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Feasibility of a new paediatric pain rehabilitation programme

PIIPeR Trial: Impact of Paediatric Intensive Interdisciplinary Pain Rehabilitation for children with chronic pain and pain-related disability: Feasibility of recruitment to a randomised trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN91641999
Enrollment
48
Registered
2024-08-12
Start date
2024-08-20
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pain in young people aged 11-18 years old Signs and Symptoms

Interventions

This is a single-site randomized within-cohort feasibility study (interventional) with 2 years duration. Following referral and usual interdisciplinary assessment at Great Ormond Street Hospital Chron

Sponsors

Great Ormond Street Hospital for Children NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
11 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. CYP aged 11-18 years with chronic pain (>3 months duration) following referral to, and multidisciplinary assessment at, the GOSH Chronic Pain Clinic. Eligibility will not be influenced by biological sex, gender, ethnicity, or socioeconomic grouping. 2. Willing and able to provide written informed Participant consent/assent and Parental consent 3. Fulfil at least 3 of the 4 criteria: 3.1. Significant pain-related disability (PedsQL quality of life total score 20) 3.3. School attendance 20) and/or physical (specialist physiotherapy assessment of reduction in mobility and muscle strength) comorbidity

Exclusion criteria

Exclusion criteria: 1. Unwilling/unable to provide written informed Participant consent/assent and/or Parental consent 2. Non-engagement and/or not willing to accept biopsychosocial formulation and management plan 3. Major psychological or psychiatric illness (personality disorder, severe depression, eating disorder) that requires specific therapy 4. Other acute intercurrent illness/infection that precludes involvement in group activities or ability to attend full-time Participant Timetable 5. Parent/carer unable to attend for joint and parallel Parent Timetable 6. Severe limitation of mobility due to an intercurrent medical condition that precludes involvement in group activities (based on the clinical history and medical and physiotherapy assessment) 7. Any primary psychological disorder likely to interfere with engagement with the intervention including, but not limited to: externalising conduct disorder, chronic fatigue syndrome, functional neurological disorder, and eating disorders (based on clinical psychology assessment at Chronic Pain Clinic and by PPRP clinical staff). 8. Significant limitations in understanding written and verbal English that would preclude the participant's engagement in group activities and verbal discussions. As patients referred to GOSH Pain Clinic are usually attending UK schools, this exclusion would be rare. Parental language barriers are relative exclusion criteria. In line with current clinical practice, information for parents and consent can be obtained with interpreters, and some educational material can be translated from English. The extent to which parental understanding of verbal English would limit engagement in parent sessions and skills training would be assessed on an individual basis.

Design outcomes

Primary

MeasureTime frame
Current primary outcomes as of 16/12/2025: 1. Recruitment rate: number of CYPs referred to GOSH Pain Service who fulfil eligibility criteria consenting to enter the study measured using the screening and recruitment logs at Day 1 PPRP 2. Time-frame adherence: proportion of enrolled participants for whom it was feasible to enter the PPRP within the designated time-frame (1-3 months for Early, 6-9 months for Delayed) 3. Treatment completion rate, defined as the proportion of enrolled participants completing the 3-week PPRP, measured using the study Attendance Log on Day 19 PPRP (immediate post-intervention) 4. Follow-up rate, defined as the proportion of enrolled participants who “attend” the online 3 months and 6 months post-PPRP assessments, measured using the study Attendance Log at 3 and 6 months post-PPRP Previous primary outcomes: 1. Recruitment rate: number of CYPs referred to GOSH Pain Service who fulfil eligibility criteria consenting to enter the study measured using the screening and recruitment logs at Day 1 PPRP 2. Treatment completion rate, defined as the proportion of enrolled participants completing the 3-week PPRP, measured using the study Attendance Log on Day 19 PPRP (immediate post-intervention) 3. Follow-up rate, defined as the proportion of enrolled participants who “attend” the online 3 months and 6 months post-PPRP assessments, measured using the study Attendance Log at 3 and 6 months post-PPRP

Secondary

MeasureTime frame
Current secondary outcomes as of 16/12/2025: Intervention: 1. The number of deviations by PPRP clinical staff from program timetable and/or content (with reasons recorded and potential contributing/mitigating factors) and number of essential elements delivered ('dose delivered') measured using study records at one timepoint; attendance by participant and parent/carer throughout 3-week PPRP ('dose received'). 2. The acceptability of study design, by the participant, parent/carer, clinical care team, and PPRP staff, measured using qualitative interview on Day 1 of the PPRP and at the 3-month follow-up 3. Participant and parent-reported satisfaction, measured using at Treatment Satisfaction Scale (NRS 0-10), measured on Day 19 (i.e., final day) of the PPRP and the 3-month follow-up 4. The identification and reporting of adverse events, measured using official reports as detailed in the protocol at one timepoint Data Collection: 1. The proportion of complete datasets: Case Report Form, PROMs and questionnaires, and physical assessments, measured by calculating the number of complete datasets versus the number of incomplete datasets, measured on Day 1 and Day 19 of PPRP, and at 3 months and 6 months post-PPRP 2. The feasibility of calculating health and social care resource use and wider societal impact including days off school, measured using the Child and Adolescent Service Use Schedule (CA-SUS) on Day 1 of PPRP and at the 6-month post-PPRP follow-up. 3. The feasibility of calculating quality-adjusted life years measured using the Child Health Utility instrument 9 Dimensions (CHU-9D) on Day 1 of the PPRP and at 6-months post-PPRP Previous secondary outcomes: Intervention: 1. The number of deviations by PPRP clinical staff from program timetable and/or content (with reasons recorded and potential contributing/mitigating factors) and number of essential elements delivered ('dose delivered') measured using study records at one timepoint 2. The acceptability of study de

Countries

England, United Kingdom

Contacts

Public ContactSuellen;Anna Walker;Fieldwalker

;

suellen.walker@gosh.nhs.uk;anna.fieldwalker@gosh.nhs.uk+44 (0)2078138268;+44 (0)2078138268

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026