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NCT Number: NCT06929598

Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents

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.

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Key information

Conditions

Chronic Pain Agnosia Chronic Pain Syndrome Chronic Pain and Comorbid Emotional Problems Chronic Pain, Psychogenic Chronic Pain, Widespread Fibromyalgia Fibromyalgia Syndrome Functional Pain Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv Univrsity, Tel Aviv, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shiatsu Therapy

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eyal Cohen-Sela, MD

CONTACT

[email protected]

+972-3-6974247

Merav Heshin-Bekenstein, MD

CONTACT

[email protected]

+972-3-6974247

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ShiQoL

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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