Brachial Plexus PalsyNCT06415747
Early Pain Finding in Infants With Brachial Plexus Birth Injury
An observational study of Brachial Plexus Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 90 days
- Conditions the study is for
- Brachial Plexus Palsy
- What is being tested?
- Observational pain and motor function assessments, and also comorbidities assessments with x-ray.
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 90 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy Rehabilitation
Ankara, Altındağ, 06230
About this study
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
- Being tested
- Observational pain and motor function assessments, and also comorbidities assessments with x-ray.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational pain and motor function assessments, and also comorbidities assessments with x-ray.Other
There was no intervention in our study, only observational and quantitative clinical evaluations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational pain and motor function assessments, and also comorbidities assessments with x-ray. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comorbidities
In 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. In our university hospital, humerus or scapula fracture, glenohumeral joint dislocation, torticollis and plagiocephaly, facial nerve palsy, phrenic nerve palsy, Horner's syndrome, and central nervous system disorders are checked with clinical examinations and X-ray to record as a comorbidities and additional problems.
Measured: Baseline, initial examination of children with BPBI who applied for medical follow-up.
Active Movement Scale - Motor Function Assessment
The AMS is a standardized assessment of 15 active joint movements on the affected side using an eight-point scale. The 15 movements were assessed by the AMS include. For each movement, the range of 0-4 points is evaluated in gravity eliminated position, while the range of 5-7 represents movement against gravity. The AMS-Total score is the sum of the scores of all 15 movements and represents the total function of the affected upper extremity, therefore the score can range from 0 to 105 points, with 0 being poor and 105 being the best score.
Measured: Baseline, initial examination of children with BPBI who applied for medical follow-up.
Flacc Pain Scale
The FLACC Pain Scale is an observational behavioral scale developed by Merkel et al. in 1997. It provides a simple and consistent method for the assessment of pain in early childhood, especially in the age group when the child cannot verbally express his pain. It is used to evaluate procedural and postoperative pain in children older than 1 month. The FLACC scale is used to assess pain at rest, during a medical procedure or during various environmental stimuli. It scores 5 behaviors of the infant, including facial expression, leg movements, activities, crying and consolability, between 0 and 2 points. The scale produces a total pain score between 0 and 10 points.
Measured: Baseline, initial examination of children with BPBI who applied for medical follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jan 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus PalsyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kıvanç Delioğlu, Hacettepe University
- Investigators
- Kıvanç Delioğlu, Assist Prof, Principal investigator, Hacettepe UniversityAkin Uzumcugil, Assoc Prof, Study chair, Hacettepe UniversityEbru Ozturk, PhD, Study chair, Hacettepe UniversityMintaze Kerem, Professor, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415747
- Sponsor's protocol ID
- GO 23/12
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Pain Finding in Infants With Brachial Plexus Birth Injury
- ClinicalTrials.gov ID
- NCT06415747
- Acronym / sponsor ID
- GO 23/12
- Conditions
- Brachial Plexus Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brachial Plexus Birth Injury | – | Other: Observational pain and motor function assessments, and also comorbidities assessments with x-ray.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. |
Who may qualify
- Ages
- 15 to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Brachial Plexus Birth Injury |
Primary outcome
Comorbidities
Time frame: Baseline, initial examination of children with BPBI who applied for medical follow-up.
In 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. In our university hospital, humerus or scapula fracture, glenohumeral joint dislocation, torticollis and plagiocephaly, facial nerve palsy, phrenic nerve palsy, Horner's syndrome, and central nervous system disorders are checked with clinical examinations and X-ray to record as a comorbidities and additional problems.
Active Movement Scale - Motor Function Assessment
Time frame: Baseline, initial examination of children with BPBI who applied for medical follow-up.
The AMS is a standardized assessment of 15 active joint movements on the affected side using an eight-point scale. The 15 movements were assessed by the AMS include. For each movement, the range of 0-4 points is evaluated in gravity eliminated position, while the range of 5-7 represents movement against gravity. The AMS-Total score is the sum of the scores of all 15 movements and represents the total function of the affected upper extremity, therefore the score can range from 0 to 105 points, with 0 being poor and 105 being the best score.
Flacc Pain Scale
Time frame: Baseline, initial examination of children with BPBI who applied for medical follow-up.
The FLACC Pain Scale is an observational behavioral scale developed by Merkel et al. in 1997. It provides a simple and consistent method for the assessment of pain in early childhood, especially in the age group when the child cannot verbally express his pain. It is used to evaluate procedural and postoperative pain in children older than 1 month. The FLACC scale is used to assess pain at rest, during a medical procedure or during various environmental stimuli. It scores 5 behaviors of the infant, including facial expression, leg movements, activities, crying and consolability, between 0 and 2 points. The scale produces a total pain score between 0 and 10 points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kıvanç Delioğlu, Assist Prof principal investigator
Hacettepe University
Akin Uzumcugil, Assoc Prof study chair
Hacettepe University
Ebru Ozturk, PhD study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Palsy, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comorbidities (time frame: Baseline, initial examination of children with BPBI who applied for medical follow-up.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.