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Completed

NCT Number: NCT04883489

Pain Classification in Caregivers for Children With Cerebral Palsy

The care of children with Cerebral Palsy is a process that continues for many years. Individuals who take care of them experience musculoskeletal pain due to the difficulties they experience and face pain that becomes chronic over time. For individuals who take care of children with CP, determining the types of chronic pain is important in order to clarify the classification criteria and for individuals to reach better living standards by tailoring the treatments they will receive. Therefore, the aim of the study is to determine the types of chronic pain in caregivers for children with cerebral palsy.

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Key information

Conditions

Chronic Pain Brain Damage, Chronic Brain Diseases Caregivers Central Nervous System Diseases Cerebral Palsy Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

KutahyaHSU

Kütahya, 43000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Having musculoskeletal pain complaints for the last 6 months or more
  • experienced musculoskeletal pain or a sensitive disorder (like numbness, tingling, etc.) anywhere in body for which they stated a minimum score of 2 on a numeric pain rating scale
  • pain that lasts at least 6 months
  • To provide the documented diagnosis of Cerebral palsy of the child in the care of the participants.

Exclusion criteria

  • Having severe psychological illness
  • Having a cognitive dysfunction
  • Not participating in the assessment or submitting incomplete answers for questionnaires

Treatment and study plan

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 1 minute

    The NPRS was used to assess the participants' pain levels. In the NPRS, patients are asked to verbally rate the severity of their pain on a scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  2. Margolis Pain Diagram

    Time frame: 5 minute

    The Margolis Pain Diagram, consists of a dorsal and a ventral drawing body, is used to assess the location and distribution of the pain. Participants will ask to point out the place where they experience pain during the preceding 4 weeks for at least 24 hours

  3. Central Sensitization Inventory

    Time frame: 10 minute

    The Central Sensitization Inventory (CSI) aims to evaluate symptoms thought to be associated with nociplastic pain. The CSI consists 25 items exploring emotional and somatic disorders associated with CS. Each response is scored from 0 to 4, yielding a total score of 0 to 100. A score of 40 or higher on the CSI means the presence of nociplastic pain.

  4. Short Form 36

    Time frame: 10 minute

    The Short Form-36 (SF-36) is widely used to measurement of health related quality of life (HRQoL) questionnaire. SF-36 is a 36-item generic self-administered instrument consisting of 8 subscales related to various aspects of HRQoL: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The 8 subscales are scored from 0 to 100, with higher scores indicating better health status.

Secondary outcomes

  1. Quantitative sensory test

    Time frame: 10 minute

    Quantitative sensory testing (QST) is a psychophysical method used to quantify somatosensory function in patients. In QST will be used various stimuli static thermal (thermotest), static mechanical ( a painter brush), pinprick (a calibrated pin) and vibration ( a tuning folk). QST will interrogate whether each stimulus is considered a sensory loss (negative sign) or sensory gain (positive sign or hyperalgesia).

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Clinical Classification of Musculoskeletal Pain in Caregivers for Children With Cerebral Palsy

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 12, 2021
Registry last updated
Apr 10, 2023

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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