Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents

NCT ID: NCT06929598

Last Updated: 2025-09-04

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

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-04-30

Brief Summary

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The goal of this clinical trial is to learn if adding Shiatsu therapy to standard treatment can improve quality of life in children and adolescents with chronic pain that is not caused by inflammation. The main question it aims to answer is: Does Shiatsu therapy help improve the quality of life in children with long-lasting pain?

All participants will continue their regular treatment and will also:

* Receive a 30-minute Shiatsu session once a week for six weeks
* Complete questionnaires about their quality of life and family impact before, during, and after the treatment period

The study includes about 40 participants between the ages of 10 and 18, who are already being followed at the pediatric pain and rheumatology clinics at Tel Aviv Sourasky Medical Center.

Detailed Description

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Conditions

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Chronic Pain Chronic Pain Syndrome Chronic Pain and Comorbid Emotional Problems Chronic Pain, Psychogenic Chronic Pain, Widespread Fibromyalgia Fibromyalgia Syndrome Functional Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single-arm, prospective study evaluating the effects of adjunctive Shiatsu therapy on quality of life in children and adolescents with non-inflammatory chronic pain. All participants receive the same intervention without a comparison or control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Shiatsu Therapy Group

Participants will receive 30-minute Shiatsu therapy sessions once a week for 6 weeks, in addition to their usual pain management. The goal is to assess whether Shiatsu improves quality of life in children and adolescents with non-inflammatory chronic pain.

Group Type EXPERIMENTAL

Shiatsu Therapy

Intervention Type BEHAVIORAL

Participants will receive one 30-minute session of Shiatsu therapy per week for 6 weeks. Therapy will be provided by trained Shiatsu practitioners under a standardized protocol developed for this study.

Interventions

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Shiatsu Therapy

Participants will receive one 30-minute session of Shiatsu therapy per week for 6 weeks. Therapy will be provided by trained Shiatsu practitioners under a standardized protocol developed for this study.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children and adolescents aged 10-18 years
* Diagnosed with non-inflammatory chronic pain syndromes
* Actively followed by the Pediatric Rheumatology and/or Pediatric Pain Clinics at Tel Aviv Sourasky Medical Center (at least twice a year)
* Informed consent signed by at least one legal guardian (or both guardians in cases of separated parents)
* If participant is 16 years or older, they must also sign the informed consent

Exclusion Criteria

* Informed consent cannot be obtained from the participant or their legal guardians
* Legal guardians unable to provide informed consent
* Patients with severe conditions (e.g., bone metastasis)
* Patients unable to participate in Shiatsu therapy sessions
* Participation in Shiatsu therapy within 6 months prior to study enrollment
* Participant or legal guardian refuses participation
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

UNKNOWN

Sponsor Role collaborator

Dana-Dwek Children's Hospital

UNKNOWN

Sponsor Role collaborator

Tel Aviv University

OTHER

Sponsor Role lead

Responsible Party

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Eyal Cohen-Sela

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merav Heshin-Bekenstein, MD

Role: PRINCIPAL_INVESTIGATOR

Dana Dwek Children's Hospital, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel

Locations

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Tel Aviv Univrsity

Tel Aviv, Tel Aviv, Israel

Site Status NOT_YET_RECRUITING

Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Eyal Cohen-Sela, MD

Role: CONTACT

+972-3-6974247

Merav Heshin-Bekenstein, MD

Role: CONTACT

+972-3-6974247

Facility Contacts

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Research Authority Research Authority

Role: primary

972-3-6406250

Pediatric Rheumatology Unit

Role: primary

972-3-6974247

Other Identifiers

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0661-2222

Identifier Type: -

Identifier Source: org_study_id

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