Low Back PainNCT05401513
Pilates Method in Helicopter Pilots With Low Back Pain
A study testing Pilates Group in people with Low Back Pain, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The purpose of this study is to analyze the effects of an exercise program, based on the Pilates method, on the low back pain and muscle fatigue of Brazilian Air Force helicopter pilots. Read more about this study
- Who is it for?
- Ages 20 to 38 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pilates Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jun 2022to 1 Nov 2022
- 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 20 to 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Brazilian Air Force helicopter instructors - Natal Air Base;
- Nonspecific low back pain for more than 3 months with a score of 2 or more at Numerical Pain Rating Scale.
Who cannot join
- Be undergoing physiotherapeutic treatment during the study period;
- Corticosteroids treatment in the last two weeks;
- Anti-inflammatory treatment in the previous 72 hours;
- Have specific spinal pathologies, such as spondylitis, spondylolysis, spondylolisthesis, disc herniation with radiculopathy or those who have had spinal surgery in the last year or who have a recent history of spinal fracture.
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 Program Based on the Pilates Method in Brazilian Air Force Helicopter Pilots With Low Back Pain: Randomized Controlled Trial
The purpose of this study is to analyze the effects of an exercise program, based on the Pilates method, on the low back pain and muscle fatigue of Brazilian Air Force helicopter pilots.
Read the detailed description
Methods: This is a randomized controlled trial composed by Brazilian Air Force helicopter instructors. The volunteers will be submitted to an initial evaluation composed by painful sensation, analyzed through the Numerical Pain Scale, disability associated with low back pain, using the Roland Morris Disability Questionnaire, and back muscle fatigue, through the Ito test. The pilots will be randomly assigned to the Exercise Group (exercise program based on the Pilates method, twice a week for 12 weeks) and Control Group (no intervention). After the sixth and 12th week of the beginning of the intervention program a new evaluation will be carried out, identical to the initial one.
- Conditions
- Low Back Pain
- Being tested
- Pilates Group
- Keywords
- low back pain, physiotherapy, muscle fatigue
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates GroupOther
The individuals of the Pilates group will perform specific exercises of the method, which will involve mobility, stability and muscular resistance. The exercises will progress according to the level of difficulty (basic, intermediate and advanced), load and repetition every three or four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Experimental | 12-weeks exercise program, twice a week, with Pilates method exercises. Receives: Other: Pilates Group |
| Control Group | No intervention | 12-weeks maintaining their normal physical activity routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Painful sensation
To compare the painful sensation in the lumbar region using the Numerical Pain Rating Scale (NPRS) across a range of 11, with 0 being described as 'no pain' and 10 as 'worst possible pain'.
Measured: Change from baseline in low back pain sensation at 6 weeks and 12 weeks after the intervention protocol
Secondary outcomes (2)
Functional disability associated to back pain
To analyze the self-report low back pain disability through the Roland Morris Disability questionnaire.
Measured: Change from baseline in disability at 6 weeks and 12 weeks after the intervention protocol
Back muscle fatigue
Measure the back muscular resistance to fatigue using the Ito test
Measured: Change from baseline in back muscle fatigue at 6 weeks and 12 weeks after the intervention protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start20 Jun 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 16 participants (estimated)
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
- NCT05401513
- Sponsor's protocol ID
- LCCB2022
- Status last verified
- Jun 2022
- First submitted
- 29 May 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exercise Program Based on the Pilates Method in Brazilian Air Force Helicopter Pilots With Low Back Pain: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05401513
- Acronym / sponsor ID
- LCCB2022
- Conditions
- Low Back Pain
- Keywords
- low back pain, physiotherapy, muscle fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 20 Jun 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 2 Jun 2022 (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.
The purpose of this study is to analyze the effects of an exercise program, based on the Pilates method, on the low back pain and muscle fatigue of Brazilian Air Force helicopter pilots.
Detailed description
Methods: This is a randomized controlled trial composed by Brazilian Air Force helicopter instructors. The volunteers will be submitted to an initial evaluation composed by painful sensation, analyzed through the Numerical Pain Scale, disability associated with low back pain, using the Roland Morris Disability Questionnaire, and back muscle fatigue, through the Ito test. The pilots will be randomly assigned to the Exercise Group (exercise program based on the Pilates method, twice a week for 12 weeks) and Control Group (no intervention). After the sixth and 12th week of the beginning of the intervention program a new evaluation will be carried out, identical to the initial one.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: Pilates Group12-weeks exercise program, twice a week, with Pilates method exercises. |
| Control Group | No intervention | –12-weeks maintaining their normal physical activity routine. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Brazilian Air Force helicopter instructors - Natal Air Base;
- Nonspecific low back pain for more than 3 months with a score of 2 or more at Numerical Pain Rating Scale.
Key exclusion criteria (4 listed)
- Be undergoing physiotherapeutic treatment during the study period;
- Corticosteroids treatment in the last two weeks;
- Anti-inflammatory treatment in the previous 72 hours;
- Have specific spinal pathologies, such as spondylitis, spondylolysis, spondylolisthesis, disc herniation with radiculopathy or those who have had spinal surgery in the last year or who have a recent history of spinal fracture.
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 |
|---|---|---|
| Pilates GroupThe individuals of the Pilates group will perform specific exercises of the method, which will involve mobility, stability and muscular resistance. The exercises will progress according to the level of difficulty (basic, intermediate and advanced), load and repetition every three or four weeks. | Other | Pilates Group |
Primary outcome
Painful sensation
Time frame: Change from baseline in low back pain sensation at 6 weeks and 12 weeks after the intervention protocol
To compare the painful sensation in the lumbar region using the Numerical Pain Rating Scale (NPRS) across a range of 11, with 0 being described as 'no pain' and 10 as 'worst possible pain'.
2 secondary outcomes
Functional disability associated to back pain
Time frame: Change from baseline in disability at 6 weeks and 12 weeks after the intervention protocol
Back muscle fatigue
Time frame: Change from baseline in back muscle fatigue at 6 weeks and 12 weeks after the intervention protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
Related trials for Low Back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy
Facet Joint Arthropathy, Pain
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Recruiting
Meditation for Older Adults With Chronic Low Back Pain
Chronic Low Back Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Group 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 4 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: status not confirmed, as of the sponsor's last update on 6 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamilson Simões Brasileiro, PhD (3342-2008, jamilson.brasileiro@ufrn.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Painful sensation (time frame: Change from baseline in low back pain sensation at 6 weeks and 12 weeks after the intervention protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2022.