Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents (NCT06929598) | Clinical Trial Compass
RecruitingNot Applicable
Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents
Israel40 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range
10 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)