Early Pain Finding in Infants With Brachial Plexus Birth Injury

NCT ID: NCT06415747

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-06-01

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 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

Brachial Plexus Palsy

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Brachial Plexus Birth Injury

It was determined that 76 babies with BPBI and their families applied to our hospital for their first medical check or examination. Inclusion criteria: a diagnosis of BPBI, initial evaluation and not having started treatment before, being in the age range of 15-90 days old, and consent to participate in the study. Exclusion criteria: Children with BPBI who are older than 90 days or younger than 15 days and have started regular physical therapy or home program before applying to our hospital. In addition, causes of pseudo-paralysis that are diseases that may show symptoms similar to BPBI were excluded. Seventeen children who were excluded because they did not meet the inclusion criteria. Hence, 59 children with BPBI were included in the study.

Observational pain and motor function assessments, and also comorbidities assessments with x-ray.

Intervention Type: OTHER

There was no intervention in our study, only observational and quantitative clinical evaluations.

Interventions

Observational 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Having diagnosis of Brachial Plexus Birth Injury (BPBI),
• Being initial evaluation and not having started treatment before,
• Being in the age range of 15-90 days old,
• Consent to participate in the study.

Exclusion Criteria

• Children with BPBI who are older than 90 days or younger than 15 days,
• Starting regular physical therapy or home program before applying to our hospital,
• Pseudo-paralysis that are diseases that may show symptoms similar to BPBI (clavicle or humerus fracture only, pseudo-paralysis not BPBI injury, glenohumeral joint septic arthritis, arthrogryposis multiplex congenita (AMC), cerebral palsy, spinal cord ischemic injury, spinal cord congenital aplasia, spinal tumor, congenital radial palsy).

• Minimum Eligible Age: 15 Days
• Maximum Eligible Age: 90 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Kıvanç Delioğlu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kıvanç Delioğlu, Assist Prof

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Akin Uzumcugil, Assoc Prof

Role: STUDY_CHAIR

Hacettepe University

Ebru Ozturk, PhD

Role: STUDY_CHAIR

Hacettepe University

Mintaze Kerem, Professor

Role: STUDY_CHAIR

Hacettepe University

Locations

Hacettepe University, Faculty of Physical Therapy Rehabilitation

Ankara, Altındağ, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GO 23/12

Identifier Type: -

Identifier Source: org_study_id