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Exercise Protocol for Pilots With Back Pain.

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ClinicalTrials.gov Identifier: NCT03713814
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte

Tracking Information
First Submitted Date  ICMJE October 9, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date August 1, 2019
Actual Study Start Date  ICMJE February 1, 2019
Actual Primary Completion Date July 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • Change in number on Visual Analog Scale (VAS) of pain sensation in areas of the body (neck, shoulder, thoracic, low back spine, lower limbs) [ Time Frame: Change from Baseline pain sensation at 8 weeks. ]
    Quantification in number on Visual Analog Scale (VAS) of pain sensation in areas of the body (neck, shoulder, thoracic, low back spine, lower limbs), considering the last week. In the VAS (minimum:0, maximum:10) zero means no pain, ten means the worse pain.
  • Change of disability of the Lower Back Muscles (LBM) at the day, measured by Oswestry Disability index (ODI) [Pain/Function of LBM] [ Time Frame: Change from Baseline disability of the LBM at 8 weeks. ]
    Disability at the day measured by Oswestry Disability index (ODI). It has 10 six point scales. The sum of the 10 scores is expressed as a percentage of the maximum score. The first session gives the intensity of pain and the other 9 refer to the disabling effect on activities of daily living: personal care, weight lifting, sitting, walking, sleeping, sex life, social life, and traveling. The total score ranges from 0 (no disability) to 100 (disability maximum).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03713814 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • BMI in kg/m^2 [ Time Frame: Baseline. ]
    Weight and height will be combined to report BMI in kg/m^2.
  • Accumulated hours of flight [ Time Frame: Baseline . ]
    Accumulated hours of flight (from the beginning of the career until today).
  • Presence of cervical and lumbar musculoskeletal injuries by using Magnetic Resonance Imaging assessment [ Time Frame: Baseline. ]
    Presence of cervical and lumbar musculoskeletal injuries by using Magnetic Resonance Imaging assessment, evaluated by two physicians. The pilots will be directed to the Diagnostic Center by Image at the University Hospital Onofre Lopes (Natal-Rio Grande do Norte state,Brazil), where they will make the exams. The results will be referred by physicians to the researchers.
  • Change of the postural pattern [ Time Frame: Change from Baseline Postural Evaluation at 8 weeks. ]
    Clinical evaluation of postural pattern by a physical therapist using the postural evaluation software (SAPO).
  • Assessment of lumbar spine range of motion. [ Time Frame: Change from Baseline Strength of LBM at 8 weeks. ]
    The Iphone app called Ihandy level will be used by a physiotherapist in order to assess the range of motion of the lumbar spine in four movements: flexion, extension, right tilt and left tilt. The angles data will be recorded.
  • Change of Maximal Voluntary Isometric Contraction (MVIC) of Lower Back Muscles (LBM) measured in Newtons [ Time Frame: Change from Baseline Strength of LBM at 8 weeks. ]
    Maximal Voluntary Isometric Contraction (MVIC) of Lower Back Muscles (LBM) to be assessed similar to the protocol assessed by Nakagawa et al., 2015. The individual wil be requested to sustain isometry during 5 seconds, of 3 different positions of the trunk: flexion with rotation for the external oblique muscle MVIC measure and extension of trunk for iliocostalis MVIC measure. The testing order was randomised to account for ordering bias. It will be used the handheld dynamometer - Lafayette for the measure and it will be recorded in Newtons. The greatest measure will be chosen.
  • Change in number of affirmative answers for presence of referred musculoskeletal disorders, measured by Nordic Musculoskeletal Questionnaire. [ Time Frame: Change from Baseline Presence of musculoskeletal disorders at 8 weeks. ]
    Nordic Musculoskeletal Questionnaire - the aim of the questionnaire is to evaluate musculoskeletal problems in an ergonomic approach. The first part of the instrument consists of questions related to parts of the human body that correspond to nine anatomical areas (3 upper limbs, 3 lower limbs, 3 - trunk), marked in an illustration of the human body seen from the back. The questions are organized as follows: weekly and annual prevalence; functional disability; and health care research in the last 12 months. The instrument will be answered by the pilot individually; scribbling yes or no to each question
