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

Not yet recruiting

• Conditions: Lymphoblastic Leukemia

• Registration Number: NCT05664230
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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 Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2022-12-16
• Last Update Submitted: 2022-12-16
• Study First Posted: 2022-12-23
• Last Update Posted: 2022-12-23
• Study Start: 2023-01-01
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Robert Debré Hospital; 🇫🇷 Paris, France