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

NCT05013619 | Completed

• 1 other identifier: 20
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Gross Motor Functional Classification System level

  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 .

  Through study completion, an average of 1 month

• Pain distribution

  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)

  Through study completion, an average of 1 month

• The 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.

  Through study completion, an average of 1 month

Study Arms (2)

adolescent cerebral palsy

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

Other: Circumstances of pain; Other: Pain Questionnaire; Other: Gross Motor Functional Classification System; Other: The subtypes of Cerebral palsy

adolescent cerebral palsy's mother

pain questionnaire will be analyzed.

Other: Pain Questionnaire

Interventions

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.

adolescent cerebral palsy

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.

adolescent cerebral palsy; adolescent cerebral palsy's mother

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

adolescent cerebral palsy

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

adolescent cerebral palsy

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

adolescent cerebraly palsy and their mothers

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Fatma Özcan, MD

  Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 19, 2021
• Study Start: July 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)