Clinical trial NCT06929598: Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents
Official title: The Efficacy of Adjunctive Shiatsu Therapy for Non-Inflammatory Chronic Pain in Pediatric Patients: A Single-Arm Prospective Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
name: Dana-Dwek Children's Hospital
First posted: 2025-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scale Total Score
timeFrame: 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:
measure: Change in Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM) Total Score
timeFrame: 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)
measure: Change in Pain Intensity (Numerical Rating Scale, NRS)
timeFrame: 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)
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Univrsity
city: תל אביב
country: Israel
facility: Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Dana Dwek Children's Hospital, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel
name: Merav Heshin-Bekenstein, MD
role: PRINCIPAL_INVESTIGATOR
References: