Clinical trial NCT06415747: Early Pain Finding in Infants With Brachial Plexus Birth Injury
Official title: Early Pain Finding in Infants With Brachial Plexus Birth Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brachial Plexus Palsy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 59
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: -In retrospective data collection, it was determined that 76 babies with BPBI and their families applied to our hospital for their first medical check or examination. Inclusion criteria were as follows: 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. Seventeen children who were excluded because they did not meet the inclusion criteria (4 had started physiotherapy or a home program, 1 had humerus fracture without BPBI, 1 had congenital radial palsy, 2 had AMC, 1 had spinal tumor, 8 were older than 90 days). Hence, 59 children with BPBI were included in the study.

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.


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).

Primary outcomes:
measure: Comorbidities
timeFrame: Baseline, initial examination of children with BPBI who applied for medical follow-up.
measure: Active Movement Scale - Motor Function Assessment
timeFrame: Baseline, initial examination of children with BPBI who applied for medical follow-up.
measure: Flacc Pain Scale
timeFrame: Baseline, initial examination of children with BPBI who applied for medical follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University, Faculty of Physical Therapy Rehabilitation
state: Altındağ
Study officials:
affiliation: Hacettepe University
name: Kıvanç Delioğlu, Assist Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Akin Uzumcugil, Assoc Prof
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ebru Ozturk, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Mintaze Kerem, Professor
role: STUDY_CHAIR
References: