Pilates Method in Helicopter Pilots With Low Back Pain

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05401513
• Other study ID #: LCCB2022
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

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