Chronic PainShiQoLNCT06929598
Shiatsu for Chronic Non-Inflammatory Pain in Children and Adolescents
A study testing Shiatsu Therapy in people with Chronic Pain and Chronic Pain Syndrome, run by Tel Aviv University at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Chronic Pain, Chronic Pain Syndrome, Chronic Pain and Comorbid Emotional Problems
- What is being tested?
- Shiatsu Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 May 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Not yet recruiting
Tel Aviv Univrsity
Tel Aviv, Tel Aviv
Research Authority Research Authority, 972-3-6406250, Ganitv@tauex.tau.ac.il
- Recruiting
Dana-Dwek Children's Hospital, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239-06
Pediatric Rheumatology Unit, 972-3-6974247, prheum@tlvmc.gov.il
About this study
Official title: The Efficacy of Adjunctive Shiatsu Therapy for Non-Inflammatory Chronic Pain in Pediatric Patients: A Single-Arm Prospective Trial
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:
Read more
- 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.
- Conditions
- Chronic Pain, Chronic Pain Syndrome, Chronic Pain and Comorbid Emotional Problems, Chronic Pain, Psychogenic, Chronic Pain, Widespread, Fibromyalgia
- Being tested
- Shiatsu Therapy
- Keywords
- Shiatsu, Complementary and Integrative Medicine, Pediatric Chronic Pain, Non-inflammatory Pain, Quality of Life, PedsQL, Adolescent Pain, Manual Therapy, Mind-Body Therapy, Pediatric Rheumatology, Integrative Medicine, Functional Pain, Pain Management
- Medical subject headings
- Chronic Pain, Fibromyalgia, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shiatsu TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Shiatsu Therapy Group | Experimental | 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. Receives: Behavioral: Shiatsu Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Secondary outcomes (2)
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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 May 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, prospective study evaluating the effects of adjunctive Shiatsu therapy on quality of life in children and adolescents with non-inflammatory chronic pain. All participants receive the same intervention without a comparison or control group.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Dana-Dwek Children's Hospital
- Responsible party
- Principal investigator, Eyal Cohen-Sela, Tel Aviv University
- Investigators
- Merav Heshin-Bekenstein, MD, Principal investigator, Dana Dwek Children's Hospital, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929598
- Sponsor's protocol ID
- 0661-2222
- Acronym
- ShiQoL
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Adjunctive Shiatsu Therapy for Non-Inflammatory Chronic Pain in Pediatric Patients: A Single-Arm Prospective Trial
- ClinicalTrials.gov ID
- NCT06929598
- Acronym / sponsor ID
- ShiQoL / 0661-2222
- Conditions
- Chronic Pain, Chronic Pain Syndrome, Chronic Pain and Comorbid Emotional Problems, Chronic Pain, Psychogenic, Chronic Pain, Widespread, Fibromyalgia
- Keywords
- Shiatsu, Complementary and Integrative Medicine, Pediatric Chronic Pain, Non-inflammatory Pain, Quality of Life, PedsQL, Adolescent Pain, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, Dana-Dwek Children's Hospital
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, prospective study evaluating the effects of adjunctive Shiatsu therapy on quality of life in children and adolescents with non-inflammatory chronic pain. All participants receive the same intervention without a comparison or control group.
| Arm | Type | Receives |
|---|---|---|
| Shiatsu Therapy Group | Experimental | Behavioral: Shiatsu TherapyParticipants 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shiatsu TherapyParticipants 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. | Behavioural | Shiatsu Therapy Group |
Primary outcome
Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scale Total Score
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)
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.
2 secondary outcomes
Change in Pediatric Quality of Life Inventory Family Impact Module (PedsQL FIM) Total Score
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Merav Heshin-Bekenstein, MD principal investigator
Dana Dwek Children's Hospital, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shiatsu Therapy in people with Chronic Pain and Chronic Pain Syndrome, run by Tel Aviv University at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eyal Cohen-Sela, MD (+972-3-6974247, cohensela@mail.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scale Total Score (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.