Clinical trial NCT03713814: Exercise Protocol for Pilots With Back Pain.
Official title: Effects of an Exercise Protocol for Pilots With Back Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Electromyography
Exercise therapy
Muscle Strength Dynamometer
Pilots
Back Pain
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 20
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in number on Visual Analog Scale (VAS) of pain sensation in areas of the body (neck, shoulder, thoracic, low back spine, lower limbs)
timeFrame: Change from Baseline pain sensation at 8 weeks.
measure: Change of disability of the Lower Back Muscles (LBM) at the day, measured by Oswestry Disability index (ODI) [Pain/Function of LBM]
timeFrame: Change from Baseline disability of the LBM at 8 weeks.
Secondary outcomes:
measure: BMI in kg/m^2
timeFrame: Baseline.
measure: Accumulated hours of flight
timeFrame: Baseline .
measure: Presence of cervical and lumbar musculoskeletal injuries by using Magnetic Resonance Imaging assessment
timeFrame: Baseline.
measure: Change of the postural pattern
timeFrame: Change from Baseline Postural Evaluation at 8 weeks.
measure: Assessment of lumbar spine range of motion.
timeFrame: Change from Baseline Strength of LBM at 8 weeks.
measure: Change of Maximal Voluntary Isometric Contraction (MVIC) of Lower Back Muscles (LBM) measured in Newtons
timeFrame: Change from Baseline Strength of LBM at 8 weeks.
measure: Change in number of affirmative answers for presence of referred musculoskeletal disorders, measured by Nordic Musculoskeletal Questionnaire.
timeFrame: Change from Baseline Presence of musculoskeletal disorders at 8 weeks.
measure: Change of time in seconds of sustained isometry in 3 positions of trunk (flexion, extension and side-bridge) [Endurance of Lower Back Muscles (LBM)]
timeFrame: Change from Baseline Endurance of LBM at 8 weeks.
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Federal University of Rio Grande do Norte
state: RN
Study officials:
References:
citation: Mendes PRF, Gomes SRA, Costa LDO, Liguori ADAL, Bulhoes LCC, Brasileiro JS. Core stabilisation exercises reduce chronic low back pain in Air Force fighter pilots: a randomised controlled trial. BMJ Mil Health. 2024 Jan 25;170(1):31-36. doi: 10.1136/bmjmilitary-2021-002005.