Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents

NCT06929598 | Recruiting

• 1 other identifier: 0661-2222
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Shiatsu; Complementary and Integrative Medicine; Pediatric Chronic Pain; Non-inflammatory Pain; Quality of Life; PedsQL; Adolescent Pain; Manual Therapy; Mind-Body Therapy; Pediatric Rheumatology; Integrative Medicine; Functional Pain; Pain Management

Outcome Measures

Primary Outcomes (1)

• Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scale Total Score

  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 Outcomes (2)

• 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)

• 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)

Study Arms (1)

Shiatsu Therapy Group

EXPERIMENTAL

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

Interventions

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.

Shiatsu Therapy Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel Aviv University: lead
• Tel Aviv Sourasky Medical Center, Tel Aviv, Israel: collaborator
• Dana-Dwek Children's Hospital: collaborator

Study Sites (2)

Tel Aviv Univrsity

Tel Aviv, Tel Aviv, Israel

NOT YET RECRUITING

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

Tel Aviv, 64239-06, Israel

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia; Agnosia

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Merav Heshin-Bekenstein, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyal Cohen-Sela, MD

CONTACT

+972-3-6974247; cohensela@mail.tau.ac.il

Merav Heshin-Bekenstein, MD

CONTACT

+972-3-6974247; prheum@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 16, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

IL (2)