised) score before and after each osteopathy session	5 weeks
Secondary	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).	PedsQL™ Questionnaire quality of life in paediatrics	5 weeks