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.
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)
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
Single group
Shiatsu Therapy
BehavioralParticipants 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.
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.
Change in Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM) Total Score
The Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM) is a validated caregiver-reported questionnaire that assesses the impact of a child's health condition on family functioning. It includes 36 items covering physical, emotional, social, and cognitive functioning, communication, worry, daily activities, and family relationships. Responses are reverse-scored and transformed to a 0-100 scale. Higher scores indicate better family functioning and less caregiver burden. The change in total score from baseline to follow-up time points will be assessed.
Change in Pain Intensity (Numerical Rating Scale, NRS)
Pain intensity will be self-reported using the Numerical Rating Scale (NRS), a validated 11-point scale ranging from 0 to 10, where 0 means "no pain" and 10 means "worst possible pain." Participants will rate their pain at each time point. The change in score from baseline to follow-up time points will be assessed.
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Tel Aviv University
Lead sponsor
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
Collaborator
Dana-Dwek Children's Hospital
Collaborator
