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Positional Device Aimed at Patients With Low Back Pain

Not Applicable
Completed
Conditions
Low Back Pain
Interventions
Other: Rehabilitation
Registration Number
NCT04513730
Lead Sponsor
Universidade Metodista de Piracicaba
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
pelvic suspension deviceRehabilitationA 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.
Primary Outcome Measures
NameTimeMethod
Lumbar dynamometrypost treatment in 3 days

The dynamometer is an instrument used to assess muscle strength in individuals with normal health status and/or in the process of rehabilitation (EICHINGER et al., 2015). The lumbar dynamometer has the function of measuring the isometric strength of the extensor musculature of the Lumbar spine. The participant is positioned standing on the platform of the equipment with total extension of knees, trunk in flexion with about 120º and the head accompanies the extension of the trunk, the hands hold the dynamometer bar positioned previously. For learning, the participant performs two to three subm maxima contractions. Then, the maximum contraction is requested in 3 attempts with one minute of rest

Photogrammetric goniometrypost treatment in 3 days

Active mobility of the lumbar spine will be evaluated by means of photogrammetry with the same instruments of postural assessment. The flexion, extension, and lateral flexion movements on the right and left will be evaluated.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Universidade do Estado do Pará

🇧🇷

Belém, Pará, Brazil

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