Low Back PainNCT03713814
Exercise Protocol for Pilots With Back Pain.
A study testing Exercise in people with Low Back Pain, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2019to 10 Jul 2019
- Phase
- Interventional
- 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 25 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is fight pilot.
- Subject is flight instructor from the Brazilian Air Force.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59140-840
About this study
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.
Read more
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).
- Conditions
- Low Back Pain
- Being tested
- Exercise
- Keywords
- Electromyography, Exercise therapy, Muscle Strength Dynamometer, Pilots, Back Pain
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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 group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Other: Exercise |
| Control group | No intervention | After the 8 weeks of intervention, the pilots will receive explanation and handbook demonstration of the same exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number on Visual Analog Scale (VAS) of pain sensation in areas of the body (neck, shoulder, thoracic, low back spine, lower limbs)
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.
Measured: Change from Baseline pain sensation at 8 weeks.
Change of disability of the Lower Back Muscles (LBM) at the day, measured by Oswestry Disability index (ODI) [Pain/Function of LBM]
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).
Measured: Change from Baseline disability of the LBM at 8 weeks.
Secondary outcomes (8)
BMI in kg/m^2
Weight and height will be combined to report BMI in kg/m^2.
Measured: Baseline.
Accumulated hours of flight
Accumulated hours of flight (from the beginning of the career until today).
Measured: Baseline .
Presence of cervical and lumbar musculoskeletal injuries by using Magnetic Resonance Imaging assessment
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.
Measured: Baseline.
Change of the postural pattern
Clinical evaluation of postural pattern by a physical therapist using the postural evaluation software (SAPO).
Measured: Change from Baseline Postural Evaluation at 8 weeks.
Assessment of lumbar spine range of motion.
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.
Measured: Change from Baseline Strength of LBM at 8 weeks.
Change of Maximal Voluntary Isometric Contraction (MVIC) of Lower Back Muscles (LBM) measured in Newtons
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.
Measured: Change from Baseline Strength of LBM at 8 weeks.
Change in number of affirmative answers for presence of referred musculoskeletal disorders, measured by Nordic Musculoskeletal Questionnaire.
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
Measured: Change from Baseline Presence of musculoskeletal disorders at 8 weeks.
Change of time in seconds of sustained isometry in 3 positions of trunk (flexion, extension and side-bridge) [Endurance of Lower Back Muscles (LBM)]
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.
Measured: Change from Baseline Endurance of LBM at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Feb 2019
- Primary completion10 Jul 2019
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713814
- Sponsor's protocol ID
- PSLD2018
- Status last verified
- Jul 2019
- First submitted
- 9 Oct 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35470256
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exercise Protocol for Pilots With Back Pain.
- ClinicalTrials.gov ID
- NCT03713814
- Acronym / sponsor ID
- PSLD2018
- Conditions
- Low Back Pain
- Keywords
- Electromyography, Exercise therapy, Muscle Strength Dynamometer, Pilots, Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 10 Jul 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 22 Oct 2018 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Exercise8-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. |
| Control group | No intervention | –After the 8 weeks of intervention, the pilots will receive explanation and handbook demonstration of the same exercises. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subject is fight pilot.
- Subject is flight instructor from the Brazilian Air Force.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Exercise8-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. | Other | Experimental Group |
Primary outcome
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).
8 secondary outcomes
BMI in kg/m^2
Time frame: Baseline.
Accumulated hours of flight
Time frame: Baseline .
Presence of cervical and lumbar musculoskeletal injuries by using Magnetic Resonance Imaging assessment
Time frame: Baseline.
Change of the postural pattern
Time frame: Change from Baseline Postural Evaluation at 8 weeks.
Assessment of lumbar spine range of motion.
Time frame: Change from Baseline Strength of LBM at 8 weeks.
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.
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.
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.
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 1 Aug 2019.
- Derived from this study: PubMed 35470256Mendes 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Low Back Pain, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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 2 inclusion and 8 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 1 Aug 2019. 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 Brazil. 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?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713814, which also lists 1 linked publication.
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 1 Aug 2019.