  • Change of time in seconds of sustained isometry in 3 positions of trunk (flexion, extension and side-bridge) [Endurance of Lower Back Muscles (LBM)] [ Time Frame: Change from Baseline Endurance of LBM at 8 weeks. ]
    Endurance of LBM will be measured by the seconds of sustained isometry in 3 position (flexion with rotation, extension and side-bridge). The time will be counted by clock chronometer.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • BMI in kg/m^2 [ Time Frame: Baseline. ]
    Weight and height will be combined to report BMI in kg/m^2.
  • Accumulated hours of flight [ Time Frame: Baseline . ]
    Accumulated hours of flight (from the beginning of the career until today).
  • Presence of cervical and lumbar musculoskeletal injuries by using Magnetic Resonance Imaging assessment [ Time Frame: Baseline. ]
    Presence of cervical and lumbar musculoskeletal injuries by using Magnetic Resonance Imaging assessment, evaluated by two physicians. The pilots will be directed to the Diagnostic Center by Image at the University Hospital Onofre Lopes (Natal-Rio Grande do Norte state,Brazil), where they will make the exams. The results will be referred by physicians to the researchers.
  • Change of the postural pattern [ Time Frame: Change from Baseline Postural Evaluation at 8 weeks. ]
    Clinical evaluation of postural pattern by a physical therapist using a posturography and recorded by camera.
  • Change of Mean of Root-mean-square (RMS) and median frequency (Fmed) assessed during 1 hour of flight [muscles electromyographic activation and fatigue- in-flight ] [ Time Frame: Change from Baseline RMS and Fmed - in-flight - at 8 weeks. ]
    Mean of Root-mean-square (RMS) and median frequency (Fmed) -assessing the electromyographic activation and fatigue of the following muscles in flight: Oblique External and iliocostalis muscles.
  • Change of Maximal Voluntary Isometric Contraction (MVIC) of Lower Back Muscles (LBM) measured in Newtons [ Time Frame: Change from Baseline Strength of LBM at 8 weeks. ]
    Maximal Voluntary Isometric Contraction (MVIC) of Lower Back Muscles (LBM) to be assessed similar to the protocol assessed by Nakagawa et al., 2015. The individual wil be requested to sustain isometry during 5 seconds, of 3 different positions of the trunk: flexion with rotation for the external oblique muscle MVIC measure, extension of trunk for iliocostalis MVIC measure and right side bridge. The testing order was randomised to account for ordering bias. It will be used the handheld dynamometer - Lafayette for the measure and it will be recorded in Newtons. The greatest measure will be chosen.
  • Change of time in seconds of sustained isometry in 3 positions of trunk (flexion, extension and side-bridge) [Endurance of Lower Back Muscles (LBM)] [ Time Frame: Change from Baseline Endurance of LBM at 8 weeks. ]
    Endurance of LBM will be measured by the seconds of sustained isometry in 3 position (flexion with rotation, extension and side-bridge). The time will be counted by clock chronometer.
  • Change in number of affirmative answers for presence of referred musculoskeletal disorders, measured by Nordic Musculoskeletal Questionnaire. [ Time Frame: Change from Baseline Presence of musculoskeletal disorders at 8 weeks. ]
    Nordic Musculoskeletal Questionnaire - the aim of the questionnaire is to evaluate musculoskeletal problems in an ergonomic approach. The first part of the instrument consists of questions related to parts of the human body that correspond to nine anatomical areas (3 upper limbs, 3 lower limbs, 3 - trunk), marked in an illustration of the human body seen from the back. The questions are organized as follows: weekly and annual prevalence; functional disability; and health care research in the last 12 months. The instrument will be answered by the pilot individually; scribbling yes or no to each question
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Protocol for Pilots With Back Pain.
Official Title  ICMJE Effects of an Exercise Protocol for Pilots With Back Pain.
Brief Summary

It is known that the low back pain can cause discomfort and deconcentration during the flight, requests for abstention of flight, fear in the aviators about the future in case of illness and economic damages to the country. However, there are few studies about the incidence, prevalence or risk factors associated with low back pain in Brazilian air force pilots. Also, the literature lacks further randomized controlled studies about interventions, leaving a huge field to be explored in future research.

