Pilates Method in Helicopter Pilots With Low Back Pain

June 2, 2022 updated by: Jamilson Simões Brasileiro, Universidade Federal do Rio Grande do Norte

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • RN
      • Natal, RN, Brazil, 59140-840
        • Federal University of Rio Grande do Norte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pilates Group
12-weeks exercise program, twice a week, with Pilates method exercises.
Other: Pilates Group
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.
NO_INTERVENTION: Control Group
12-weeks maintaining their normal physical activity routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
Change from baseline in low back pain sensation at 6 weeks and 12 weeks after the intervention protocol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional disability associated to back pain
Time Frame: Change from baseline in disability at 6 weeks and 12 weeks after the intervention protocol
To analyze the self-report low back pain disability through the Roland Morris Disability questionnaire.
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
Measure the back muscular resistance to fatigue using the Ito test
Change from baseline in back muscle fatigue at 6 weeks and 12 weeks after the intervention protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio Grande do Norte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 20, 2022

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

November 1, 2022

Study Registration Dates

First Submitted

May 29, 2022

First Submitted That Met QC Criteria

May 29, 2022

First Posted (ACTUAL)

June 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCB2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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