Positional Device Aimed at Patients With Low Back Pain

Universidade Metodista de Piracicaba

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04513730

F110821

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 25 to 61 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with low back pain

Exclusion criteria

• patients with a history of vertebral surgery
• patients with spinal tumors
• patients with intervertebral disc infections
• patients with vertebral fractures
• patients with severe osteoporosis
• patients with ankylosing processes of the spine
• patients with heart diseases

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

pelvic suspension device

Experimental group

Description:

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.

Treatment:

Other: Rehabilitation