Low Back Pain Clinical Trial
Official title:
Effects of an Exercise Protocol for Pilots With Back Pain.
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).
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