Objectives: This study to analyze the chronic effects of an exercise protocol on lumbar pain in Brazilian Air Force pilots.

Materials and methods: The study is a blind and randomized clinical trial, in which a protocol of strength and lumbar resistance exercises will be tested. The volunteers will be: 20 fighter instructors with intermittent low back pain. Such volunteers will be recruited in a non-probabilistic manner for convenience. Moreover, they will be randomly distributed through www.randomization.com to form two groups with 10 members each: experimental group (EG), where they will participate in an exercise program three times a week for 8 weeks; and the control group (CG), in which they will receive explanation and handbook demonstration of the same exercises (Appendix 1) - after 8 weeks of intervention and after being reevaluated.

The study will be performed at the city of Natal/ Rio Grande do Norte. The evaluation will consist of an evaluation form with personal data, anthropometric data, occupational information, health history, physical exercise pattern and pain information, quantified by Visual Analog Pain Scale. In addition, the Oswestry questionnaire will be administered to assess lumbar function and the Nordic Questionnaire to assess musculoskeletal changes. Also, will be done: postural evaluation, using a postural evaluation software (SAPO); assessment of lumbar range of motion, using an IPHONE app called iHandy Level; Magnetic Resonance Imaging of the spine; dynamometry to measure the trunk extension force, flexion with rotation and lateral bridge, using the manual dynamometer Lafayette® - model 01165, USA; and resistance test of trunk stabilizing muscles. Magnetic resonance imaging will be done at the Onofre Lopes University Hospital. The project will be submitted to the Research Ethics Committee of the Federal University of Rio Grande do Norte through the national interface "Plataforma Brasil". The study will also be registered on the international clinical trial platform, ClinicalTrials.gov.

Data analysis: The Statistical Package for Social Science (SPSS) software will be used in the analysis. The normality of data distribution and the homogeneity of the variances will be verified by the Kolmogorov-Smirnov (K-S) and Levine tests, respectively. If there is a normal distribution, the descriptive statistics will be performed through means and standard deviations. Significance level adopted: 5% (P <0.05). The paired t test was used for the comparisons between the measurements obtained in the pre and post 2 month evaluations, and for the comparison between the groups (CG and EG), the unpaired t test. If the data do not present a normal distribution, the Friedman test will be used for comparisons of the measures of the evaluations in each group and the Kruskal-Wallis test for comparisons between the groups (CG and EG).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE Other: Exercise

8-week exercise program, three times a week, during 45 minutes each section. Exercises for strength, endurance and mobility of the spine using pilates´ball and mat.

The researcher will explain, demonstrate and supervise the participants. It will start with 10 minutes of warming-up using a ergometer bicycle, followed by the mat exercises. Some of these will require motor control with mobility, others will require isometry, or concentric and eccentric phases with progression of eccentric phase timing.

Study Arms  ICMJE
  • Experimental: Experimental Group
    8-week exercise program, three times a week, during 45 minutes each section. Exercises for strength, endurance and mobility of the spine using pilates´ball and mat.
    Intervention: Other: Exercise
  • No Intervention: Control group
    After the 8 weeks of intervention, the pilots will receive explanation and handbook demonstration of the same exercises.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 10, 2019
Actual Primary Completion Date July 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is fight pilot.
  • Subject is flight instructor from the Brazilian Air Force.

Exclusion Criteria:

  • Had not flown in the last 3 months
  • History of acute lower back pain in the week of the evaluation
  • Physical therapy during the study period
  • History of heart disease or uncontrolled hypertension
  • History of neurological disease
  • History of rheumatic disease
  • History of diabetes
  • Do not perform the evaluation procedures correctly.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713814
Other Study ID Numbers  ICMJE PSLD2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
Study Sponsor  ICMJE Universidade Federal do Rio Grande do Norte
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Federal do Rio Grande do Norte
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP