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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
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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