Clinical trial NCT05664230: Efficacy of Osteopathic Treatment on the Side Effects of Curative Treatments of Lymphoblastic Leukemia in Pediatrics
Official title: Efficacy of Osteopathic Treatment on the Side Effects of Curative Treatments of Lymphoblastic Leukemia in Pediatrics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoblastic Leukemia
Keywords: osteopathy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute lymphoblastic leukemia

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).

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 5 weeks
Secondary outcomes:
measure: 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.
timeFrame: 5 weeks
measure: 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).
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debré Hospital
Study officials:
affiliation: Assistant Publique Hopitaux de Paris
name: Benoit BRETHON, MD
role: PRINCIPAL_INVESTIGATOR
References: