Actively Recruiting

Phase Not Applicable
Age: 10Years - 18Years
All Genders
ID06929598

The Efficacy of Adjunctive Shiatsu Therapy for Non-Inflammatory Chronic Pain in Pediatric Patients: A Single-Arm Prospective Trial

Led by Tel Aviv University · Updated on 2025-09-04

40

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

T

Tel Aviv University

Lead Sponsor

T

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding Shiatsu therapy to standard treatment can improve the quality of life in children and adolescents aged 10 to 18 years who have chronic pain that is not caused by inflammation. The study focuses on understanding if weekly Shiatsu sessions can help those with long-lasting pain conditions such as fibromyalgia and functional pain. About 40 participants who are already being treated at pediatric pain and rheumatology clinics will take part in this trial. Participants will receive one 30-minute Shiatsu therapy session each week for six weeks, alongside their usual pain management. The Shiatsu therapy will be provided by trained practitioners following a standardized approach developed for this study. This single-arm prospective trial does not include a comparison group but monitors changes throughout the treatment and follow-up periods. During the study, participants will complete questionnaires about their quality of life and the impact on their family before starting treatment, midway through, at the end of the six-week therapy, and again three months later. Researchers will also measure pain intensity using a numerical rating scale at these same time points. The study includes regular assessments to track changes and monitor safety while participants continue with their usual care.

CONDITIONS

Brief Title

Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents

Who Can Participate

Age: 10Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents aged 10 to 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 if parents are separated)
  • Participants aged 16 years or older must also sign informed consent
Not Eligible

You will not qualify if you...

  • Informed consent cannot be obtained from the participant or their legal guardians
  • Legal guardians unable to provide informed consent
  • Patients with severe conditions such as 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 6 weeks

Participants receive one 30-minute session of Shiatsu therapy per week for 6 weeks, in addition to their usual pain management.

Weekly visits for 6 weeks

Follow-up

Duration - 12 weeks

Participants are monitored for changes in quality of life and pain intensity for 3 months after the last Shiatsu therapy session.

1 visit at 3 months post-intervention

Trial Site Locations

Total: 2 locations

1

Tel Aviv Univrsity

Tel Aviv, Tel Aviv, Israel

Not Yet Recruiting

2

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

Tel Aviv, Israel, 64239-06

Actively Recruiting

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Research Team

E

Eyal Cohen-Sela, MD

M

Merav Heshin-Bekenstein, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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