Chronic Pain In a Greek Population With Cerebral Palsy

NCT04628156 | Unknown

• 1 other identifier: CPChronicPain
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational, cross-sectional study is to effectuate a survey of chronic pain in a population of children, adolescents and adults with various forms of cerebral palsy in an educational and therapeutic setting in Athens, Greece. (Cerebral Palsy Greece-Open Door) Prevalence, intensity and localisation of pain will be associated to factors related to the functional and communicative limitations of the study's participants. The study also examines the agreement rate between different information sources and evaluation levels of chronic pain assessment in cerebral palsy (self-reports, caregiver questionnaires, observational check-lists administered by rehabilitation professionals, clinical evaluations by experts). A further research aim is to identify behavioural markers of chronic pain in individuals with cerebral palsy and a very limited communicative level.

Conditions

Cerebral Palsy

Keywords

Chronic Pain

Outcome Measures

Primary Outcomes (6)

• Self-reported chronic pain (Intensity) -Children

  Score obtained by the administration of the Wong-Baker Faces Pain Rating Scale for children communicating participants .Minimum score:0 (no pain) Maximum score: 10 (pain of extreme intensity).

  Brief standardised procedure not exceding 5 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.

• Self-reported chronic pain (Intensity)- Adults

  Score obtained by the administration of the Faces Pain Scale-Revised (FPS-R) for adult communicating participants. Minimum score:0 (no pain) Maximum score: 10 (pain of extreme intensity).

  Brief standardised procedure not exceding 5 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.

• Self-reported chronic pain (location)

  Location of self reported pain by communicating participants using the codification system of the Body Diagram

  Βrief standardised procedure not exceding 5 minutes. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.

• Chronic pain reported by caregiver (intensity)

  Score at pain intensity rating scale Minimum score 0: no pain Maximum score:10 (extreme pain)

  Data obtained through questionnaire completed by caregiver at the participant's residence. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.

• Chronic pain in children non-communicating participants assessed by proxy (checklist)

  Total score obtained at the NCCPC- R (Non-Communicating Children's Pain Checklist). Minimum score:0 Maximum score: 90 Cut-off score is 7. A score higher than 7 signifies that the observed participant experiences chronic pain.

  2 hour time frame required for completion of assessment procedure. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.

• Chronic pain in adult non-communicating participants assessed by proxy (checklist)

  Total score obtained at the NCAPC (Non-communicating Adult Pain Checklist). Minimum score:0 Maximum score: 54 Cut- off score is 7. A score higher than 7 signifies that the observed participant experiences chronic pain.

  2 hour time frame required for completion of assessment procedure. Administered during the data collection phase, no intervention involved, this is a cross-sectional observation study.

Study Arms (1)

Outpatients in Cerebral Palsy Greece - Open Door

Outpatients with a diagnosis of cerebral palsy

Eligibility Criteria

• Age: 5 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Outpatients in Cerebral Palsy Greece-Open Door, an educational and therapeutic day care center in Athens for adults and children with cerebral palsy.

You may qualify if:

• Outpatients in the setting Cerebral Palsy Greece-Open Door. They all have a diagnosis of cerebral palsy.

You may not qualify if:

• All other subjects with or without a diagnosis of neurodevelopmental disorder.

Sponsors & Collaborators

• Cerebral Palsy Greece - Open Door: lead

Study Sites (1)

Cerebral Palsy Greece- Open Door

Athens, Greece

Location

MeSH Terms

Conditions

Cerebral Palsy; Chronic Pain

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pantelis Stathis, MD PhD

  Cerebral Palsy Greece - Open Door

  STUDY DIRECTOR

Central Study Contacts

Pantelis Kontogiannis, MSc

CONTACT

+306945445730; panteliskontog@gmail.com

Alkis Iraklis Ginatsis, MSc

CONTACT

+306938140548; algin80@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: November 13, 2020
• Study Start: November 16, 2020
• Primary Completion: February 15, 2021
• Study Completion: March 20, 2021
• Last Updated: November 16, 2020

Record last verified: 2020-11

Locations

GR (1)