Pain Classification in Caregivers for Children With Cerebral Palsy

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04883489
• Other study ID #: KutahyaHSU pain in caregivers
• Status: Completed
• Start date: May 15, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2023
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Caregivers
• Cerebral Palsy
• Chronic Pain
• Musculoskeletal Pain

Locations

Country	Name	City	State
Turkey	KutahyaHSU	Kutahya

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale	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).	1 minute
Primary	Margolis Pain Diagram	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	5 minute
Primary	Central Sensitization Inventory	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.	10 minute
Primary	Short Form 36	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.	10 minute
Secondary	Quantitative sensory test	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).	10 minute