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Clinical Trials/NCT05664230
NCT05664230
Not yet recruiting
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country15 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphoblastic Leukemia
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
15
Locations
1
Primary Endpoint
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.
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
August 1, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Time Frame: 5 weeks

HEDEN (Hetero-Evaluation Pain Child) score before and after each intervention

Secondary Outcomes

  • 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)
  • 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)

Study Sites (1)

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