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

NCT ID: NCT05664230

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-08-01

Brief Summary

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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

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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).

Conditions

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Lymphoblastic Leukemia

Keywords

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osteopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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osteopathy

five osteopathy sessions

Intervention Type OTHER

Other Intervention Names

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osteopathy session

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benoit BRETHON, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Publique Hopitaux de Paris

Locations

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Robert Debré Hospital

Paris, , France

Site Status

Countries

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France

Central Contacts

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Benoit BRETHON, MD

Role: CONTACT

Phone: +33171282536

Email: [email protected]

Laurent STUBBE, MD

Role: CONTACT

Phone: +33164614870

Email: [email protected]

Facility Contacts

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Benoit BRETHON, MD

Role: primary

Other Identifiers

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IDRCB: 2022-A01261-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP220699

Identifier Type: -

Identifier Source: org_study_id