The Efficacy of Adjunctive Shiatsu Therapy for Non-Inflammatory Chronic Pain in Pediatric Patients: A Single-Arm Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scale Total Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scale Total Score
时间窗: 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)
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.
次要结局
- Change in Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM) Total Score(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)(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))
研究者
Eyal Cohen-Sela
Medical Doctor
Tel Aviv University