Clinical trial NCT06798233: Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire
Official title: Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Quadriplegia/Tetraplegia
Keywords: hip pain
pain measurements
children
adolescents
cerebral palsy
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
Collaborators: name: IRCCS Fondazione Stella Maris
First posted: 2025-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study includes the following steps:

* development of the questionnaire to identify hip pain by means of a Delphi Method approach, involving a group of experts (clinicians and caregivers)
* validation of the questionnaire by administering it to 100 caregivers of quadriplegic non-communicative patients
* comparing results of the questionnaire with r-FLACC scale filled out by the physiatrist moving the hip during the visit
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is twofold:

1. to develop a questionnaire for care givers to assess hip pain in quadriplegic pediatric patients who are not able to communicate it independently
2. to validate this questionnaire in a cohort of 100 pediatric patients with quadriplegia

Researchers will :

1. involve 10 experts (8 multiprofessional clinicians and 2 parents) in a Delphi approach to develop the questionnaire
2. assess construct validity and reliability of the questionnaire submitting it to 100 care givers of pediatric patients with quadriplegia, and comparing results with the Revised Face Legs Activity Cry and Consolability (r-FLACC) Scale assessed by the physiatrist during the visit

Participants will:

1. as experts, firstly answer open questions on this topic, secondly evaluate each item of the new questionnaire by means of a 5-point Liekert scale
2. as caregivers of pediatric patients with quadriplegia, fill out the questionnaire within 2 weeks after the visit

Detailed description: Patients with quadriplegia have complex health and care needs: multimorbidity increases mortality, worsens functioning and participation (according to the ICF model) and negatively affects quality of life. One of the main problems that is difficult to identify early is undoubtedly pain, complicated by the many potential sources of pain and the different levels of intellectual and communicative disability of these patients. Although pain is a frequent concern for these patients and their families, as it greatly interferes with the daily activities and quality of life of all members of the household, it is very often underestimated, consequently little treated and little studied. In the pediatric population, the majority of patients with these characteristics have a diagnosis of Cerebral Palsy (CP): 26% have quadriplegia, classifiable as level IV-V of the Gross Motor Function Classification System (GMFCS). In children with CP, pain is a secondary problem to primary disorders, but with a strongly negative impact on the overall picture, both for the strictly clinical aspects and for the deterioration of quality of life. More than 90% of children with CP between 5 and 18 years of age report experiences of pain within the 1st year (48% ambulatory patients, 79% non-ambulatory patients). A previous study on a sample of 101 parents of children with nonverbal CP, between 2 and 20 years old, report that 65% reported painful experiences in the last 4 weeks (for 17% the pain is intense, for 28% it is daily). Among the most common causes of chronic pain is described pain of musculoskeletal origin, often caused by joint misalignments, increased muscle tone and osteoporosis. Hip dislocation and associated pain are certainly among the main topics of rehabilitation relevance. According to literature data, the specific prevalence of hip pain ranges from 9.6% to 27% in non-ambulatory children or adolescents with CP. Hip pain increases with age, GMFCS level, and degree of dislocation. To monitor and detect hip migration early, as well as to prevent pain, several countries have developed specific hip surveillance programs for children with CP. Population-based registry studies have reported a prevalence of hip pain of 7.9% in patients with IV GMFCS and 20.5% among patients with IV GMFCS in the 4-16 age group, and an overall prevalence of 72% among adolescents and young adults with PC. The highest prevalence of hip pain is found in patients over 11 years of age. In non-verbal children or children with limited verbal and cognitive abilities, the description of pain is entrusted to parents and/or caregivers (observational/proxy methods), who know and interpret the typical behavioral response of their child. Therefore, in addition to a detailed medical history and physical examination, the importance of recognizing painful behaviors and the use of pain hetero-assessment scales was highlighted. According to a recent systematic review the parent or caregiver report can be used as an alternative for pain assessment in children with or at high risk of CP. The NICE guidelines for the identification of pain and the assessment of its intensity in children and adolescents with communication difficulties suggest the use of the Paediatric Pain Profile (PPP) or the Non-communicating Children's Pain Checklist - postoperative version (NCCPC-R). However, none of these tools are specific to CP patients. In 2004 the Pain Assessment Instrument for Cerebral Palsy (PAICP) was presented, a questionnaire dedicated to patients with severe CP, which uses Alternative Augmentative Communication images to identify potentially painful situations associated with the Faces Pain Scale to identify pain intensity. This tool, however, is not specific for hip pain and, moreover, implies a sufficient cognitive level to use the aforementioned communication tools. Based on our knowledge, there are no new studies that point to specific and/or effective tools for the identification of hip pain in quadriplegic pediatric patients. Therefore, to date, there is no specific assessment tool available for this population that investigates the presence and characteristics of hip pain. The aim of the present study is to develop and validate a questionnaire to be administered to caregivers, that can assist healthcare professionals in the identification of hip pain in pediatric patients with quadriplegia.

Eligibility criteria: Inclusion Criteria:

* GMFCS IV-V
* CFCS III-V
* subscription of consent

Exclusion Criteria:

* care givers not speaking Italian or English

Primary outcomes:
measure: Content validity of the Non-Ambulatory Hip Pain questionnaire (NAHPq)
timeFrame: The NAHPq is filled out by the caregiver within 2 weeks after the recruitment visit, during which the hip pain is assessed by the physiatrist with the r-FLACC scale.
measure: Internal reliability of the Non-Ambulatory Hip Pain questionnaire (NAHPq)
timeFrame: The NAHPq is filled out by the caregiver within 2 weeks after the recruitment visit, during which the hip pain is assessed by the physiatrist with the r-FLACC scale.
Secondary outcomes:
measure: Criterion validity of the Non-Ambulatory Hip Pain questionnaire (NAHPq)
timeFrame: The hip pain will be assessed by the physiatrist with the r-FLACC scale during the visit; by the care giver with the NAHPq within 2 weeks after the visit.
Other outcomes:
Locations:
city: Spilamberto
country: Italy
facility: AziendaUSL IRCCS Reggio Emilia
state: Modena
city: Pisa
country: Italy
facility: IRCCS Fondazione Stella Maris
Study officials:
References:
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