NCT04513730

Positional Device Aimed at Patients With Low Back Pain

Development of a Positional Device Aimed at Patients With Reduced Mobility and Functional Capacity Due to Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Universidade Metodista de Piracicaba · Academic / Other
• Sex: All
• Age: 25 Years – 61 Years
• Healthy volunteers: Not accepted

Summary

The project aims to idealize a pelvic suspension device as an auxiliary physiotherapeutic resource for patients with reduced mobility and functional capacity, which should favor autonomous and independent performance in personal, social and work tasks of the target population. This is a controlled clinical trial study. The research sample will be composed of patients of both sexes, aged 21 to 65 years, diagnosed with low back pain, referred to UEAFTO/UEPA, through the SUS care network. The research participants will be evaluated by posture, active mobility and muscle strength of the spine, evaluation of pain intensity and functional capacity. A device will be built with the function of keeping the user in position of pelvic suspension promoting lumbar traction that will consist of a structure of pvc pipes and connections and padded material. Participants will be submitted to 10 sessions of use of the device, after which they will be reevaluated through the same procedures. The information collected will be analyzed through the Graphpad prism software. To compare measured values, the Shapiro-Wilk test will be used for normality distribution. Student's t-tests will be used for the treatment of variables with normal distribution, and Fisher's and Mann-Whitney's exact tests for variables without normal distribution. It is expected to collaborate in the social integration, labor and quality of life of people affected by low back pain, as well as to promote the development of low-cost technologies in the routine of Physiotherapy and public health in the State of Pará.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Rehabilitation	A device originally designed with the function of keeping the user in a comfortable position of pelvic suspension, in dorsal decubitus, with fixation in the popliteal region and ankles was built to promote lumbar traction. The device is designed in autoCAD software with 2d technical representations and 3d electronic model. It consists of a structure of pipes and fittings and padded material at the support points.

Timeline

• Start date: 2020-08-11
• Primary completion: 2021-03-30
• Completion: 2021-03-30
• First posted: 2020-08-14
• Last updated: 2021-04-28

Locations

1 site across 1 country: Brazil