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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04513730
Enrollment
20
Registered
2020-08-14
Start date
2020-08-11
Completion date
2021-03-30
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

OTHERRehabilitation

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.

Sponsors

Universidade Metodista de Piracicaba
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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 auto CAD software with 2d technical representations and 3d electronic model. It consists of a structure of PVC pipes and fittings and padded material at the support points. The structure design was based on anthropometric models according to Felisberto and Paschoarelli (2000). Participants belonging to both groups will receive information about the procedures performed including the objectives, risks and benefits and study protocol Participants belonging to the intervention group will be submitted to 10 pelvic suspension technique sessions using the functional prototype of the device.

Eligibility

Sex/Gender
ALL
Age
25 Years to 61 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lumbar dynamometrypost treatment in 3 daysThe 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 daysActive 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026