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Pilates Method in Helicopter Pilots With Low Back Pain

Primary Purpose

Low Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pilates Group
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, physiotherapy, muscle fatigue

Eligibility Criteria

20 Years - 38 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal University of Rio Grande do Norte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pilates Group

Control Group

Arm Description

12-weeks exercise program, twice a week, with Pilates method exercises.

12-weeks maintaining their normal physical activity routine.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

Functional disability associated to back pain
To analyze the self-report low back pain disability through the Roland Morris Disability questionnaire.
Back muscle fatigue
Measure the back muscular resistance to fatigue using the Ito test

Full Information

First Posted
May 29, 2022
Last Updated
June 2, 2022
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT05401513
Brief Title
Pilates Method in Helicopter Pilots With Low Back Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2022 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, physiotherapy, muscle fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilates Group
Arm Type
Experimental
Arm Description
12-weeks exercise program, twice a week, with Pilates method exercises.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
12-weeks maintaining their normal physical activity routine.
Intervention Type
Other
Intervention Name(s)
Pilates Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Painful sensation
Description
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'.
Time Frame
Change from baseline in low back pain sensation at 6 weeks and 12 weeks after the intervention protocol
Secondary Outcome Measure Information:
Title
Functional disability associated to back pain
Description
To analyze the self-report low back pain disability through the Roland Morris Disability questionnaire.
Time Frame
Change from baseline in disability at 6 weeks and 12 weeks after the intervention protocol
Title
Back muscle fatigue
Description
Measure the back muscular resistance to fatigue using the Ito test
Time Frame
Change from baseline in back muscle fatigue at 6 weeks and 12 weeks after the intervention protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamilson Simões Brasileiro, PhD
Phone
3342-2008
Email
jamilson.brasileiro@ufrn.br
First Name & Middle Initial & Last Name or Official Title & Degree
Lidiane Cristina Correia Bulhões, Msc
Phone
84 99107-5568
Email
lidianeccorreia@hotmail.com
Facility Information:
Facility Name
Federal University of Rio Grande do Norte
City
Natal
State/Province
RN
ZIP/Postal Code
59140-840
Country
Brazil

12. IPD Sharing Statement

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Pilates Method in Helicopter Pilots With Low Back Pain

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