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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05401513
Other study ID # LCCB2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 20, 2022
Est. completion date November 1, 2022

Study information

Verified date June 2022
Source Universidade Federal do Rio Grande do Norte
Contact Jamilson Simões Brasileiro, PhD
Phone 3342-2008
Email jamilson.brasileiro@ufrn.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 16
Est. completion date November 1, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 38 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil Federal University of Rio Grande do Norte Natal RN

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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'. Change from baseline in low back pain sensation at 6 weeks and 12 weeks after the intervention protocol
Secondary Functional disability associated to back pain 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
Secondary Back muscle fatigue 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
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