Clinical Trials Directory

Trials / Completed

CompletedNCT06415747

Early Pain Finding in Infants With Brachial Plexus Birth Injury

Status
Completed
Phase
Study type
Observational
Enrollment
59 (actual)
Sponsor
Hacettepe University · Academic / Other
Sex
All
Age
15 Days – 90 Days
Healthy volunteers
Not accepted

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 doctor's examination, patients are routinely referred to the physiotherapy clinic for a physiotherapy evaluation.In 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.

Conditions

Interventions

TypeNameDescription
OTHERObservational pain and motor function assessments, and also comorbidities assessments with x-ray.There was no intervention in our study, only observational and quantitative clinical evaluations.

Timeline

Start date
2021-01-01
Primary completion
2023-06-01
Completion
2023-06-01
First posted
2024-05-16
Last updated
2024-05-17

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06415747. Inclusion in this directory is not an endorsement.