Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415747
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2024-05-10
Brief Title:
Early Pain Finding in Infants With Brachial Plexus Birth Injury
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Early Pain Finding in Infants With Brachial Plexus Birth Injury
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Brachail Plexus Birth Palsy BPBI fractures glenohumeral joint dislocation torticollis and plagiocephaly facial nerve palsy phrenic nerve palsy obesity speech delay integumentary system problems and central nervous system disorders are common comorbidities Clinical assessments such as observation palpation and radiologic imaging are commonly used to identify early period comorbidities after delivery Since fractures or joint deformities may occur in the affected upper extremity due to high-energy trauma at birth pain assessment in the early postnatal period is recommended and several objective assessment methods have been proposed Due to the difficulty of pain assessment in early childhood the assessment is mostly performed by palpation Pain is suspected if the baby grimaces with light palpation of the neck and upper shoulder area
Although some hospitals have adopted objective assessment of pain and objective assessment is recommended the level of pain in early childhood has not been investigated Therefore the aim of our study was to determine the level of pain in BPBI in early childhood and to examine the relationship between pain and motor function In addition the second aim of the study is to determine the cut-off value of the pain level that may be a sign of fracture in patients with BPBI in order to suspect a fracture in the shoulder region and request additional examinations
The diagnosis of BPBI determination of Narakas classification and evaluation of comorbidities were performed by a senior orthopedic surgeon After the initial doctors examination patients are routinely referred to the physiotherapy clinic for a physiotherapy evaluationIn the assessment active joint movement and pain assessments of children were used and all of these assessments were performed by a hand and pediatric physiotherapist
Although some hospitals have adopted objective assessment of pain and objective assessment is recommended the level of pain in early childhood has not been investigated Therefore the aim of our study was to determine the level of pain in BPBI in early childhood and to examine the relationship between pain and motor function In addition the second aim of the study is to determine the cut-off value of the pain level that may be a sign of fracture in patients with BPBI in order to suspect a fracture in the shoulder region and request additional examinations
The diagnosis of BPBI determination of Narakas classification and evaluation of comorbidities were performed by a senior orthopedic surgeon After the initial doctors examination patients are routinely referred to the physiotherapy clinic for a physiotherapy evaluationIn the assessment active joint movement and pain assessments of children were used and all of these assessments were performed by a hand and pediatric physiotherapist
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None