Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Chronic Pain Syndrome; Chronic Pain and Comorbid Emotional Problems; Chronic Pain, Psychogenic; Chronic Pain, Widespread; Fibromyalgia; Fibromyalgia Syndrome; Functional Pain

• Registration Number: NCT06929598
• Lead Sponsor: Tel Aviv University

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-07
• Last Update Submitted: 2025-04-07
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Study Start: 2025-05-01
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scale Total Score	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 Outcome Measures

Name	Time	Method
Change in Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM) Total Score	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.
Change in Pain Intensity (Numerical Rating Scale, NRS)	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.

Trial Locations

Locations (2)

Tel Aviv Univrsity; 🇮🇱 Tel Aviv, Israel

Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center; 🇮🇱 תל אביב, Israel