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

NCT ID: NCT05013619

Last Updated: 2021-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2021-10-01

Brief Summary

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.

Detailed Description

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; adolescent; pain; parent report; self report

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

adolescent cerebral palsy

Demographical data, the subtypes of CP, Gross Motor Functional Classification System level, circumstances of pain, pain questionnaire will be analyzed.

Circumstances of pain

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

adolescent cerebral palsy's mother

pain questionnaire will be analyzed.

Pain Questionnaire

Intervention Type: 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.

Interventions

Circumstances of pain

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.

Intervention Type: OTHER

Pain Questionnaire

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.

Intervention Type: OTHER

Gross Motor Functional Classification System

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

Intervention Type: OTHER

The subtypes of Cerebral palsy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

• 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

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yasin Demir

Physical Medicine and Rehabilitation Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma Özcan, MD

Role: PRINCIPAL_INVESTIGATOR

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Locations

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

20

Identifier Type: -

Identifier Source: org_study_id