Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents (ShiQoL)

August 27, 2025 updated by: Eyal Cohen-Sela, Tel Aviv University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239-06
        • Recruiting
        • Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center
        • Contact:
    • Tel Aviv
      • Tel Aviv, Tel Aviv, Israel
        • Not yet recruiting
        • Tel Aviv Univrsity
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scale Total Score
Time Frame: Baseline (Day 0), Week 3 (after the 3rd Shiatsu session), Week 6 (after the 6th Shiatsu session, end of intervention), and Week 18 (3 months post-intervention)
The PedsQL 4.0 Generic Core Scale is a validated questionnaire that measures health-related quality of life in children and adolescents. Participants will complete the age-appropriate version of the PedsQL. It includes 23 items across four subscales: physical, emotional, social, and school functioning. Responses are reverse-scored and transformed to a 0-100 scale. Higher scores indicate better quality of life. The change in total score from baseline to follow-up time points will be assessed.
Baseline (Day 0), Week 3 (after the 3rd Shiatsu session), Week 6 (after the 6th Shiatsu session, end of intervention), and Week 18 (3 months post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM) Total Score
Time Frame: Baseline (Day 0), Week 3 (after the 3rd Shiatsu session), Week 6 (after the 6th Shiatsu session, end of intervention), and Week 18 (3 months post-intervention)
The Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM) is a validated caregiver-reported questionnaire that assesses the impact of a child's health condition on family functioning. It includes 36 items covering physical, emotional, social, and cognitive functioning, communication, worry, daily activities, and family relationships. Responses are reverse-scored and transformed to a 0-100 scale. Higher scores indicate better family functioning and less caregiver burden. The change in total score from baseline to follow-up time points will be assessed.
Baseline (Day 0), Week 3 (after the 3rd Shiatsu session), Week 6 (after the 6th Shiatsu session, end of intervention), and Week 18 (3 months post-intervention)
Change in Pain Intensity (Numerical Rating Scale, NRS)
Time Frame: Baseline (Day 0), Week 3 (after the 3rd Shiatsu session), Week 6 (after the 6th Shiatsu session, end of intervention), and Week 18 (3 months post-intervention)
Pain intensity will be self-reported using the Numerical Rating Scale (NRS), a validated 11-point scale ranging from 0 to 10, where 0 means "no pain" and 10 means "worst possible pain." Participants will rate their pain at each time point. The change in score from baseline to follow-up time points will be assessed.
Baseline (Day 0), Week 3 (after the 3rd Shiatsu session), Week 6 (after the 6th Shiatsu session, end of intervention), and Week 18 (3 months post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel Aviv University

Collaborators

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

Investigators

  • Principal Investigator: Merav Heshin-Bekenstein, MD, Dana Dwek Children's Hospital, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 7, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0661-2222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The research team has not yet finalized a plan for sharing individual participant data (IPD). Data sharing options will be considered in accordance with institutional board review, policies, ethical guidelines in our institution, ethical guidelines for pediatric research, and data privacy regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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