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Status unknownNCT05664230LeucosteoUpdated Dec 23, 2022

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

An observational study in Lymphoblastic Leukemia, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2022-12-23.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
15
Ages
1 Year to 10 Years
Sex
All
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Study 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.

Read the 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).

02

Conditions studied

03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 15 is below the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute lymphoblastic leukemia

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No

Interventions

  • Otherosteopathy

    five osteopathy sessions

    Also known as: osteopathy session

06

What researchers measure

Primary outcomes

  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.

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

    Time frame: 5 weeks

Secondary outcomes

  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.

    FPS-R (Face Pain Scale-Revised) score before and after each osteopathy session

    Time frame: 5 weeks

  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).

    PedsQL™ Questionnaire quality of life in paediatrics

    Time frame: 5 weeks

07

Study locations

1 site
  • Robert Debré Hospital
    Paris, 75019, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05664230
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Dec 23, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Jul 1, 2023 (estimated)
Completion
Aug 1, 2023 (estimated)
Last update
Dec 23, 2022

Study contacts

Benoit BRETHON, MD
Contact
benoit.brethon@aphp.fr
+33171282536
Laurent STUBBE, MD
Contact
laurent.stubbe@eso-suposteo.fr
+33164614870
Benoit BRETHON, MD
principal investigator · Assistant Publique Hopitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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