An interventional study of Shiatsu Therapy in Chronic Pain, Chronic Pain Syndrome and Chronic Pain and Comorbid Emotional Problems, sponsored by Tel Aviv University. Recruiting at 2 sites in Israel. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Tel Aviv University · Not applicable, Interventional, and Treatment
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:
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.
Exclusion Criteria:
Participants will receive 30-minute Shiatsu therapy sessions once a week for 6 weeks, in addition to their usual pain management. The goal is to assess whether Shiatsu improves quality of life in children and adolescents with non-inflammatory chronic pain.
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.
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.
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 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.
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)
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.
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)
Plan to share: Undecided — The research team has not yet finalized a plan for sharing individual participant data (IPD). Data sharing options will be considered in accordance with institutional board review, policies, ethical guidelines in our institution, ethical guidelines for pediatric research, and data privacy regulations.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tel Aviv University