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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05664230
Collaborator
(none)
15
1
7
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: osteopathy

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 Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Efficacy of Osteopathic Treatment on the Side Effects of Curative Treatments of Lymphoblastic Leukemia in Pediatrics
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Robert Debré Hospital Paris France 75019

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Benoit BRETHON, MD, Assistant Publique Hopitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05664230
Other Study ID Numbers:
  • APHP220699
  • IDRCB: 2022-A01261-42
First Posted:
Dec 23, 2022
Last Update Posted:
Dec 23, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Assistance Publique - Hôpitaux de Paris
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 23, 2022