Surgical Repercussions in Respiratory System in Patients With Post-Traumatic Brachial Plexus Injuries: A Prospective Cohort Study

• ClinicalTrials.gov Identifier: NCT03377712
• Recruitment Status: Completed
• First Posted: December 19, 2017
• Last Update Posted: April 16, 2019
• Sponsor: Universidade Federal de Pernambuco
• Information provided by (Responsible Party): Helen Fisio, Universidade Federal de Pernambuco

Study Description

Brief Summary:

To evaluate the surgical repercussions in patients with traumatic brachial plexus injury in the respiratory and motor systems, trunk biomechanics, functional capacity and quality of life.

Condition or disease	Intervention/treatment
Brachial Plexus Injury; Respiratory Evaluation	Device: optoelectronic plethysmography; Device: diaphragmatic ultrasound; Device: Postural evaluation; Device: Pain evaluation; Device: Evaluation of the function; Device: Functional capacity assessment; Device: Quality of life assessment

Detailed Description:

Type of study will be a prospective cohort. The study will be performed at the Laboratory of Cardiopulmonary Physiotherapy of the Federal University of Pernambuco (UFPE). The sample will be calculated from a pilot study to be previously performed. The pilot study should have 10 individuals, 5 patients in each of the two groups. A group of patients who has brachial plexus injury and a group of healthy individuals for the pairing by sex and age. Eligibility criteria: patients who will undergo surgical intervention (within one year of the trauma), of both sexes, between 20 and 45 years of age, sedentary (oriented and encouraged to perform the activities of daily living at home, however , outside of any rehabilitation program) and encouraged to refrain from using tobacco. Patients with pulmonary contusions, severe pneumopathies, patients with congestive heart failure (NYHA class III or IV), diabetes mellitus, coronary artery disease, hemodynamic instability (MAP <60 mmHg), multiple thorax fractures, amputation of one limb cognitive changes. Physiotherapeutic evaluations will be performed by a single physiotherapist trained in the preoperative one, three and six months after surgery for brachial plexus injury. The instruments of evaluation included are: optoelectronic plethysmography, spirometry, manovacuometry, diaphragmatic ultrasound, g-walk, upper limb dynamometry, pain questionnaires (Mcgill and DN4), upper limb functionality questionnaire (DASH) minutes and the quality of life questionnaire (Whoquol). Expected Results: The greatest impact should be to assist the patient in the prevention and physiotherapeutic treatment in relation to the possible sequels arising from the surgical process, besides fomenting the literature, expanding the knowledge about the subject and determining the applicability of the existing therapeutic resources, so that these are not used indiscriminately in daily practice.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 6 Months
• Official Title: SURGICAL REPERCUSSIONS IN RESPIRATORY SYSTEM, TRUNK BIOMECHANICAL, FUNCTIONAL CAPACITY AND QUALITY OF LIFE IN PATIENTS WITH POST-TRAUMATIC BRACHIAL PLEXUS INJURIES: A PROSPECTIVE COHORT STUDY
• Actual Study Start Date: January 2, 2018
• Actual Primary Completion Date: December 21, 2018
• Actual Study Completion Date: March 26, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Brachial Plexus Injury group; Patients who will be submitted to the surgical procedure and monitored for the repercussions of the surgery. Interventions: optoelectronic plethysmography, diaphragmatic ultrasound, postural evaluation, functional capacity, pain evaluation, function and quality of life	Device: optoelectronic plethysmography; Evaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations; Device: diaphragmatic ultrasound; Evaluates the diaphragmatic mobility through images, simple and non-invasive use; Device: Postural evaluation; Evaluates the patient's posture through photos and filming, rapid examination, simple and non-invasive; Device: Pain evaluation; by means of questionnaires; Device: Evaluation of the function; through questionnaires; Device: Functional capacity assessment; Evaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment; Device: Quality of life assessment; through questionnaire
Paired group; Healthy individuals who will be matched by sex and age with the group of patients who will effectively undergo the surgical process. Interventions: optoelectronic plethysmography, diaphragmatic ultrasound, postural evaluation and functional capacity.	Device: optoelectronic plethysmography; Evaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations; Device: diaphragmatic ultrasound; Evaluates the diaphragmatic mobility through images, simple and non-invasive use; Device: Postural evaluation; Evaluates the patient's posture through photos and filming, rapid examination, simple and non-invasive

Outcome Measures

Primary Outcome Measures :

1. thoracoabdominal kinematics [ Time Frame: There will be two evaluations: one evaluation before surgery, another after six month ]
   It will be evaluated through optoelectronic plethysmography
2. mobility diaphragmatic [ Time Frame: There will be two evaluations: one evaluation before surgery, another after six month ]
   It will be evaluated by means of an ultrasound

Secondary Outcome Measures :

1. Postural evaluation [ Time Frame: There will be two evaluations: one evaluation before surgery, another after six month ]
   evaluates the patient's posture through photos, rapid examination, simple and non-invasive. Only the registration of images will be reactivated
2. Pain [ Time Frame: There will be two evaluations: one evaluation before surgery, another after six month ]
   evaluation by means of questionnaire
3. Evaluation of the function [ Time Frame: There will be two evaluations: one evaluation before surgery, another after six month ]
   through questionnaire - Arm, Shoulder and Hand Disability (DASH). The score is given by a formula: Sum of the first 30 questions, subtract 30 and then divide by 1.2 The higher the score, the worse the function of the upper limbs (always evaluating the two limbs at the same time).
4. Functional capacity assessment [ Time Frame: There will be four evaluations: one evaluation before surgery, another with one month, three and six months after the surgery ]
   Evaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment
5. Quality of life assessment [ Time Frame: There will be two evaluations: one evaluation before surgery, another after six month ]
   through questionnaire - World Health Organization Quality of Life Instrument (WHOQOL-Brief) - DOMAINS: Physical, Psychological, Social Relations, Environment and Self-evaluation of QOL. Score the higher the score, the better the quality of life of the patient.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

The study population will be composed of patients diagnosed with traumatic injury of the brachial plexus, at most one year of injury after the accident, confirmed by electromyography (ENMG), and who will undergo surgical intervention. The patients will be screened at the main reference center in Pernambuco, Recife Hospital / Recife

Criteria

Inclusion Criteria Patients who will undergo surgical intervention; male; between 20 and 45 years of age; sedentary.

Exclusion Criteria Pulmonary contusions; Severe pneumopathies; Diabetes mellitus; Coronary artery disease; Multiple thorax fractures; Amputation of one limb; Cognitive changes

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Contacts and Locations

Locations

Brazil

Helen Fuzari

Recife, PE, Brazil, 51021-360

Sponsors and Collaborators

Universidade Federal de Pernambuco

More Information

Additional Information:

• Responsible Party: Helen Fisio, Doctor student, Universidade Federal de Pernambuco
• ClinicalTrials.gov Identifier: NCT03377712
• Other Study ID Numbers: UFPE POSNEURO
• First Posted: December 19, 2017
• Last Update Posted: April 16, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Wounds and Injuries