Menu
Recruiting NCT06929598

Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents

No phase Interventional Chronic Pain Chronic Pain Syndrome Chronic Pain and Comorbid Emotional Problems Chronic Pain, Psychogenic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shiatsu Therapy.
Who it may be relevant to
Registry conditions: Chronic Pain, Chronic Pain Syndrome, Chronic Pain and Comorbid Emotional Problems, Chronic Pain, Psychogenic. Basic parameters: 10 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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)]
Secondary outcome measures (2)
  • 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)]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Israel · 2 centers
  • Tel Aviv Univrsity — Tel Aviv
  • Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center — Tel Aviv

Identifiers

NCT: NCT06929598 · 0661-2222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