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

NCT05664230 | Unknown

• 2 other identifiers: APHP220699IDRCB: 2022-A01261-42
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoblastic Leukemia

Keywords

osteopathy

Outcome Measures

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

  5 weeks

Secondary Outcomes (2)

• 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

Interventions

osteopathy OTHER

five osteopathy sessions

Also known as: osteopathy session

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute lymphoblastic leukemia

You may qualify if:

• Patient managed and treated with a diagnosis of acute lymphoblastic leukemia
• Patient between 1 and 10 years of age
• Social security affiliation or entitlement
• Signature of informed consent by both parents

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Osteopathic Physicians

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physicians; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Benoit BRETHON, MD

  Assistant Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benoit BRETHON, MD

CONTACT

+33171282536; benoit.brethon@aphp.fr

Laurent STUBBE, MD

CONTACT

+33164614870; laurent.stubbe@eso-suposteo.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 23, 2022
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: December 23, 2022

Record last verified: 2022-10

Locations

FR (1)