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Paediatric chronic pain clinic cohort

Paediatric Chronic pain Clinic LOngitudinal cohort (PiCCoLO) study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14246648
Enrollment
1000
Registered
2024-06-06
Start date
2024-11-01
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

Paediatric chronic pain patients Musculoskeletal Diseases

Interventions

The study aims to describe and quantify the type and impact of chronic pain in CYP, and the degree and duration of change throughout usual care. It is routine practice at Great Ormond Street Hospital
ii) inform a biopsychosocial formulation and management plan
and iii) collection at subsequent appointments facilitates monitoring of treatment response. The research team will prospectively collect clinical data, PROMs scores, and information regarding inte

Sponsors

Great Ormond Street Hospital for Children NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years

Inclusion criteria

Inclusion criteria: 8 - 18 years old, referred to the GOSH chronic pain service

Exclusion criteria

Exclusion criteria: 1. Unwilling/unable to provide written informed Participant consent/assent and Parental consent 2. Outside of the stated age range (8 - 18 years). 3. If the parent/carer is unable to understand English, consent will be obtained only if a suitable interpreter can be sourced in line with usual clinical care. Children and Young People (CYP) who are unable to speak English or who are only managing school at a level less than usual for an 8-year old will be excluded as current versions of PROMs on EPIC are not available in multiple languages.

Design outcomes

Primary

MeasureTime frame
Overall well-being (quality of life) measured using the Paediatric Quality of Life Inventory (PedsQL Core Domains V4, total score, Child Versions (ages) & Parent version) at each clinic visit, and at 3 and 5 years post referral for participants consenting to longer follow-up.

Secondary

MeasureTime frame
Collected from each clinic visit, and extend outcome reporting to 3 and 5 years post referral for participants consenting to longer-term follow-up: 1. Pain intensity (using a 1-10 visual analogue scale [VAS]) (now, average last week, worst last week) 2. Pain interference with daily living measured using the Paediatric PROMIS Pain Interference Short Form 8a 3. Physical function measured using the Physical function subscale of PedsQL (Child and Parent/Caregiver on behalf of child); physiotherapist assessment of muscle strength (MMT) 4. Psychosocial and family function measured using Emotional and Social domains of PedsQL (Child version & Parent/caregiver version relating to child) 5. Pain catastrophising measured using Pain Catastrophising Scale (PCS; child version and parent/caregiver version) 6. Child mental health measured using the Paediatric Index of Emotional Distress (PI-ED) 7. Parent/caregiver mental health measured using the Hospital Anxiety and Depression Scale (HADS) 8. School function/attendance measured using the school subscale of PedsQL, attendance reported at routine Pain Clinic appointments by child/parent and by the school (if latter available) 9. Pain-related disability measured using above-mentioned questionnaires, which form an overall view of pain-related disability 10. A case-report form (CRF), completed using patient notes collected onto EPIC following first assessment at Pain Clinic appointments, will capture: 10.1. demographics (age, sex, diagnosis) 10.2. pain: classification, distribution and duration of pain at primary site, pain at additional sites, spread, aggravating/relieving factors 10.3. medical history (current/prior illness, surgery, previous investigations) 10.4. details of pharmacological and multidisciplinary management methods, past and planned 11. For those who consent to follow-up at 3 and 5 years post referral, a follow-up CRF will collect directly from participants regarding: 11.1. Pain: classification, distribution and dura

Countries

England, United Kingdom

Contacts

Public ContactAnna Fieldwalker
anna.fieldwalker@gosh.nhs.uk+44 20 7813 8268

Outcome results

None listed

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