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Completed

NCT Number: NCT05013619

Pain Prevalence, Distribution, Effect on Activities of Daily Life in Patients With Adolescent Cerebral Palsy

Pain is the most common secondary condition in patients with CP and the most important factor associated with reduced health-related quality of life. Pain in adolescents with CP is reported approximately 50-75%. Despite being a condition that can be seen with such a high prevalence, it is difficult for researchers and clinicians to capture this subjective perception in CP, as the individual may be a small child, may be cognitively impaired, visually impaired, or have communication difficulties. For these reasons, unrecognized pain can have negative effects on quality of life and participation in daily living activities, both as a result of limited mobility resulting from pain itself and fear-driven avoidance of specific activities. Self-report of pain is appropriate for individuals with CP without cognitive impairment. However, depending on the severity of communication impairment, self-report may be limited or even impossible to obtain in individuals with severe CP. In the case of individuals with CP, self-report supplemented with parent report, when possible, is the recommended strategy.

The aims of this study: (i) to explore what is known about the prevalence, location, intensity and the effect of pain on daily lives of adolescents with CP; (ii) to demonstrate the relation between pain, clinical and sociodemographic characteristics; (iii) to compare self-reports of pain with mothers'reports of their child's pain.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

About this study

The investigators will record demographical data including age, gender, height (cm), weight (kg), body mass index (BMI), school type, type of family (core or combined family) of the children and socioeconomic status of the family, mothers' age and educational level. The subtypes of CP will be classified, using the Swedish classification, into spastic (tetraplegia, diplegia and hemiplegia), ataxic, dyskinetic and mixed. Severity of CP will be determined based on the Gross Motor Functional Classification System. It will be questioned in which situations the pain occurred in the previous week (at rest from spasms, at rest from splints, on feeding, on moving, on dressing, at night, on exercise, on other treatments, on botulinum toxin application) and record as yes/no. The pain questionnaire described by Doralp et al (14) will be used both for the self-evaluation of adolescents with CP' pain and for mothers to evaluate their children's pain. Participants will be asked to respond to the initial question "Over the past month, have you experienced physical pain?" (yes or no). Those responding "yes" will be asked "Please indicate how severe your pain was over the past month, on average," with response options from 1 (very little pain) to 10 (extremely painful). They will be asked to indicate "How much the pain gets in the way of your daily activities over the past month" from a low of 1 (does not get in the way at all) to 10 (unable to carry out activities because of the pain). Finally, they will be asked to indicate the body regions in which they experienced pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients:

  • adolescents, aged 8 to 18 years with a diagnosis of cerebral palsy
  • able to understand and answer the questions

Exclusion criteria

for patients:

  • previous interventional procedures, such as surgery within the last one month
  • using painkillers
  • having concomittan diagnosed 'Autism Spectrum Disorder' or 'Attention Deficit Hyperactivity Disorder' or another neuromuscular disorder

Inclusion criteria

for their mothers:

  • primary caregivers who spend most of their time with their children
  • do not work outside the home

Exclusion criteria

for their mothers:

  • not primary caregivers who spend most of their time with their children
  • work outside the home

Treatment and study plan

Circumstances of pain

Other

It will be questioned in which situations the pain occurred in the previous week (at rest from spasms, at rest from splints, on feeding, on moving, on dressing, at night, on exercise, on other treatments, on botulinum toxin application) and record as yes/no.

Pain questionnaire

Other

Participants will be asked to respond to the initial question "Over the past month, have you experienced physical pain?" (yes or no). Those responding "yes" will be asked "Please indicate how severe your pain was over the past month, on average," with response options from 1 (very little pain) to 10 (extremely painful). They will be also asked to indicate "How much the pain gets in the way of your daily activities over the past month" from a low of 1 (does not get in the way at all) to 10 (unable to carry out activities because of the pain). Finally, they will be asked to indicate the body regions in which they experienced pain.

Gross Motor Functional Classification System

Other

Severity of CP will be determined based on the Gross Motor Functional Classification System (GMFCS). GMFCS is a standardised measure that classifies gross motor functions in children with CP. Children in level I are very independent in motor functions while those in level V are the least independent

The subtypes of Cerebral palsy

Other

The subtypes of CP will be classified, using the Swedish classification, into spastic (tetraplegia, diplegia and hemiplegia), ataxic, dyskinetic and mixed

Primary outcomes

  1. Gross Motor Functional Classification System level

    Time frame: Through study completion, an average of 1 month

    GMFCS is a standardised measure that classifies gross motor functions in children with CP. Children in level I are very independent in motor functions while those in level V are the least independent .

  2. Pain distribution

    Time frame: Through study completion, an average of 1 month

    It will be questioned in which situations the pain occurred in the previous week (at rest from spasms, at rest from splints, on feeding, on moving, on dressing, at night, on exercise, on other treatments, on botulinum toxin application)

  3. The pain questionnaire

    Time frame: Through study completion, an average of 1 month

    Participants will be asked to respond to the initial question "Over the past month, have you experienced physical pain?" (yes or no). Those responding "yes" will be asked "Please indicate how severe your pain was over the past month, on average," with response options from 1 (very little pain) to 10 (extremely painful). They will be also asked to indicate "How much the pain gets in the way of your daily activities over the past month" from a low of 1 (does not get in the way at all) to 10 (unable to carry out activities because of the pain). Finally, they will be asked to indicate the body regions in which they experienced pain.

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

Pain Prevalence, Distribution, Effect on Activities of Daily Life in Patients With Adolescent Cerebral Palsy and a Comparion of the Mother-child Report

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2021
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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