Actively Recruiting
The Efficacy of Adjunctive Shiatsu Therapy for Non-Inflammatory Chronic Pain in Pediatric Patients: A Single-Arm Prospective Trial
Led by Tel Aviv University · Updated on 2025-09-04
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tel Aviv University
Lead Sponsor
T
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding Shiatsu therapy to standard treatment can improve the quality of life in children and adolescents aged 10 to 18 years who have chronic pain that is not caused by inflammation. The study focuses on understanding if weekly Shiatsu sessions can help those with long-lasting pain conditions such as fibromyalgia and functional pain. About 40 participants who are already being treated at pediatric pain and rheumatology clinics will take part in this trial. Participants will receive one 30-minute Shiatsu therapy session each week for six weeks, alongside their usual pain management. The Shiatsu therapy will be provided by trained practitioners following a standardized approach developed for this study. This single-arm prospective trial does not include a comparison group but monitors changes throughout the treatment and follow-up periods. During the study, participants will complete questionnaires about their quality of life and the impact on their family before starting treatment, midway through, at the end of the six-week therapy, and again three months later. Researchers will also measure pain intensity using a numerical rating scale at these same time points. The study includes regular assessments to track changes and monitor safety while participants continue with their usual care.
CONDITIONS
Brief Title
Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 10 to 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 if parents are separated)
- Participants aged 16 years or older must also sign informed consent
You will not qualify if you...
- Informed consent cannot be obtained from the participant or their legal guardians
- Legal guardians unable to provide informed consent
- Patients with severe conditions such as 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive one 30-minute session of Shiatsu therapy per week for 6 weeks, in addition to their usual pain management.
Weekly visits for 6 weeks
Duration - 12 weeks
Participants are monitored for changes in quality of life and pain intensity for 3 months after the last Shiatsu therapy session.
1 visit at 3 months post-intervention
Trial Site Locations
Total: 2 locations
1
Tel Aviv Univrsity
Tel Aviv, Tel Aviv, Israel
Not Yet Recruiting
2
Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239-06
Actively Recruiting
Research Team
E
Eyal Cohen-Sela, MD
M
Merav Heshin-Bekenstein, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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